Dogs

Do not use in puppies under 7 weeks of age.

Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.

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.

For cats, the corresponding “Prinovox for cats” product (0.4 or 0.8 ml), which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Prinovox for dogs. Only “Prinovox for small cats and ferrets” (0.4 ml) must be used.

Do not use on canaries.

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 (see Indications and Amounts to be administered sections).

Efficacy against Dirofilaria. repens has not been tested under field conditions.

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 benefit-risk assessment for these animals.

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 below under Amounts to be administered section, especially that the product should be applied at the base of the skull 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.

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 Amounts to be administered section; in particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

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.

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 this product has not been evaluated when administered on the same day as an adulticide.

Imidacloprid is toxic for birds, especially canaries.

Avoid contact with skin, eyes or mouth. Do not eat, drink or smoke during application.

Ingestion of the product is harmful. In order to prevent children getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately. Wash hands thoroughly after use.

After application, treated animals should not be handled, especially by children, until the application site is dry. This may be ensured by treating animals in the evening. Do not allow recently treated animals to sleep with owners, especially children.

In case of accidental spillage onto skin, wash off immediately with soap and water.

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. In case of accidental ingestion of the product or if skin or eye symptoms persist, seek medical advice immediately and show the package leaflet or label to the physician.

The solvent in the product 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.

Vomiting can occur on rare occasions. Use of the product may result in transient pruritus in dogs. The product may, in rare cases, cause local hypersensitivity reactions. Transient local skin sensitivity reactions including increased itching, hair loss, greasy fur and redness at application site have been reported in very rare cases. These signs disappear without further treatment. In very rare cases, diarrhoea may occur after application of the product. Neurological signs such as ataxia and muscle tremor (most of which are transient) may be observed in very rare cases (see Overdose).

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 sites.

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.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnea and dyspnea) 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.

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. .

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

Safety of this veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Dosage schedule:

The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight moxidectin, equivalent to 0.1 ml of this product per kg bodyweight.

The treatment schedule should be based on individual veterinary diagnosis and on the local epidemiological situation.

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 the treatment with the product 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.

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

A single dose of the product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. 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.

A single dose should be administered twice 4 weeks apart.

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, the product 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.

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 this product, the advice provided in the Special precautions for use in animals section 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 this product must be given within 1 month of the last dose of the former medication.

In non-endemic areas there should be no risk of dogs having heartworm. Therefore they can be treated without special precautions.

For prevention of cutaneous dirofilariosis, 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.

The product should be administered monthly for two consecutive months.

The product should be administered monthly for six consecutive months.

The product should be administered monthly for four consecutive months.

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 monthly applications will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

A single dose should be administered.

Prevention of Spirocerca lupi:

The product should be administered monthly.

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.

A single dose of the product should be administered.

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.

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.

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.

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.

After accidental oral ingestion 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 occur in very rare cases.

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.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

In case of accidental oral uptake, symptomatic treatment should be administered.

Not applicable