Do not use in kittens under 9 weeks of age.

Do not use in puppies under 7 weeks of age.

Treatment of animals weighing less than 1 kg should be based on a risk-benefit assessment.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

For cats, ‘Advocate Spot-on Solution for cats’, which contains 10 % imidacloprid and 1.0 % moxidectin, must be used.

For dogs, the ‘Advocate Spot-on Solution for dogs’, which contains 10 % imidacloprid and 2.5 % moxidectin, must be used.

Use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. If the animal licks the application site after treatment, transient neurological signs may be observed infrequently.

The product tastes bitter. 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. Correct application will minimise licking of the application site.

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to groom each other. When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal licking the application sites.

This product contains moxidectin (a macrocyclic lactone), special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/or other animals should be prevented.

It is recommended that cats living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease. Whilst the accuracy of diagnosis of feline heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat aged over 6 months, before beginning prophylactic treatment, as use of the product on cats 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.

Although the 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 product.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit assessment.

During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.

No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Up to 10 times the recommended dose was tolerated in adult dogs and cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens and 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, transient neurological signs such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur infrequently.

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.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose without any adverse effects. However, 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.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

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.

People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example allergy, irritation or tingling).

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

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.

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

Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.