Advantage 80 spot-on is a flea treatment product that is suitable for the treatment of fleas and flea larvae in cats. The active ingredient in Advantage is imidacloprid. The content of the Advantage pipette can easily be administered on the intact skin in the neck. The existing fleas on the cat are killed within one day after application of the product. Treatment with Advantage protects your cat 3 to 4 weeks against other flea infestations. Advantage is well suited for the treatment of cats with flea allergy.

Tip: Don't forget to treat your house against fleas also. Only 5% of the fleas can be found on your pet. The other 95% reside in the environment. Therefore, it is important to simultaneously treat both all your pets and you house itself to deal with the flea infestation. Your house can be treated best by the combination of vacuuming and the use of a spray.

Company name: Bayer plc

Address: Animal Health Division

Bayer House, Strawberry Hill,

Newbury

Berkshire RG14 1JA

Telephone: 01635 563000

Fax: 01635 563622

Email: [email protected] Website: www.bayer.co.uk/products/animalhealth.html Incorporating the data sheets for the following products:

Advantage 40 for Dogs

Advantage 100 for Dogs

Advantage 250 for Dogs

Advantage 400 for Dogs

Advantage 40 for Cats

Advantage 80 for Cats

Advantage for Small Cats, Small Dogs and Pet Rabbits

Advantage for Large Cats and Pet Rabbits Presentation

A clear yellow to slightly brownish free-flowing non-aqueous solution containing 10 % w/v imidacloprid. The product is presented in a single use plastic tube for cutaneous (spot-on) treatment in dogs, cats and pet rabbits. Each tube contains 0.4 ml (40 mg imidacloprid), 1.0 ml (100 mg imidacloprid), 2.5 ml (250 mg imidacloprid), 4.0 ml (400 mg imidacloprid), 0.4 ml (40 mg imidacloprid), 0.8 ml (80 mg imidacloprid), 0.4 ml (40 mg imidacloprid) and 0.8 ml (80 mg imidacloprid) respectively as listed above. The product also contains 0.1% butylated hydroxytolvene (PhEur) as a preservative.

Uses

For the prevention and treatment of flea infestations on cats and dogs.

For the treatment of flea infestations on pet rabbits.

Fleas are killed within one day following treatment. One treatment prevents further flea infestation on dogs for up to four weeks, 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 flea allergy dermatitis in the cat and the dog. The treatment should be repeated after 4 weeks.

Dosage and administration

Please refer to Table 1

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 developing stages is recommended. In order to reduce further the environmental challenge, it is recommended that all cats, dogs and rabbits in the household are treated.

In recent 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.

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

Method of Administration

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

Administration to the Cat/Rabbit

Part the hair on the pet’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. See Figure 2.

Administration to the Dog

With the dog in the standing position, part the coat between the shoulder blades 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. See Figure 3.

Two tubes: (only for Advantage 400 on dogs weighing 40 kg and greater):

Remove two tubes from the package. Using the techniques described above apply the entire contents of each tube evenly to three or four spots all located at different application sites along the dog's backline from the shoulder to the base of the tail.

Do not apply an excessive amount of solution at any one spot that could cause some of the solution to run off the side of the dog. See Figure 4.

All Species

It is particularly important to apply the dose to an area where it cannot be licked off. Correct application will minimise the opportunity for the animal to lick off the product. Apply only to undamaged skin.

Use During Pregnancy and Lactation

Treatment of nursing bitches and queens controls flea infestation on both the dam and offspring.

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 bitches, queens and does together with their offspring are limited. Evidence so far indicates that no adverse effects are to be expected in these animals.

Contra-indications, warnings, etc

Do not use on rabbits intended for human consumption.

Do not use on pet rabbits of less than 10 weeks of age.

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

Do not allow recently treated animals to groom each other.

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

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 after a short time without treatment.

Operator Safety

Wash hands thoroughly after use.

Wash off any skin contamination with soap and water.

After application do not stroke or groom animals until the application site is dry (typically within an hour or so).

People with known skin sensitivity may be particularly sensitive to the product.

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

Avoid contact between the product and the eyes or mouth.

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.

Do not eat, drink or smoke during application.

Pharmaceutical precautions

Store away from food, drink and animal feeding stuffs.

After use, replace cap on tube.

External packaging and empty tubes may be disposed of with domestic refuse.

Legal category

POM-V (previously POM)

Packaging Quantities

Blister pack, packed into a cardboard box with an instruction leaflet or onto a display card, containing 4 tubes filled as follows

Further information

Imidacloprid is an ectoparasiticide belonging to a group of chloronicotinyl compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.

Imidacloprid 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.

Oral studies in the rat show imidacloprid to be absorbed rapidly from the gastro-intestinal tract. Almost complete absorption (95%) occurs within 48 hours. Peak plasma concentrations are observed within 2.5 hours following administration. Tissue distribution is also rapid with the lowest levels recorded in the brain. The active ingredient undergoes extensive metabolism with only 10-16% remaining as parent compound. Almost complete (96%) elimination occurs within 48 hours, approximately 75% being removed by the kidneys and 21% with the faeces.

The solution is indicated for cutaneous administration. Following topical application, the product 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 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.

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

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

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

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

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

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

Marketing authorisation number

1. MA Holder Bayer plc

2. MA Holder Bayer AG