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Contra-indications, warnings, etc
Contraindications: Do not use in puppies under 7 weeks of age. Do not use in kittens under 9 weeks of age. Do not use in cases of 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 veterinary medicinal 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 the veterinary medicinal product for dogs. Only the product for small cats and ferrets (0.4 ml) should be used. Do not use on canaries.
Special warnings for each target species: 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.
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. Efficacy against adult Dirofilaria repens has not been tested under field conditions.
Special precautions for use in animals: The treatment of animals weighing less than 1 kg and ferrets weighing less than 0.8 kg, should be based on a benefit-risk 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 benefit-risk assessment for these animals. 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. The product should only be applied to undamaged skin.
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, ensure correct administration in particular, prevent 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 over dosage 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 the combination of imidacloprid and moxidectin has not been evaluated when administered on the same day as an adulticide.
Imidacloprid is toxic for birds, especially canaries.
User safety: In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately. Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 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. Avoid contact with skin, eyes or mouth. In case of accidental spillage onto skin, wash off immediately with soap and water. Wash hands thoroughly after use. If skin or eye symptoms persist, seek medical advice immediately and show the package leaflet or label to the physician. Do not eat, drink or smoke during application.
Treated animals should not be handled, especially by children, until the application site is dry. Therefore, it is recommended to apply the product in the evening. Recently treated animals should not be allowed to sleep in the same bed as their owner, especially children.
Other precautions: 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. The product should not enter watercourses 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.
Adverse events: Use of the product may result in transient pruritus in dogs and cats. On rare occasions greasy hair, 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, neurological signs (most of which are transient) may be observed in very rare cases. The product tastes bitter. Salivation may occasionally occur if the animal licks the application area immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimize 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 microfilaremia 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 frequency of adverse reactions is defined using the following convention: very common (more than1 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 in 10,000 animals treated, including isolated reports.
Overdose: Up to 10 times the recommended dose was tolerated in cats and adult dogs with no evidence of adverse effects or undesirable clinical signs. Up to 5 times recommended dose, every 2 weeks for 4-6 treatments, was tolerated in kittens, ferrets and puppies with no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed. Up to 5 times recommended minimum dose applied weekly for 17 weeks in dogs over 6 months, was tolerated with no adverse effects or undesirable clinical signs.