Similar packages
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Product
100mg1 x 100 -
Product
100mg1 x 100
Advocate (4 - 8 kg)
ATC code
Species
Cats and ferrets.
Indications
For cats suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and one or more of the other target parasites is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of ear mite infestation (Otodectes cynotis),
• the treatment of notoedric mange (Notoedres cati),
• the treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults),
• the prevention of lungworm disease (L3/L4 larvae of Aelurostrongylus abstrusus),
• the treatment of the lungworm Aelurostrongylus abstrusus (adults),
• the treatment of the lungworm Troglostrongylus brevior (adults),
• the treatment of the eye worm Thelazia callipaeda (adults),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and the prevention of heartworm disease is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).
Dose to be administered and administration route
To ensure a correct dosage, body weight should be determined as accurately as possible.
Dosage schedule for cats:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
|
Weight of cat [kg] |
Pipette size to be used |
Volume [ml] |
Imidacloprid [mg/kg bw] |
Moxidectin [mg/kg bw] |
|
≤ 4 kg |
Advocate for small cats |
0.4 |
minimum of 10 |
minimum of 1 |
|
> 4–8 kg |
Advocate for large cats |
0.8 |
10–20 |
1–2 |
|
> 8 kg |
the appropriate combination of pipettes |
|||
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine veterinary medicinal product treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the veterinary medicinal product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of notoedric mange (Notoedres cati)
A single dose of the veterinary medicinal product should be administered.
Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults)
A single dose of the veterinary medicinal product should be administered.
Prevention of Aelurostrongylus abstrusus
The veterinary medicinal product should be administered monthly.
Treatment of Aelurostrongylus abstrusus
The veterinary medicinal product should be administered monthly for three consecutive months.
Treatment of Troglostrongylus brevior (adults)
The veterinary medicinal productshould be administered monthly for two consecutive months.
Treatment of the eye worm Thelazia callipaeda (adults)
A single dose of the veterinary medicinal product should be administered.
Heartworm prevention (Dirofilaria immitis)
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 3.5 should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former veterinary medicinal product.
In non-endemic areas there should be no risk of cats having heartworm. Therefore, they can be treated without special precautions.
Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme)
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the veterinary medicinal product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Dosage schedule for ferrets:
One pipette of the veterinary medicinal product (0.4 ml) should be administered per animal. Do not exceed the recommended dose.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat administration after 2 weeks.
Heartworm prevention (Dirofilaria immitis)
Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 3.5 should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes.
In non-endemic areas there should be no risk of ferrets having heartworm. Therefore, they can be treated without special precautions.
Method of administration
External use.
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the veterinary medicinal product. Apply only to undamaged skin.
Adverse reactions
Cats and ferrets:
|
Rare (1 to 10 animals / 10,000 animals treated): |
Application site greasy fur1 Vomiting1 Hypersensitivity reaction (local) Erythema1 |
|
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): |
Behavioural disorder (e.g. agitation)2 Hypersalivation3,4 Neurological signs3 Pruritus5 Inappetence2, Lethargy2 |
1 These signs disappear without further treatment.
2 Transiently noted and related to sensation at application site.
3 If the animal licks the application site, in most cases transient.
4 This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.
5 In cats, transient.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocate 40 mg + 4 mg spot-on solution for small cats (≤ 4 kg) and ferrets Advocate 80 mg + 8 mg spot-on solution for large cats (> 4–8 kg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit dose (pipette) contains:
Active substances:
|
|
Unit dose |
Imidacloprid |
Moxidectin |
|
Advocate for small cats (≤ 4 kg) and ferrets |
0.4 ml |
40 mg |
4 mg |
|
Advocate for large cats (> 4–8 kg) |
0.8 ml |
80 mg |
8 mg |
Excipients:
|
Qualitative composition of excipients and other constituents |
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product |
|
Benzyl alcohol (E1519) |
|
|
Butylhydroxytoluene (E321) |
1 mg/ml |
|
Propylene carbonate |
|
Clear yellow to brownish solution.
3. CLINICAL INFORMATION
3.1 Target species
Cats and ferrets.
3.2 Indications for use for each target species
For cats suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and one or more of the other target parasites is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of ear mite infestation (Otodectes cynotis),
• the treatment of notoedric mange (Notoedres cati),
• the treatment of the lungworm Eucoleus aerophilus (syn.Capillaria aerophila) (adults),
• the prevention of lungworm disease (L3/L4 larvae of Aelurostrongylus abstrusus),
• the treatment of the lungworm Aelurostrongylus abstrusus (adults),
• the treatment of the lungworm Troglostrongylus brevior (adults),
• the treatment of the eye worm Thelazia callipaeda (adults),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and the prevention of heartworm disease is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).
3.3 Contraindications
Do not use in kittens under 9 weeks of age.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
For ferrets: Do not use Advocate for large cats (0.8 ml) or Advocate for dogs (any size).
Do not use in dogs. Instead, the corresponding “Advocate for dog” product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used for dogs.
Do not use on canaries.
3.4 Special warnings
The veterinary medicinal product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the veterinary medicinal product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the veterinary medicinal product.
The possibility that other animals in the same household can be a source of re-infection with fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm should be considered, and these should be treated as necessary with an appropriate product.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The treatment of cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on a benefit-risk assessment.
There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a benefit-risk assessment for these animals.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the veterinary medicinal product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.
Consider carefully the correct application method described in section 3.9, especially that the veterinary medicinal product should be applied to the site specified in order to minimise the risk for the animal to lick the veterinary medicinal product.
Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry.
It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the veterinary medicinal product to protect them from heartworm disease.
Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the veterinary medicinal product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.
In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the veterinary medicinal product alone may not be sufficient to prevent death of the animal.
The safety of the veterinary medicinal product has not been established in cats with severe clinical signs of T. brevior. Use of the veterinary medicinal product in such cases should be based on the benefit-risk assessment of the veterinarian.
