Animec

1 x 50 ml
Solution for injection
SC

Active substance

  • Ivermectin : 10 mg/ml
  • Species

    Cattle (beef and non-lactating dairy cattle), Sheep and Pigs.

    Indications

    Treatment of infections with the following parasites in beef and non-lactating dairy cattle, pigs and sheep:

    Cattle:

    Gastro-intestinal roundworms (adult and fourth stage larvae):

    Ostertagia spp. (including inhibited O.ostertagi)

    Haemonchus placei

    Trichostrongylus axei Trichostrongylus colubriformis

    Cooperia spp.

    Oesophagostomum radiatum

    Nematodirus helvetianus (adult)

    N. spathiger (adult)

    Lungworms (adult and fourth stage larvae):

    Dictyocaulus viviparus.

    Warbles:

    Hypoderma bovis

    H. lineatum.

    Mange mites:

    Psoroptes bovis

    Sarcoptes scabiei var. bovis.

    Sucking lice:

    Linognathus vituli

    Haematopinus eurysternus

    The use of the product in cattle should take into account geographical differences in the occurrence patterns of parasites.

    Pigs:

    Gastrointestinal roundworms: (adult and fourth stage larvae):

    Ascaris suum

    Hyostrongylus rubidus

    Oesophagostomum spp.

    Strongyloides ransomi (adult only)

    Lungworms:

    Metastrongylus spp. (adult)

    Lice:

    Haematopinus suis

    Mange mites:

    Sarcoptes scabiei var. suis

    Sheep:

    Gastrointestinal roundworms (adult and fourth-stage larvae):

    Teladorsagia circumcincta including inhibited larvae

    T. trifurcata

    Haemonchus contortus including inhibited larvae

    Trichostrongylus axei (adults)

    T. colubriformis and T. vitrinus (adults)

    Cooperia curticei

    Oesophagostomum columbianum

    O. venulosum (adults)

    Nematodirus filicollis

    Chabertia ovina Trichuris ovis (adults)

    Lungworms:

    Dictyocaulus filaria (adult and fourth-stage larvae)

    Protostrongylus rufescens (adults)

    Nasal bots (all larval stages):

    Oestrus ovis

    Mange mites:

    Psoroptes ovis

    Dose to be administered and administration route

    For single administration only by subcutaneous injection. Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle and sheep, and 33 kg of bodyweight of pigs. Replace with a fresh sterile needle after every 10 to 12 animals. Massage the injection site after administration of the product. Injection of wet or dirty animals is not recommended.

    Underdosing could result in ineffective use and may favour resistance development.

    To ensure a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one.

    Accuracy of the dosing device should be thoroughly checked.

    Cattle:

    The product should be given only by subcutaneous injection at the recommended dosage level of 200 µg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle. This is equivalent to 1 ml per 50 kg bodyweight.

    The volume administered per injection site should not exceed 10 ml.

    Pigs:

    In pigs, the recommended dosage level is 300 µg ivermectin per kg bodyweight. This is equivalent to 1 ml per 33 kg bodyweight. The recommended route of administration is by subcutaneous injection into the neck. The volume administered per injection site should not exceed 5ml.

    Young Pigs:

    In young pigs, especially those below 16 kg for which less that 0.5 ml of the product is indicated, dosing accurately is important. The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

    Sheep

    The recommended dose is 200 µg ivermectin per kg bodyweight (corresponding to 1 ml of the product per 50 kg bw) by subcutaneous injection over the neck.

    The volume administered per injection site should not exceed 1ml.

    For the treatment and control of sheep scab (Psoroptes ovis), two injections with a sevenday interval are required to treat clinical signs of scab and to eliminate mites.

    In young lambs weighing less than 25 kg give 0.1 ml of the product per 5 kg. The use of a syringe that can deliver as little as 0.1 ml is recommended.

    This product does not contain any antimicrobial preservative. Swab septum before removing each dose.

    Adverse reactions

    Cattle

    Transitory discomfort has been observed in some cattle. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment.

