SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Advantage 80 mg feline and bunny Spot-on solution [UK]

Advantage 80 mg Spot-on solution for Large Cats and Large Pet Rabbits [AT, DE, FR, IE, IT]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.8 ml pipette contains:

Active substance:

Imidacloprid 80 mg

Excipient(s):

Butylhydroxytoluene (E 321) 0.8 mg

Benzyl alcohol (E 1519) 665.6 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

Cats and pet rabbits

4.2 Indications for use, specifying the target species

For cats of 4 kg and greater:

Prevention and treatment of flea (Ctenocephalides felis) infestations.

For pet rabbits of 4 kg and greater:

Treatment of flea infestations.

Fleas are killed within one day following treatment. One treatment prevents further flea infestation for three to four weeks on cats and up to one week on pet rabbits. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) in cats, where this has been previously diagnosed by a veterinary surgeon.

4.3 Contraindications

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

Do not use on pet rabbits of less than 10 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

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 reduction in environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developing stages is recommended. In order to reduce further the environmental challenge, it is recommended that all cats and rabbits in the household are treated. Treatment of nursing queens and does controls flea infestations on both dam and offspring.

The product remains effective if the animal becomes wet, for example after exposure to heavy rain. However, re-treatment may become necessary, depending on the presence of fleas in the environment. In these cases do not treat more frequently than once weekly.

4.5 Special precautions for use

i) Special precautions for use in animals

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

Apply only to undamaged skin

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.

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

Do not massage the application site.

This product contains benzyl alcohol and may cause skin sensitisation or transient skin reactions in rare cases (for example, irritation, tingling).

Avoid contact between the product and skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash off any skin contamination with soap and water.

If the product gets into eyes accidentally, the eyes should be thoroughly flushed with water.

If skin or eye irritation persists, obtain medical attention.

If the product is accidentally swallowed, obtain medical attention immediately.

Wash hands thoroughly after use.

After application, do not stroke or groom animals until application site is dry.

People with known hypersensitivity to imidacloprid should avoid contact with the veterinary medicinal product.

iii) Other precautions

The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

4.6 Adverse reactions (frequency and seriousness)

The product is bitter tasting and salivation may occa­sionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disap­pears within some minutes without treatment.

In very rare occasions (less than 1 animal in 10,000 animals, including isolated reports)skin reactions such as hair loss, redness, itching and skin lesions may occur in cats and rabbits. Agitation, excessive salivation and nervous signs such as incoordination, tremors and depression have also been reported but exceptionally in cats.

4.7 Use during pregnancy, lactation or lay

No reproductive toxic effects have been observed in rats and no primary embryotoxic or teratogenic toxic effects have been observed during the studies on rats and rabbits. Studies on pregnant and lactating queens together with their offspring are limited. Evidence so far suggests that no adverse effects are to be expected in these animals.

4.8 Interaction with other medicinal products and other forms of interaction

No incompatibility has been observed between this product at twice the recommended dose and the following commonly used veterinary products: lufenuron, pyrantel and praziquantel (cats). The compatibility of the product was also demonstrated with a wide range of routine treatments under field conditions including vaccination.

4.9 Amounts to be administered and administration route

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

Dosage and Treatment Schedule

Cat/Rabbit (kg bw)	Product	Number of Pipettes	Imidacloprid (mg/kg bw)
≥ 4 kg	Advantage® 80 for Large Cats and Large Pet Rabbits	1 x 0.8 ml	minimum of 10

Method of Administration

Remove one pipette from the package. Hold pipette in an upright position, twist and pull off cap. Use reversed cap to twist and remove seal from pipette.

Administration to the Cat

Part the hair on the cat's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin.

Administration to the Rabbit

Part the hair on the rabbit’s neck at the base of the skull until the skin is visible. Place the tip of the tube on the skin and squeeze firmly several times to empty the contents directly onto the skin.

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

In cats, no adverse clinical signs were produced using doses of five times the therapeutic level weekly for eight consecutive weeks.

In rabbits, no adverse clinical signs were seen using doses of up to 45 mg/kg body weight (4 times the therapeutic level) weekly for 4 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 in cats.

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)

Do not use on rabbits intended for human consumption.

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 sub-lethal 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 cats, 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 Incompatibilities

None known.

6.3 Shelf life

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

5 years

6.4. Special precautions for storage

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

Keep the blister in the outer carton

6.5 Nature and composition of immediate packaging

Pack sizes 0.8 ml solution per pipette

Blister pack containing 2, 3, 4, or 6 unit dose pipettes

Container White polypropylene pipettes with caps

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

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER(S)

Vm 00010/4178

9. DATE OF FIRST AUTHORISATION

07 December 2011

10. DATE OF REVISION OF THE TEXT

October 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

01 November 2016