Imidacloprid is toxic for birds, especially canaries.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product can cause skin, eye, or mouth irritation.
In very rare cases the veterinary medicinal product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the veterinary medicinal product may cause respiratory irritation in sensitive individuals.
People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution.
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms.
Other precautions:
The solvent in the veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
3.6 Adverse events
Cats and ferrets:
|
Rare (1 to 10 animals / 10,000 animals treated): |
Application site greasy fur1 Vomiting1 Hypersensitivity reaction (local) Erythema1 |
|
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): |
Behavioural disorder (e.g. agitation)2 Hypersalivation3,4 Neurological signs3 Pruritus5 Inappetence2, Lethargy2 |
1 These signs disappear without further treatment.
2 Transiently noted and related to sensation at application site.
3 If the animal licks the application site, in most cases transient.
4 This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site. 5 In cats, transient.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species.
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
3.8 Interaction with other medicinal products and other forms of interaction
During treatment with the veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.
No interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
3.9 Administration routes and dosage
To ensure a correct dosage, body weight should be determined as accurately as possible.
Dosage schedule for cats:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
|
Weight of cat [kg] |
Pipette size to be used |
Volume [ml] |
Imidacloprid [mg/kg bw] |
Moxidectin [mg/kg bw] |
|
≤ 4 kg |
Advocate for small cats |
0.4 |
minimum of 10 |
minimum of 1 |
|
> 4–8 kg |
Advocate for large cats |
0.8 |
10–20 |
1–2 |
|
> 8 kg |
the appropriate combination of pipettes |
|
||
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine veterinary medicinal product treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the veterinary medicinal product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of notoedric mange (Notoedres cati)
A single dose of the veterinary medicinal product should be administered.
Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults)
A single dose of the veterinary medicinal product should be administered.
Prevention of Aelurostrongylus abstrusus
The veterinary medicinal product should be administered monthly.
Treatment of Aelurostrongylus abstrusus
The veterinary medicinal product should be administered monthly for three consecutive months.
Treatment of Troglostrongylus brevior (adults)
The veterinary medicinal productshould be administered monthly for two consecutive months.
Treatment of the eye worm Thelazia callipaeda (adults)
A single dose of the veterinary medicinal product should be administered.
Heartworm prevention (Dirofilaria immitis)
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 3.5 should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former veterinary medicinal product.
In non-endemic areas there should be no risk of cats having heartworm. Therefore, they can be treated without special precautions.
Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme)
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the veterinary medicinal product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Dosage schedule for ferrets:
One pipette of the veterinary medicinal product (0.4 ml) should be administered per animal. Do not exceed the recommended dose.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat administration after 2 weeks.
Heartworm prevention (Dirofilaria immitis)
Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 3.5 should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes.
In non-endemic areas there should be no risk of ferrets having heartworm. Therefore, they can be treated without special precautions.
Method of administration
External use.
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the veterinary medicinal product. Apply only to undamaged skin.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.
The veterinary medicinal product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.
The veterinary medicinal product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code: QP54AB52
4.2 Pharmacodynamics
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the veterinary medicinal product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.
Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion. The veterinary medicinal product has a persistent action and protects cats for 4 weeks after a single application against reinfection with Dirofilaria immitis.
4.3 Pharmacokinetics
After topical administration of the veterinary medicinal product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat.
It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.
The mean t1/2 in cats ranges between 18.7 and 25.7 days.
Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in cats.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
None known.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
5.3 Special precautions for storage
Do not store above 30 °C.
5.4 Nature and composition of immediate packaging
Container material:
White polypropylene unit dose pipette closed with white polypropylene screw cap. Unit dose pipettes are packed in polyvinyl chloride and aluminium foil blisters.
Pack sizes:
Cardboard box containing a total of 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes in one or more blister sheets. Each unit dose pipette contains 0.4 ml or 0.8 ml of solution. Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Elanco Animal Health GmbH
7. MARKETING AUTHORISATION NUMBER(S)
EU/2/03/039/001-004
EU/2/03/039/013-014
EU/2/03/039/019-022
EU/2/03/039/031-038
8. DATE OF FIRST AUTHORISATION
02 April 2003
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
{DD month YYYY}
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocate 40 mg + 10 mg spot-on solution for small dogs (≤ 4 kg)
Advocate 100 mg + 25 mg spot-on solution for medium dogs (> 4–10 kg)
Advocate 250 mg + 62.5 mg spot-on solution for large dogs (> 10–25 kg)
Advocate 400 mg + 100 mg spot-on solution for extra-large dogs (> 25–40 kg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit dose (pipette) contains:
Active substances:
|
|
Unit dose |
Imidacloprid |
Moxidectin |
|
Advocate for small dogs (≤ 4 kg) |
0.4 ml |
40 mg |
10 mg |
|
Advocate for medium dogs (> 4–10 kg) |
1.0 ml |
100 mg |
25 mg |
|
Advocate for large dogs (> 10–25 kg) |
2.5 ml |
250 mg |
62.5 mg |
|
Advocate for extra-large dogs (> 25–40 kg) |
4.0 ml |
400 mg |
100 mg |
Excipients:
|
Qualitative composition of excipients and other constituents |
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product |
|
Benzyl alcohol (E1519) |
|
|
Butylhydroxytoluene (E321) |
1 mg/ml |
|
Propylene carbonate |
|
Clear yellow to brownish solution.
3. CLINICAL INFORMATION
3.1 Target species
Dogs.
3.2 Indications for use for each target species
For dogs suffering from, or at risk from, mixed parasitic infections.The veterinary medicinal product is only indicated when use against fleas and one or more of the other target parasites is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of biting lice (Trichodectes canis),
• the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of circulating microfilariae (Dirofilaria immitis),
• the treatment of cutaneous dirofilariosis (adult stages ofDirofilaria repens),
• the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),
• the reduction of circulating microfilariae (Dirofilaria repens),
• the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),
• the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
• the prevention of spirocercosis (Spirocerca lupi),
• the treatment of Eucoleus (syn. Capillaria)boehmi (adults),
• the treatment of the eye worm Thelazia callipaeda (adults),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
3.3 Contraindications
Do not use in puppies under 7 weeks of age.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.