    Pigs

    Mild and transient pain reactions may be seen in some pigs.

    All these reactions disappeared without treatment.

    Sheep

    Immediately following subcutaneous injection, activity suggesting pain, sometimes intense but usually transient, has been observed in some sheep.

    Dispensing

    POM-VPS - Prescription Only Medicine – Veterinarian, Pharmacist, SQP

    SUMMARY OF THE PRODUCT CHARACTERISCS

    1. NAME OF VETERINARY MEDICINAL PRODUCT

    Animec 10 mg/ml solution for injection for Cattle, Pigs and Sheep

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    Each ml contains:

    Active substance: Ivermectin 10 mg

    Excipients:

    For the full list of excipients, see section 6.1.

    3. PHARMACEUTICAL FORM

    Solution for injection.

    Clear colourless to slight yellow-coloured solution with no visible particulates.

    4 CLINICAL PARTICULARS

    4.1 Target Species

    Cattle (beef and non-lactating dairy cattle), Sheep and Pigs.

    4.2 Indications for use, specifying the target species

    Treatment of infections with the following parasites in beef and non-lactating dairy cattle, pigs and sheep:

    Cattle:

    Gastro-intestinal roundworms (adult and fourth stage larvae):

    Ostertagia spp. (including inhibited O.ostertagi)

    Haemonchus placei

    Trichostrongylus axei Trichostrongylus colubriformis Cooperia spp.

    Oesophagostomum radiatum

    Nematodirus helvetianus (adult)

    N. spathiger (adult)

    Lungworms (adult and fourth stage larvae):

    Dictyocaulus viviparus.

    Warbles: Hypoderma bovis H. lineatum.

    Mange mites:

    Psoroptes bovis

    Sarcoptes scabiei var. bovis.

    Sucking lice:

    Linognathus vituli

    Haematopinus eurysternus

    The use of the product in cattle should take into account geographical differences in the occurrence patterns of parasites.

    Pigs:

    Gastrointestinal roundworms: (adult and fourth stage larvae):

    Ascaris suum

    Hyostrongylus rubidus

    Oesophagostomum spp.

    Strongyloides ransomi (adult only)

    Lungworms:

    Metastrongylus spp. (adult)

    Lice:

    Haematopinus suis

    Mange mites:

    Sarcoptes scabiei var. suis

    Sheep:

    Gastrointestinal roundworms (adult and fourth-stage larvae):

    Teladorsagia circumcincta including inhibited larvae

    T. trifurcata

    Haemonchus contortus including inhibited larvae

    Trichostrongylus axei (adults)

    T. colubriformis and T. vitrinus (adults)

    Cooperia curticei

    Oesophagostomum columbianum

    O. venulosum (adults)

    Nematodirus filicollis

    Chabertia ovina Trichuris ovis (adults)

    Lungworms:

    Dictyocaulus filaria (adult and fourth-stage larvae) Protostrongylus rufescens (adults)

    Nasal bots (all larval stages): Oestrus ovis

    Mange mites:

    Psoroptes ovis

    4.3 Contraindications

    Do not administer by the intravenous or intramuscular route.

    Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs or cats as severe adverse reactions may occur (see also section 4.5).

    4.4 Special warnings for each target species

    In sheep treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although a clinical improvement may be seen, elimination of all mites may not occur.

    Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. To ensure complete control great care must be taken to avoid re–infestation, as mites may be viable for up to 15 days off the sheep. It is important that all sheep which have been in contact with infected sheep are treated. Contact between treated, infected and untreated flocks must be avoided until at least seven days after treatment.

    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 herd or flock.

    Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd or flock, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd or flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated

    (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd/flock should be sought from the responsible veterinarian.

    Resistance to ivermectin has been reported in Cooperia spp. and in Ostertagia ostertagi in cattle. Resistance has also been reported in Haemonchus contortus in cattle outside the EU.

