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Contra-indications, warnings, etc
Do not use in kittens under 9 weeks of age.
Do not use in puppies under 7 weeks of age.
Treatment of cats or dogs weighing less than 1 kg, and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.
Do not use in the cases of hypersensitivity to the active substances or to any of the excipients.
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, the corresponding "Advocate spot-on solution for cat" product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.
For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for small cats and ferrets" (0.4 ml) must be used. The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.
For dogs, the corresponding "Advocate for dog" product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.
Do not use on canaries.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.
Consider carefully the correct application method described in section 4.9, especially that the product should be applied to the site specified in order to minimise the risk for the animal to lick the product.
Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry.
When the product is applied in 3 to 4 separate spots (see section 4.9), specific care should be taken to prevent the animal licking the application sites.
During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.
This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collie or Old English Sheep dogs and related breeds or crossbreeds, to correctly administer the product as described under section 4.9; in particular, oral uptake by Collie or Old English Sheep dogs and related breeds or crossbreeds should be prevented.
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.
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. After accidental oral ingestion (e.g. licking at the site of application) or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.
The use of the product may result in transient pruritus in the animal. Vomiting can occur on rare occasions. In dogs transient local skin sensitivity reactions including increased itching, hair loss, greasy fur and redness at application site have been reported in very rare cases in spontaneous (pharmacovigilance) reports. In cats greasy fur and erythema can occur on rare occasions. These signs disappear without further treatment. The product may, in rare cases cause local hypersensitivity reactions. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.
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).
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. 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.
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.
Up to 10 times the recommended dose was tolerated in 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.
The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4 treatments, and there was no evidence of adverse effects or undesirable clinical signs.
It is recommended that cats and ferrets 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 heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets 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 experimental overdosage studies have shown that 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. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advocate has not been evaluated when administered on the same day as an adulticide.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.
The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.
Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.
A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnoea and dyspnoea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.
Efficacy against adult Dirofilaria repens has not been tested under field conditions.
In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.
Imidacloprid is toxic for birds, especially canaries.
No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
Safety of Advocate when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.
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. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.
The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
User Safety
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
After application do not stroke or groom animals until the application site is dry.
People with a known hypersensitivity to 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 numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.
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 advice immediately and show the package leaflet or the label to the physician.
Environmental Safety
Advocate should not be allowed to enter water courses 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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.