Do not use in cats. Instead, the corresponding “Advocate for cats” product (0.4 or 0.8 ml), which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used for cats.
Do not use in ferrets. Only “Advocate for small cats and ferrets” (0.4 ml) must be used for ferrets.
Do not use on canaries.
3.4 Special warnings
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the veterinary medicinal product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the veterinary medicinal product.
The possibility that other animals in the same household can be a source of re-infection with fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm should be considered, and these should be treated as necessary with an appropriate product.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.
Efficacy against adult Dirofilaria repens has not been tested under field conditions.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The treatment of animals weighing less than 1 kg should be based on a benefit-risk assessment.
There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a benefit-risk assessment for these animals.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the veterinary medicinal product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.
Consider carefully the correct application method described in section 3.9, especially that the veterinary medicinal product should be applied to the site specified in order to minimise the risk for the animal to lick the veterinary medicinal product.
Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry.
When the veterinary medicinal product is applied in 3 to 4 separate spots (see section 3.9), specific care should be taken to prevent the animal licking the application sites.
This veterinary medicinal product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collie or Old English Sheep dogs and related breeds or crossbreeds, to correctly administer the veterinary medicinal product as described under section 3.9; in particular, oral uptake by Collie or Old English Sheep dogs and related breeds or crossbreeds should be prevented.
The safety of the veterinary medicinal product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore, the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit-risk assessment by the treating veterinarian.
Although experimental overdosage studies have shown that the veterinary medicinal product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the veterinary medicinal product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of the veterinary medicinal product has not been evaluated when administered on the same day as an adulticide.
Imidacloprid is toxic for birds, especially canaries.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product can cause skin, eye, or mouth irritation.
In very rare cases the veterinary medicinal product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the veterinary medicinal product may cause respiratory irritation in sensitive individuals.
People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution. Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the veterinary medicinal product is accidentally swallowed, seek medical advice immediatelyand show the package leaflet or label to the physician.
Special precautions for the protection of the environment:
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.
Other precautions:
The solvent in the veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
3.6 Adverse events
Dogs:
|
Common (1 to 10 animals / 100 animals treated): |
Diarrhoea1, Vomiting1 Cough1, Dyspnoea1, Tachypnoea1 Inappetence1, Lethargy1 |
|
Rare (1 to 10 animals / 10,000 animals treated): |
Vomiting
|
|
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): |
Application site greasy fur2, Application site hair loss2, Application site itching2, Application site reddening2 Behavioural disorder (e.g. agitation)3 Hypersalivation4 Neurological signs (e.g. ataxia, muscle tremor)5 Pruritus Inappetence3, Lethargy3 |
1 These signs are common in heartworm positive dogs with microfilaraemia, and there is a risk of gastrointestinal signs and severe respiratory signs that may require prompt veterinary treatment.
2 These signs disappear without further treatment.
3 Transiently noted and related to sensation at application site.
4 This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.
5 Most neurological signs occur transiently.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species.
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
3.8 Interaction with other medicinal products and other forms of interaction
During treatment with the veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.
No interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
Safety of the veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.
3.9 Administration routes and dosage
To ensure a correct dosage, body weight should be determined as accurately as possible.
Dosage schedule:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
|
Weight of dog [kg] |
Pipette size to be used |
Volume [ml] |
Imidacloprid [mg/kg bw] |
Moxidectin [mg/kg bw] |
|
≤ 4 kg |
Advocate for small dogs |
0.4 |
minimum of 10 |
minimum of 2.5 |
|
> 4–10 kg |
Advocate for medium dogs |
1.0 |
10–25 |
2.5–6.25 |
|
> 10–25 kg |
Advocate for large dogs |
2.5 |
10–25 |
2.5–6.25 |
|
> 25–40 kg |
Advocate for extra-large dogs |
4.0 |
10–16 |
2.5–4 |
|
> 40 kg |
the appropriate combination of pipettes |
|
||
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine the veterinary medicinal product treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of biting lice (Trichodectes canis)
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the veterinary medicinal product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)
A single dose should be administered twice 4 weeks apart.
Treatment of demodicosis (caused by Demodex canis)
The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases.
Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, the veterinary medicinal product can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Prevention of heartworm disease (D. immitis)
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 3.5 should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of dogs having heartworm. Therefore, they can be treated without special precautions.
Prevention of cutaneous dirofilariosis (skinworm) (D. repens)
For prevention of cutaneous dirofilariosis, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. repens larvae) are present. The veterinary medicinal product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month.
Treatment of microfilariae (D. immitis)
The veterinary medicinal product should be administered monthly for two consecutive months.
Treatment of cutaneous dirofilariosis (skinworm) (adult stages of Dirofilaria repens)
The veterinary medicinal product should be administered monthly for six consecutive months.
Reduction of microfilariae (skin worm) (D. repens)
The veterinary medicinal product should be administered monthly for four consecutive months.
Treatment and prevention of Angiostrongylus vasorum
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
In endemic areas regular monthly applications will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.
Treatment of Crenosoma vulpis
A single dose should be administered.
Prevention of spirocercosis (Spirocerca lupi)
The veterinary medicinal product should be administered monthly.
Treatment of Eucoleus (syn. Capillaria) boehmi (adults)
The veterinary medicinal product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.
Treatment of the eye worm Thelazia callipaeda (adults)
A single dose of the veterinary medicinal product should be administered.
Roundworm, hookworm and whipworm treatment (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala, Toxascaris leonina and Trichuris vulpis)
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the veterinary medicinal product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
Method of administration
External use.
