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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 safe use in the target species: 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.
Special precautions for the protection of the environment:
CATS: Not applicable.
DOGS: The veterinary medicinal product should not 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.
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.
Adverse events:
CATS
Rare (1 to 10 animals / 10,000 animals treated): | Vomiting1 Application site greasy fur1, Application site erythema1, Hypersensitivity reaction2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Behavioural disorder (e.g. agitation, lethargy)3 Inappetence3 Neurological signs4 |
Undetermined frequency (cannot be estimated from the available data): | Pruritus5 Hypersalivation6 |
1These signs disappear without further treatment. 2Local. 3Transiently noted and related to sensation at application site. 4Most occur transiently and if animal licks the application site after treatment (see section 3.10). 5In cats, transient. 6Occurs
If the animal licks the application area immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimize licking of the application sites.
DOGS
Common (1 to 10 animals / 100 animals treated):
| Diarrhoea1, Vomiting1 Cough1, Dyspnoea1, Tachypnoea1 Inappetence1, Lethargy1 |
Rare (1 to 10 animals / 10,000 animals treated):
| Vomiting2 Application site greasy fur2, Application site erythema2, Hypersensitivity reaction3 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
| Behavioural disorders (e.g. agitation)4 Inappetence4, Lethargy4 Neurological signs5 |
Undetermined frequency (cannot be estimated from the available data): | Pruritus6 Hypersalivation7 |
1These signs are common in heartworm positive dogs with microfilaraemia. In a case of severe respiratory signs (cough, dyspnoea, tachypnoea) prompt veterinary treatment may be required. 2These signs disappear without further treatment. 3Local. 4Transiently noted and related to sensation at application site. 5Most occur transiently and if animal licks the application site after treatment (see section 3.10). 6Transient. 7Occurs
If the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.
Reporting adverse events:
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Overdose:
CATS: Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs. The combination of imidacloprid and moxidectin was administered to kittens 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.
The combination of imidacloprid and moxidectin 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.
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.
DOGS: Up to 10 times the recommended dose of the combination of imidacloprid and moxidectin 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 combination of imidacloprid and moxidectin 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. There is no known specific antidote. The use of activated charcoal may be beneficial.