    In sheep, resistance to ivermectin is widespread in Teladorsagia circumcincta, Trichostrongylus spp., Haemonchus contortus and in other gastro-intestinal parasite species.

    Multiple resistance was reported in Teladorsagia circumcincta to benzimidazoles, macrocyclic lactones and levamisole and in Haemonchus contortus to ivermectin and benzimidazoles.

    Multiple resistance to macrocyclic lactones has also been reported in Psoroptes ovis scab mites in sheep and in cattle.

    The use of this product should take into account local information about susceptibility of the target parasites, where available. It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.

    4.5 Special precautions for use

    Special precautions for use in animals

    In cattle, to avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites. Consult your veterinarian on the correct timing of treatment.

    Avermectins may not be well tolerated in non-target species. Cases of intolerance with fatal results are reported in dogs – especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises. In addition, care should be taken to avoid ingestion of spilled product or access to used containers by these other species.

    Since ivermectin is highly bound to plasma proteins, special care should be taken in cases of sick animals or in nutritional conditions associated with low plasma protein levels.

    Special precautions to be taken by the person administering the veterinary medicinal product to animals

    This product may cause eye and skin irritation. Avoid contact with skin or eyes. In case of skin or eye contact, wash exposed area with plenty of clean water. If symptoms persist, seek medical advice.

    Take care to avoid accidental self-injection: the product may cause local irritation and/or pain at the site of injection. In case of accidental self-injection, seek immediate medical advice and show the information leaflet or the label to the physician.

    Do not eat or smoke while handling the product. Wash hands after use.

    Other precautions

    The product is very toxic to aquatic organisms and dung insects.

    Long term effects on dung insects caused by continuous or repeated use cannot be excluded therefore repeated treatment of animals on a pasture with an ivermectincontaining product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian.

    Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.

    4.6 Adverse reactions (frequency and seriousness)

    Cattle

    Transitory discomfort has been observed in some cattle. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment.

    Pigs

    Mild and transient pain reactions may be seen in some pigs.

    All these reactions disappeared without treatment.

    Sheep

    Immediately following subcutaneous injection, activity suggesting pain, sometimes intense but usually transient, has been observed in some sheep.

    4.7 Use during pregnancy, lactation or lay

    The product can be administered during pregnancy and lactation in cows, ewes and sows. The product does not affect fertility. It can be used in breeding cows and bulls, breeding ewes and rams, in sows and boars.

    4.8 Interaction with other medicinal products and other forms of interaction

    Do not combine with vaccination against lungworm. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.

    4.9 Amounts to be administered and administration route

    For single administration only by subcutaneous injection. Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle and sheep, and 33 kg of bodyweight of pigs. Replace with a fresh sterile needle after every 10 to 12 animals. Massage the injection site after administration of the product. Injection of wet or dirty animals is not recommended.

    Underdosing could result in ineffective use and may favour resistance development.

    To ensure a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one.

    Accuracy of the dosing device should be thoroughly checked.

    Cattle:

    The product should be given only by subcutaneous injection at the recommended dosage level of 200 µg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle. This is equivalent to 1 ml per 50 kg bodyweight.

    The volume administered per injection site should not exceed 10 ml.

    Pigs:

    In pigs, the recommended dosage level is 300 µg ivermectin per kg bodyweight. This is equivalent to 1 ml per 33 kg bodyweight. The recommended route of administration is by subcutaneous injection into the neck. The volume administered per injection site should not exceed 5ml.

    Young Pigs:

    In young pigs, especially those below 16 kg for which less that 0.5 ml of the product is indicated, dosing accurately is important. The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

    Sheep

    The recommended dose is 200 µg ivermectin per kg bodyweight (corresponding to 1 ml of the product per 50 kg bw) by subcutaneous injection over the neck.

    The volume administered per injection site should not exceed 1ml.

    For the treatment and control of sheep scab (Psoroptes ovis), two injections with a sevenday interval are required to treat clinical signs of scab and to eliminate mites.