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
For dogs up to 25 kg:
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
For dogs of more than 25 kg:
For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the veterinary medicinal product to run down the animal’s side.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.
The veterinary medicinal product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code: QP54AB52
4.2 Pharmacodynamics
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the veterinary medicinal product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.
Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion. The drug has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum.
4.3 Pharmacokinetics
After topical administration of the veterinary medicinal product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month. The t1/2 in dogs is about 28.4 days.
Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
None known.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
5.3 Special precautions for storage
Do not store above 30 °C.
5.4 Nature and composition of immediate packaging
Container material:
White polypropylene unit dose pipette closed with white polypropylene screw cap. Unit dose pipettes are packed in polyvinyl chloride and aluminium foil blisters.
Pack sizes:
Cardboard box containing a total of 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes in one or more blister sheets. Each unit dose pipette contains 0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml of solution. Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Elanco Animal Health GmbH
7. MARKETING AUTHORISATION NUMBER(S)
EU/2/03/039/005-012
EU/2/03/039/015-018
EU/2/03/039/023-030
EU/2/03/039/039-054
8. DATE OF FIRST AUTHORISATION
02 April 2003
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
{DD month YYYY}
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
ANNEX II
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
None.
ANNEX III
LABELLING AND PACKAGE LEAFLET
A. LABELLING
CARDBOARD BOX (pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate 40 mg + 4 mg spot-on solution for small cats (≤ 4 kg) and ferrets
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Each 0.4 ml pipette contains:
40 mg imidacloprid, 4 mg moxidectin.
|
3. |
PACKAGE SIZE |
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
|
4. |
TARGET SPECIES |
Ferrets
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
External use.
|
7. |
WITHDRAWAL PERIODS |
|
8. |
EXPIRY DATE |
Exp. {mm/yyyy}
|
9. |
SPECIAL STORAGE PRECAUTIONS |
Do not store above 30 °C.
|
10. |
THE WORDS “READ THE PACKAGE LEAFLET BEFORE USE” |
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Elanco logo
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/03/039/001 3 pipettes
EU/2/03/039/002 6 pipettes
EU/2/03/039/013 4 pipettes
EU/2/03/039/019 21 pipettes
EU/2/03/039/020 42 pipettes
EU/2/03/039/031 1 pipette
EU/2/03/039/032 2 pipettes
EU/2/03/039/033 9 pipettes
EU/2/03/039/034 12 pipettes
|
15. |
BATCH NUMBER |
Lot {number}
pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate 80 mg + 8 mg spot-on solution for large cats (> 4–8 kg)
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Each 0.8 ml pipette contains:
80 mg imidacloprid, 8 mg moxidectin.
|
3. |
PACKAGE SIZE |
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
|
4. |
TARGET SPECIES |
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
External use.
|
7. |
WITHDRAWAL PERIODS |
Do not store above 30
10.
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Elanco logo
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/03/039/003 3 pipettes
EU/2/03/039/004 6 pipettes
EU/2/03/039/014 4 pipettes
EU/2/03/039/021 21 pipettes
EU/2/03/039/022 42 pipettes
EU/2/03/039/035 1 pipette
EU/2/03/039/036 2 pipettes
EU/2/03/039/037 9 pipettes
EU/2/03/039/038 12 pipettes
|
15. |
BATCH NUMBER |
Lot {number}
pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate 40 mg + 10 mg spot-on solution for small dogs (≤ 4 kg)
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Each 0.4 ml pipette contains:
40 mg imidacloprid, 10 mg moxidectin.
|
3. |
PACKAGE SIZE |
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
|
4. |
TARGET SPECIES |
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
External use.
|
7. |
WITHDRAWAL PERIODS |
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Elanco logo
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/03/039/005 3 pipettes
EU/2/03/039/006 6 pipettes
EU/2/03/039/015 4 pipettes
EU/2/03/039/023 21 pipettes
EU/2/03/039/024 42 pipettes
EU/2/03/039/039 1 pipette
EU/2/03/039/040 2 pipettes
EU/2/03/039/041 9 pipettes
EU/2/03/039/042 12 pipettes
|
15. |
BATCH NUMBER |
Lot {number}
pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate 100 mg + 25 mg spot-on solution for medium dogs (> 4–10 kg)
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Each 1 ml pipette contains:
100 mg imidacloprid, 25 mg moxidectin.
|
3. |
PACKAGE SIZE |
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
|
4. |
TARGET SPECIES |
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
External use.
|
7. |
WITHDRAWAL PERIODS |
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Elanco logo
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/03/039/007 3 pipettes
EU/2/03/039/008 6 pipettes
EU/2/03/039/016 4 pipettes
EU/2/03/039/025 21 pipettes
EU/2/03/039/026 42 pipettes
EU/2/03/039/043 1 pipette
EU/2/03/039/044 2 pipettes
EU/2/03/039/045 9 pipettes
EU/2/03/039/046 12 pipettes
|
15. |
BATCH NUMBER |
Lot {number}
pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate 250 mg + 62.5 mg spot-on solution for large dogs (> 10–25 kg)
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Each 2.5 ml pipette contains:
250 mg imidacloprid, 62.5 mg moxidectin.
|
3. |
PACKAGE SIZE |
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
|
4. |
TARGET SPECIES |
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
External use.
|
7. |
WITHDRAWAL PERIODS |
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Elanco logo
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/03/039/009 3 pipettes
EU/2/03/039/010 6 pipettes
EU/2/03/039/017 4 pipettes
EU/2/03/039/027 21 pipettes
EU/2/03/039/028 42 pipettes
EU/2/03/039/047 1 pipette
EU/2/03/039/048 2 pipettes
EU/2/03/039/049 9 pipettes
EU/2/03/039/050 12 pipettes
|
15. |
BATCH NUMBER |
Lot {number}
pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate 400 mg + 100 mg spot-on solution for extra-large dogs (> 25–40 kg)
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Each 4 ml pipette contains:
400 mg imidacloprid, 100 mg moxidectin.
