Dosage and Administration
The recommended minimum doses for cats are 10 mg/kg body weight imidacloprid and 1.0 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for cats.
Dosage schedule for ferrets: one pipette of Advocate spot-on solution for small cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose.
The recommended minimum doses for dogs are 10 mg/kg body weight imidacloprid and 2.5 mg/kg body weight moxidectin, equivalent to 0.1ml/kg body weight Advocate for dogs.
The treatment schedule for all species should be based on individual veterinary diagnosis and on the local epidemiological situation.
Flea Treatment and Prevention (Ctenocephalides felis)
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of Ear Mite Infestation (Otodectes cynotis)
A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canal at each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of Biting Lice (Trichodectes canis)
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Treatment of Sarcoptic Mange (caused by Sarcoptes scabiei var. canis)
A single dose should be administered twice 4 weeks apart.
Treatment of Eucoleus (syn. Capillaria) boehmi (Adults)
The product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.
Treatment of the eye worm Thelazia callipaeda (adults)
A single dose of the product should be administered.
Treatment of Demodicosis (caused by Demodex canis)
The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Prevention of Heartworm Disease (D.immitis)
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with Advocate, the advice provided in Contra-Indications and Warnings etc should be considered. For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis larvae) are present. The product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of animals having heartworm. Therefore, they can be treated without special precautions.
Prevention of Cutaneous Dirofilariasis (Skin Worm) (D. repens)
For prevention of cutaneous dirofilariasis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month.
Treatment of Microfilariae (D. immitis)
Advocate should be administered monthly for two consecutive months.
Treatment of Cutaneous Dirofilariosis (Skin Worm) (adult stages of Dirofilaria repens)
Advocate should be administered monthly for six consecutive months.
Reduction of Microfilariae (Skin Worm) (D. repens)
The product should be administered monthly for four consecutive months.
Roundworm, Hookworm and Whipworm Treatment (Toxocara Canis, Ancylostoma Caninum, Uncinaria Stenocephala, Toxascaris Leonina and Trichuris Vulpis)
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes. Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
Treatment and Prevention of Angiostrongylus Vasorum
A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
In endemic areas regular four weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.
Treatment of Crenosoma Vulpis
A single dose should be administered
Prevention of Spirocercosis Spirocerca Lupi
The product should be administered monthly.
Method of administration
For external use only.
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette.
For Dogs up to 25kg
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
For Dogs of more than 25 Kg
For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal's side.
Use During Pregnancy and Lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. Therefore, the use of the product is not recommended in animals intended for breeding or during pregnancy and lactation.
Contra-Indications, Warnings, etc
Do not use in puppies under 7 weeks of age.
Treatment of dogs weighing less than 1 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 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 the 'Method of Application' section, 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 the 'Method of Application' section), 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 the 'Method of Application' section; 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. If the animal licks the application site after treatment, neurological signs (most of which are transient) may be observed in very rare cases (see below). 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.
The product was administered to 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.
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 microfilaremia 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.
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.