    In young lambs weighing less than 25 kg give 0.1 ml of the product per 5 kg. The use of a syringe that can deliver as little as 0.1 ml is recommended.

    This product does not contain any antimicrobial preservative. Swab septum before removing each dose.

    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

    In the case of overdose a symptomatic treatment should be given.

    Cattle

    Single doses of 4 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

    Pigs

    A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.

    Sheep

    At dose levels up to 4 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

    No antidote has been identified; however, symptomatic therapy may be beneficial.

    4.11 Withdrawal Period(s)

    Cattle

    Meat and offal: 49 days.

    Do not use in lactating cows producing milk for human consumption. Do not use in cattle producing milk for human consumption or in dairy cows within 60 days prior to calving.

    Pigs

    Meat and offal: 28 days.

    Sheep

    Meat and offal: 25 days

    Do not use in lactating sheep producing milk for human consumption.

    Do not use in sheep within 60 days of lambing where milk is to be used for human consumption.

    5 PHARMACOLOGICAL PROPERTIES

    Pharmacotherapeutic Group: Endectocides ATCvet code: QP54AA01.

    5.1 Pharmacodynamic properties

    Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of this class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

    The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the bloodbrain barrier.

    5.2 Pharmacokinetic properties

    Cattle

    Maximum plasma concentration

    At a dose level of 200 µg ivermectin per kg a maximum plasma concentration of 35-50 ng/ml is reached in ± 2 days.

    It is also established that ivermectin is carried mainly in the plasma (80%). This distribution between plasma and blood cells remains relatively constant.

    Excretion: length of time and route

    Only about 1-2% is excreted in the urine the remainder is excreted in the faeces, approximately 60% of which is excreted as unaltered drug. The remainder is excreted as metabolites or degradation products.

    Pig

    Maximum plasma concentration

    During trials carried out at a dose level of 300 µg ivermectin per kg bodyweight, peak plasma concentrations were reached in 3 (±0.5) days.

    Excretion: length of time and route

    Biliary excretion is also the major route of ivermectin excretion in pigs.

    Sheep

    At a dose level of 200 µg ivermectin per kg bodyweight, a mean Cmax of 10.976 ng/mL was reached at a mean Tmax of 40 hours, and the mean elimination half-life was 73.9 hours.

    Excretion: length of time and route

    The major route of excretion of ivermectin and its metabolites in sheep is faeces (99%) and 1% being excreted in the urine.

    Environmental properties

    Like other macrocyclic lactones, Ivermectin has the potential to adversely affect non-target organisms. Following treatment, excretion of potentially toxic levels of Ivermectin may take place over a period of several weeks. Faeces containing Ivermectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.

    6 PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

    Glycerol

    Glycerol Formal

    6.2 Major Incompatibilities

    In the absence of incompatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

    6.3 Shelf-life

    Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 28 days.

    6.4 Special precautions for storage

    This veterinary medicinal product does not require any special storage precautions.

    6.5 Nature and composition of immediate packaging

    Multidose polyethylene bottles of 50 ml, 250 ml and 500 ml sealed with bromobutyl seals and aluminium overseals.

    Not all pack sizes may be marketed.

    6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

    The product should not enter water courses as this may be dangerous to fish and other aquatic organisms.

    7 MARKETING AUTHORISATION HOLDER

    Chanelle Animal Health Limited

    7 Rodney Street

    Liverpool

    L1 9HZ

    United Kingdom

    8 MARKETING AUTHORISATION NUMBER

    Vm 11990/5001

    9 DATE OF THE FIRST AUTHORISATION

    21 September 2000

    10 DATE OF REVISION OF THE TEXT

    January 2024

    Approved 02 January 2024

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    Product identification - 11990/5001
    Art. Nr. 11990/5001
    PACKAGES
    Animec
    Chanelle Pharma
    1 x 50 ml
    11990/5001
    Animec
    Chanelle Pharma
    1 x 250 ml
    11990/5001
    Animec
    Chanelle Pharma
    1 x 500 ml
    11990/5001
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