|
3. |
PACKAGE SIZE |
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
|
4. |
TARGET SPECIES |
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
External use.
|
7. |
WITHDRAWAL PERIODS |
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Elanco logo
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/03/039/011 3 pipettes
EU/2/03/039/012 6 pipettes
EU/2/03/039/018 4 pipettes
EU/2/03/039/029 21 pipettes
EU/2/03/039/030 42 pipettes
EU/2/03/039/051 1 pipette
EU/2/03/039/052 2 pipettes
EU/2/03/039/053 9 pipettes
EU/2/03/039/054 12 pipettes
|
15. |
BATCH NUMBER |
Lot {number}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for small cats and ferrets
PIPETTE
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
≤ 4 kg
0.4 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
Advocate for large cats PIPETTE
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
> 4–8 kg
0.8 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for small dogs PIPETTE
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
≤ 4 kg
0.4 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
Advocate for medium dogs PIPETTE
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
> 4–10 kg
1.0 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
Advocate for large dogs PIPETTE
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
> 10–25 kg
2.5 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
Advocate for extra-large dogs PIPETTE
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
> 25–40 kg
4.0 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for small cats and ferrets BLISTER
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
40 mg imidacloprid / 4 mg moxidectin
≤ 4 kg
0.4 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
Advocate for large cats BLISTER
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
80 mg imidacloprid / 8 mg moxidectin
> 4–8 kg
0.8 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for small dogs BLISTER
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
40 mg imidacloprid / 10 mg moxidectin
≤ 4 kg
0.4 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for medium dogs BLISTER
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
100 mg imidacloprid / 25 mg moxidectin
> 4–10 kg
1.0 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for large dogs BLISTER
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
250 mg imidacloprid / 62.5 mg moxidectin
> 10–25 kg
2.5 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for extra-large dogs BLISTER
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocate
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
400 mg imidacloprid / 100 mg moxidectin
> 25–40 kg
4.0 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
B. PACKAGE LEAFLET
PACKAGE LEAFLET
1. Name of the veterinary medicinal product
Advocate 40 mg + 4 mg spot-on solution for small cats (≤ 4 kg) and ferrets
Advocate 80 mg + 8 mg spot-on solution for large cats (> 4–8 kg)
2. Composition
Each unit dose (pipette) contains:
|
|
Unit dose |
Imidacloprid |
Moxidectin |
|
Advocate for small cats (≤ 4 kg) and ferrets |
0.4 ml |
40 mg |
4 mg |
|
Advocate for large cats (> 4–8 kg) |
0.8 ml |
80 mg |
8 mg |
Excipients:
Benzyl alcohol (E1519), 1 mg/ml Butylhydroxytoluene (E321), Propylene carbonate
Clear yellow to brownish solution.
3. Target species
Cats and ferrets. 
4. Indications for use
For cats suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and one or more of the other target parasites is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of ear mite infestation (Otodectes cynotis),
• the treatment of notoedric mange (Notoedres cati),
• the treatment of the lungworm Eucoleus aerophilus (syn.Capillaria aerophila) (adults),
• the prevention of lungworm disease (L3/L4 larvae of Aelurostrongylus abstrusus),
• the treatment of the lungworm Aelurostrongylus abstrusus (adults),
• the treatment of the lungworm Troglostrongylus brevior (adults),
• the treatment of the eye worm Thelazia callipaeda (adults),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and the prevention of heartworm disease is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).
5. Contraindications
Do not use in kittens under 9 weeks of age.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
For ferrets: Do not use Advocate for large cats (0.8 ml) or Advocate for dogs (any size).
Do not use in dogs. Instead, the corresponding “Advocate for dog” product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used for dogs.
Do not use on canaries.
6. Special warnings
Special warnings:
The veterinary medicinal product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the veterinary medicinal product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the veterinary medicinal product.
Unnecessary use of antiparasitics or use deviating from the instructions given in the Package leaflet may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.
The possibility that other animals in the same household can be a source of re-infection with fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm should be considered, and these should be treated as necessary with an appropriate product.
Special precautions for safe use in the target species:
The treatment of cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on a benefit-risk assessment.
There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a benefit-risk assessment for these animals.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the veterinary medicinal product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.
Consider carefully the correct application method described in “Advice on correct administration" section, especially that the veterinary medicinal product should be applied to the site specified in order to minimise the risk for the animal to lick the veterinary medicinal product.
Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry.
It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the veterinary medicinal product to protect them from heartworm disease.
Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the veterinary medicinal product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.
In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the veterinary medicinal product alone may not be sufficient to prevent death of the animal.
The safety of the veterinary medicinal product has not been established in cats with severe clinical signs of T. brevior. Use of the veterinary medicinal product in such cases should be based on the benefit-risk assessment of the veterinarian.
Imidacloprid is toxic for birds, especially canaries.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product can cause skin, eye, or mouth irritation.
In very rare cases the veterinary medicinal product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the veterinary medicinal product may cause respiratory irritation in sensitive individuals.
People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution.
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms.
Other precautions:
The solvent in the veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species.
The use is not recommended during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction:
During treatment with the veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.
No interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
Overdose:
Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.
The veterinary medicinal product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.
The veterinary medicinal product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.
7. Adverse events
Cats and ferrets:
|
Rare (1 to 10 animals / 10,000 animals treated): |
|
Application site greasy fur[1] Vomiting1 Hypersensitivity reaction (local) Erythema1 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
|
Behavioural disorder (e.g. agitation)[2] Neurological signs3 Pruritus5 Inappetence2, Lethargy2 |
Reporting adverse events is important. It allows continuous safety monitoring of a product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system: {national system details}.
