SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Imidaflea 250 mg Spot-on solution for Large Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 ml contains:

Active substance: Imidacloprid 250 mg

Excipients:

Butylhydroxytoluene (E 321) 2.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Spot-on solution

Clear yellow to slightly brownish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For the prevention and treatment of flea infestations and for the treatment of biting lice (Trichodectes canis) on dogs from 10 kg to less than 25 kg body weight. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks.

4.3 Contraindications

Do not treat unweaned puppies of less than 8 weeks of age.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

If signs of disease persist or appear, consult a veterinary surgeon.

4.5 Special precautions for use

Special precautions for use in animals

This product is for topical use and should not be administered orally.

Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient animal.

Do not allow recently treated animals to groom each other.

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

This product can cause mucous membrane, skin and eye irritation.

Therefore, contact of the product with mouth, skin and eyes should be avoided. This product contains benzyl alcohol and may cause skin sensitisation or transient skin reactions in rare cases (for example, irritation, tingling).

People with a known hypersensitivity (allergy) to insecticides or alcohol should avoid contact with the product.

Do not smoke, drink or eat during application.

If contact with the skin occurs, wash hands with soap and water.

If the product gets into eyes, the eyes should be thoroughly rinsed with clean water. If skin or eye irritation persists, or the product is accidentally swallowed, seek medical advice.

Do not stroke, groom or play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.

Dispose of used pipettes immediately. Wash hands after use.

Other Precautions

Imidacloprid is toxic to aquatic organisms. To avoid adverse effects on aquatic organisms, treated dogs should not be allowed to enter surface water for 48 hours after treatment.

4.6 Adverse reactions (frequency and seriousness)

The product is bitter tasting and salivation may occasionally occur if the dog licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. (see also section 4.9 Amounts to be administered and administration route).

In very rare occasions skin reactions such as hair loss, redness, itching and skin lesions may occur.

Agitation and disorientation has also been reported. Excessive salivation and nervous signs such as incoordination, tremors and depression have also been reported exceptionally in dogs.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

No primary embryotoxic, teratogenic or reproductive toxic effects have been observed during the studies with imidacloprid on rats and rabbits. Studies on pregnant and lactating bitches together with their offspring are limited. Evidence so far suggests that no adverse effects are to be expected in these animals. Consult your veterinary surgeon before using in pregnant or nursing animals.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use simultaneously with other flea products which are applied directly onto the animal.

4.9 Amounts to be administered and administration route

This product is for external use only and should not be administered orally. Animals should be weighed accurately prior to treatment.

Dosage and Treatment Schedule

Dog (kg body weight)	Product	Number of Pipettes	Advaprid (mg/kg body weight)
From 10 kg to less than 25 kg	Advaprid 250 for Dogs	1 x 2.5 ml	minimum of 10

Re-infestation from emergence of new fleas in the environment may continue to occur for six weeks or longer after treatment is initiated. More than one treatment may therefore be required, depending on the level of fleas in the environment. To aid in environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developing stages is recommended.

The product remains effective if the animal becomes wet, for example after swimming or exposure to heavy rain.

However, in cases of frequent swimming or bathing re-treatment may become necessary, depending on the presence of fleas in the environment. In these cases do not re-treat more frequently than once weekly.

In cases of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Method of administration:

Apply only to undamaged skin. Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette. Snap back the tip. With the dog in the standing position, part the coat between the shoulder blades until the skin is visible.

Place the tip of the pipette on the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot. Temporary changes to the coat (clumped/greasy hair) may be noted at the application site.

Correct application will minimise the opportunity for the animal to lick the product.

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

No adverse clinical signs were produced by either individual doses of up to 200 mg/kg body weight (five to eight times the therapeutic dose), daily treatments at 100 mg/kg body weight for five consecutive days or weekly treatments at five times the maximum dose rate for eight consecutive weeks.

In rare cases of overdose or licking of treated fur, nervous system disorders (such as twitching, tremors, ataxia, mydriasis, miosis, lethargy) can occur.

Poisoning following inadvertent oral uptake in animals is unlikely. In this event, treatment should be symptomatic under veterinary medical attention. There is no known specific antidote but administration of activated charcoal may be beneficial.

4.11 Withdrawal period(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use; Imidacloprid ATCvet code: QP53AX17

5.1 Pharmacodynamic properties

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to a group of chloronicotinyl compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.

The substance has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS). The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptor sites and the postulated poor penetration through the blood/brain barrier in mammals, it has virtually no effect on the mammalian CNS. The minimal pharmacological activity in mammals is supported by safety studies involving systemic administration of sublethal doses to rabbits, mice and rats.

In further studies, in addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the pet’s surroundings are killed following contact with a treated animal.

5.2 Pharmacokinetic particulars

The product is indicated for cutaneous administration. Following topical application in dogs, the solution is quickly distributed over the animal. Acute dermal studies in the rat and target animal overdose and serum kinetic studies have established that systemic absorption is very low, transient and not relevant for the clinical efficacy. This has been further demonstrated by a study in which fleas were not killed after having fed on previously treated animals once the animal’s skin and fur had been cleaned of all active material.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxytoluene (E 321)

Benzyl alcohol (E 1519) Propylene carbonate 6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

6.4 Special precautions for storage

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

6.5 Nature and composition of immediate packaging

A white pipette composed of a heat-formed shell of composed of a polypropylene/cyclic olefin copolymer/polypropylene layer and a polyethylene/ethylene vinyl alcohol/polyethylene layer.

Box with 1, 2, 3, 4, 6 pipettes in individual foil sachets. Not all pack sizes may be marketed.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Imidacloprid may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.

7. MARKETING AUTHORISATION HOLDER

EU Pharmaceuticals Ltd.

37 Geraldine Road

London

SW18 2NR

8. MARKETING AUTHORISATION NUMBER

Vm 39787/4078

9. DATE OF FIRST AUTHORISATION

3 July 2019

10. DATE OF REVISION OF THE TEXT

3 July 2019

Approved 3 July 2019