8. Dosage for each species, routes and method of administration
External use.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Dosage schedule for cats:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
|
Weight of cat [kg] |
Pipette size to be used |
Volume [ml] |
Imidacloprid [mg/kg bw] |
Moxidectin [mg/kg bw] |
|
≤ 4 kg |
Advocate for small cats |
0.4 |
minimum of 10 |
minimum of 1 |
|
> 4–8 kg |
Advocate for large cats |
0.8 |
10–20 |
1–2 |
|
> 8 kg |
the appropriate combination of pipettes |
|
||
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine veterinary medicinal product treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the veterinary medicinal product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of notoedric mange (Notoedres cati)
A single dose of the veterinary medicinal product should be administered.
Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults)
A single dose of the veterinary medicinal product should be administered.
Prevention of Aelurostrongylus abstrusus
The veterinary medicinal product should be administered monthly.
Treatment of Aelurostrongylus abstrusus
The veterinary medicinal product should be administered monthly for three consecutive months.
Treatment of Troglostrongylus brevior (adults)
The veterinary medicinal product should be administered monthly for two consecutive months.
Treatment of the eye worm Thelazia callipaeda (adults)
A single dose of the veterinary medicinal product should be administered.
Heartworm prevention (Dirofilaria immitis)
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in the “Special warnings” section should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of cats having heartworm. Therefore, they can be treated without special precautions.
Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme)
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the veterinary medicinal product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Dosage schedule for ferrets:
One pipette of the veterinary medicinal product for small cats (0.4 ml) should be administered per animal. Do not exceed the recommended dose.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat administration after 2 weeks.
Heartworm prevention (Dirofilaria immitis)
Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in the “Special warnings” section should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes.
In non-endemic areas there should be no risk of ferrets having heartworm. Therefore, they can be treated without special precautions.
9. Advice on correct administration
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown in figure 1.
Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin as shown in figure 2. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin.
For monolingual packaging only:
<Figures are shown below. >
For multilingual packaging only:
< Figures are shown at the end of the leaflet.>
Figure 1
Figure 2
10. Withdrawal periods
Not applicable.
11. Special storage precautions
Keep out of the sight and reach of children. Do not store above 30 °C.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after Exp. The expiry date refers to the last day of that month.
12. Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
13. Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.
14. Marketing authorisation numbers and pack sizes
EU/2/03/039/001-004, EU/2/03/039/013-014, EU/2/03/039/019-022, EU/2/03/039/031-038
Pack sizes:
Cardboard box containing a total of 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes in one or more blister sheets. Each unit dose pipette contains 0.4 ml or 0.8 ml of solution. Not all pack sizes may be marketed.
15. Date on which the package leaflet was last revised
{MM/YYYY}
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
16. Contact details
Marketing authorisation holder and contact details to report suspected adverse reactions:
Elanco Animal Health GmbH, Alfred-Nobel-Str. 50, 40789 Monheim, Germany
|
België/Belgique/Belgien Tél/Tel: +32 33000338 PV.BEL@elancoah.com
|
Lietuva Tel: +372 8840389 PV.LTU@elancoah.com
|
|
|
|
Република България Teл: +48 221047815 PV.BGR@elancoah.com
|
Luxembourg/Luxemburg Tél/Tel: +352 20881943 PV.LUX@elancoah.com
|
|
|
|
Česká republika Tel: +420 228880231 |
Magyarország Tel.: +36 18506968 |
|
|
|
PV.CZE@elancoah.com
|
PV.HUN@elancoah.com
|
||
|
Danmark Tlf: +45 78775477 PV.DNK@elancoah.com
|
Malta Tel: +36 18088530 PV.MLT@elancoah.com
|
||
|
Deutschland Tel: +49 32221852372 PV.DEU@elancoah.com
|
Nederland Tel: +31 852084939 PV.NLD@elancoah.com
|
||
|
Eesti Tel: +372 8807513 PV.EST@elancoah.com
|
Norge Tlf: +47 81503047 PV.NOR@elancoah.com
|
||
|
Ελλάδα Τηλ: +386 82880097 PV.GRC@elancoah.com
|
Österreich Tel: +43 720116570 PV.AUT@elancoah.com
|
||
|
España Tel: +34 518890402 PV.ESP@elancoah.com
|
Polska Tel.: +48 221047306 PV.POL@elancoah.com
|
||
|
France Tél: +33 975180507 PV.FRA@elancoah.com
|
Portugal Tel: +351 308801355 PV.PRT@elancoah.com
|
||
|
Hrvatska Tel: +36 18088411 PV.HRV@elancoah.com
|
România Tel: +40 376300400 PV.ROU@elancoah.com
|
||
|
Ireland Tel: +44 3308221732 PV.IRL@elancoah.com
|
Slovenija Tel: +386 82880093 PV.SVN@elancoah.com
|
||
|
Ísland Sími: +45 89875379 PV.ISL@elancoah.com
|
Slovenská republika Tel: +420 228880231 PV.SVK@elancoah.com
|
||
|
Italia Tel: +39 0282944231 PV.ITA@elancoah.com
|
Suomi/Finland Puh/Tel: +358 753252088 PV.FIN@elancoah.com
|
||
|
Κύπρος Τηλ: +386 82880095 PV.CYP@elancoah.com
|
Sverige Tel: +46 108989397 PV.SWE@elancoah.com
|
||
|
Latvija Tel: +372 8840390 PV.LVA@elancoah.com
|
United Kingdom (Northern Ireland) Tel: +44 3308221732 PV.XXI@elancoah.com
|
||
Manufacturer responsible for batch release:
KVP Pharma + Veterinär Produkte GmbH, Projensdorfer Str. 324, 24106 Kiel, Germany
17. Other information
Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the veterinary medicinal product.
The veterinary medicinal product has a persistent action and protects cats for 4 weeks after a single application against reinfection with Dirofilaria immitis.
Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in cats.
PACKAGE LEAFLET
1. Name of the veterinary medicinal product
Advocate 40 mg + 10 mg spot-on solution for small dogs (≤ 4 kg)
Advocate 100 mg + 25 mg spot-on solution for medium dogs (> 4–10 kg)
Advocate 250 mg + 62.5 mg spot-on solution for large dogs (> 10–25 kg)
Advocate 400 mg + 100 mg spot-on solution for extra-large dogs (> 25–40 kg)
2. Composition
Each unit dose (pipette) contains:
|
|
Unit Dose |
Imidacloprid |
Moxidectin |
|
Advocate for small dogs (≤ 4 kg) |
0.4 ml |
40 mg |
10 mg |
|
Advocate for medium dogs (> 4–10 kg) |
1.0 ml |
100 mg |
25 mg |
|
Advocate for large dogs (> 10–25 kg) |
2.5 ml |
250 mg |
62.5 mg |
|
Advocate for extra-large dogs (> 25–40 kg) |
4.0 ml |
400 mg |
100 mg |
Excipients:
Benzyl alcohol (E1519), 1 mg/ml Butylhydroxytoluene (E321), Propylene carbonate Clear yellow to brownish solution.
3. Target species
Dogs. 
4. Indications for use
For dogs suffering from, or at risk from, mixed parasitic infections. The veterinary medicinal product is only indicated when use against fleas and one or more of the other target parasites is indicated at the same time:
• the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of biting lice (Trichodectes canis),
• the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of circulating microfilariae (Dirofilaria immitis),
• the treatment of cutaneous dirofilariosis (adult stages ofDirofilaria repens),
• the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),
• the reduction of circulating microfilariae (Dirofilaria repens),
• the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),
• the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
• the prevention of spirocercosis (Spirocerca lupi),
• the treatment of Eucoleus (syn. Capillaria)boehmi (adults),
• the treatment of the eye worm Thelazia callipaeda (adults),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
5. Contraindications
Do not use in puppies under 7 weeks of age.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.
Do not use in cats. Instead, the corresponding “Advocate for cats” product (0.4 or 0.8 ml), which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used for cats.
Do not use in ferrets. Only “Advocate for small cats and ferrets” (0.4 ml) must be used for ferrets.
Do not use on canaries.
6. Special warnings
Special warnings:
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the veterinary medicinal product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the veterinary medicinal product.
Unnecessary use of antiparasitics or use deviating from the instructions given in the Package leaflet may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.
The possibility that other animals in the same household can be a source of re-infection with fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm should be considered, and these should be treated as necessary with an appropriate product.
Efficacy against adult Dirofilaria repens has not been tested under field conditions.
Special precautions for safe use in the target species:
The treatment of animals weighing less than 1 kg should be based on a benefit-risk assessment.
There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a benefit-risk assessment for these animals.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the veterinary medicinal product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.
Consider carefully the correct application method described in the “Advice on correct administration” section, especially that the veterinary medicinal product should be applied to the site specified in order to minimise the risk for the animal to lick the veterinary medicinal product.
Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry.
When the veterinary medicinal product is applied in 3 to 4 separate spots (see the “Advice on correct administration” section), specific care should be taken to prevent the animal licking the application sites.
This veterinary medicinal product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collie or Old English Sheep dogs and related breeds or crossbreeds, to correctly administer the product as described under the “Advice on correct administration” section; in particular, oral uptake by Collie or Old English Sheep dogs and related breeds or crossbreeds should be prevented.
The safety of the veterinary medicinal product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore, the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit-risk assessment by the treating veterinarian.
Although experimental overdosage studies have shown that the veterinary medicinal product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the veterinary medicinal product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of the veterinary medicinal product has not been evaluated when administered on the same day as an adulticide.
Imidacloprid is toxic for birds, especially canaries.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product can cause skin, eye, or mouth irritation.
In very rare cases the veterinary medicinal product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the veterinary medicinal product may cause respiratory irritation in sensitive individuals.
People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution.
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may have harmful effects on aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.
Other precautions:
The solvent in the veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species.
The use is not recommended during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction:
During treatment with the veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.
No interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
Safety of the veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.
Overdose:
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.
The veterinary medicinal product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40% of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10% of the recommended dose produced no adverse effects.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.
7. Adverse events
Dogs:
Common (1 to 10 animals / 100 animals treated):
|
Diarrhoea1, Vomiting1 Cough1, Dyspnoea1, Tachypnoea1 Inappetence1, Lethargy1 |
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Rare (1 to 10 animals / 10,000 animals treated): |
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Vomiting |
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Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
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Application site greasy fur2, Application site hair loss2, Application site itching2, Application site reddening2 Behavioural disorder (e.g. agitation)3 Hypersalivation4 Neurological signs (e.g. ataxia, muscle tremor)5 Pruritus Inappetence3, Lethargy3 |
1 These signs are common in heartworm positive dogs with microfilaraemia, and there is a risk of gastrointestinal signs and severe respiratory signs that may require prompt veterinary treatment.
2 These signs disappear without further treatment.
3 Transiently noted and related to sensation at application site.
4 This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site. 5 Most neurological signs occur transiently.
Reporting adverse events is important. It allows continuous safety monitoring of a product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system: {national system details}.
8. Dosage for each species, routes and method of administration
External use.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Dosage schedule:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product.
For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
|
Weight of dog [kg] |
Pipette size to be used |
Volume [ml] |
Imidacloprid [mg/kg bw] |
Moxidectin [mg/kg bw] |
|
≤ 4 kg |
Advocate for small dogs |
0.4 |
minimum of 10 |
minimum of 2.5 |
|
> 4–10 kg |
Advocate for medium dogs |
1.0 |
10–25 |
2.5–6.25 |
|
> 10–25 kg |
Advocate for large dogs |
2.5 |
10–25 |
2.5–6.25 |
|
> 25–40 kg |
Advocate for extra-large dogs |
4.0 |
10–16 |
2.5–4 |
|
> 40 kg |
the appropriate combination of pipettes |
|
||
Flea treatment and prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine veterinary medicinal product treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of biting lice (Trichodectes canis)
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the veterinary medicinal product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)
A single dose should be administered twice 4 weeks apart.
Treatment of demodicosis (caused by Demodex canis)
The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, the veterinary medicinal product can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Prevention of heartworm disease (D. immitis)
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in “Special warnings” section should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of dogs having heartworm. Therefore, they can be treated without special precautions.
Prevention of cutaneous dirofilariosis (skinworm) (D. repens)
For prevention of cutaneous dirofilariosis, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. repens larvae) are present. The veterinary medicinal product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month.
Treatment of microfilariae (D. immitis)
The veterinary medicinal product should be administered monthly for two consecutive months.
Treatment of cutaneous dirofilariosis (skinworm) (adult stages of Dirofilaria repens)
The veterinary medicinal product should be administered monthly for six consecutive months.
Reduction of microfilariae (skinworm) (D. repens)
The veterinary medicinal product should be administered monthly for four consecutive months.
Treatment and prevention of Angiostrongylus vasorum
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
In endemic areas regular monthly applications will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.
Treatment of Crenosoma vulpis
A single dose should be administered.
Prevention of spirocercosis (Spirocerca lupi)
The veterinary medicinal product should be administered monthly.
Treatment of Eucoleus (syn. Capillaria) boehmi (adults)
The veterinary medicinal product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.
Treatment of the eye worm Thelazia callipaeda (adults)
A single dose of the veterinary medicinal product should be administered.
Roundworm, hookworm and whipworm treatment (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala, Toxascaris leonina and Trichuris vulpis)
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the veterinary medicinal product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
9. Advice on correct administration
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown in figure 1.
For dogs up to 25 kg:
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin as shown in figure 2.
For dogs of more than 25 kg:
For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail as shown in figure 3. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side.
For monolingual packaging only:
<Figures are shown below. >
For multilingual packaging only:
< Figures are shown at the end of the leaflet.>
Figure 1
Figure 2
Figure 3
10. Withdrawal periods
Not applicable.
11. Special storage precautions
Keep out of the sight and reach of children.
Do not store above 30 °C.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
12. Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
The veterinary medicinal product should not enter water courses as moxidectin and imidacloprid may be dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
13. Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.
14. Marketing authorisation numbers and pack sizes
EU/2/03/039/005-012, EU/2/03/039/015-018, EU/2/03/039/023-030, EU/2/03/039/039-054
Pack sizes:
Cardboard box containing a total of 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes in one or more blister sheets. Each unit dose pipette contains 0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml of solution. Not all pack sizes may be marketed.
15. Date on which the package leaflet was last revised
{MM/YYYY}
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
16. Contact details
Marketing authorisation holder and contact details to report suspected adverse reactions:
Elanco Animal Health GmbH, Alfred-Nobel-Str. 50, 40789 Monheim, Germany
|
België/Belgique/Belgien Tél/Tel: +32 33000338 |
Lietuva Tel: +372 8840389 |
|
PV.BEL@elancoah.com
|
PV.LTU@elancoah.com
|
|
Република България Teл: +48 221047815 PV.BGR@elancoah.com
|
Luxembourg/Luxemburg Tél/Tel: +352 20881943 PV.LUX@elancoah.com
|
|
Česká republika Tel: +420 228880231 PV.CZE@elancoah.com
|
Magyarország Tel.: +36 18506968 PV.HUN@elancoah.com
|
|
Danmark Tlf: +45 78775477 PV.DNK@elancoah.com
|
Malta Tel: +36 18088530 PV.MLT@elancoah.com
|
|
Deutschland Tel: +49 32221852372 PV.DEU@elancoah.com
|
Nederland Tel: +31 852084939 PV.NLD@elancoah.com
|
|
Eesti Tel: +372 8807513 PV.EST@elancoah.com
|
Norge Tlf: +47 81503047 PV.NOR@elancoah.com
|
|
Ελλάδα Τηλ: +386 82880097 PV.GRC@elancoah.com
|
Österreich Tel: +43 720116570 PV.AUT@elancoah.com
|
|
España Tel: +34 518890402 PV.ESP@elancoah.com
|
Polska Tel.: +48 221047306 PV.POL@elancoah.com
|
|
France Tél: +33 975180507 PV.FRA@elancoah.com
|
Portugal Tel: +351 308801355 PV.PRT@elancoah.com
|
|
Hrvatska Tel: +36 18088411 PV.HRV@elancoah.com
|
România Tel: +40 376300400 PV.ROU@elancoah.com
|
|
Ireland Tel: +44 3308221732 PV.IRL@elancoah.com
|
Slovenija Tel: +386 82880093 PV.SVN@elancoah.com
|
|
Ísland Sími: +45 89875379 PV.ISL@elancoah.com
|
Slovenská republika Tel: +420 228880231 PV.SVK@elancoah.com
|
|
Italia Tel: +39 0282944231 PV.ITA@elancoah.com
|
Suomi/Finland Puh/Tel: +358 753252088 PV.FIN@elancoah.com
|
|
Κύπρος Τηλ: +386 82880095 PV.CYP@elancoah.com
|
Sverige Tel: +46 108989397 PV.SWE@elancoah.com
|
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Latvija Tel: +372 8840390 PV.LVA@elancoah.com |
United Kingdom (Northern Ireland) Tel: +44 3308221732 PV.XXI@elancoah.com |
Manufacturer responsible for batch release:
KVP Pharma + Veterinär Produkte GmbH, Projensdorfer Str. 324, 24106 Kiel, Germany
17. Other information
Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the veterinary medicinal product.
Moxidectin has a persistent action and protects dogs for 4 weeks after a single application against reinfection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum.
Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.
[1] These signs disappear without further treatment.
[2] Transiently noted and related to sensation at application site.
[3] If the animal licks the application site, in most cases transient.
[4] This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site. 5 In cats, transient.
| Art. Nr. | 04895/5001 |
|---|---|
| GTIN | • • • • • • • • • 4352 |
