Do not use in animals under 6 weeks of age.
Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
This veterinary medicinal product is to be applied to the skin surface only. Do not administer orally or parenterally.
Do not apply when the animal’s hair coat is wet. However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
For ear mite treatment, do not apply directly to the ear canal.
It is important to apply the dose as indicated to minimise the quantity that the animal can lick off. If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.
Avoid direct contact with treated animals until the application site is dry. On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children. Used applicators should be disposed of immediately and not left within the sight or reach of children.
Dogs:
Rare (1 to 10 animals / 10,000 animals treated: | application site hair changes1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | neurological signs (including seizures2) |
1Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder which typically disappear within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
2Reversible as with other macrocyclic lactones.
Cats:
Rare (1 to 10 animals / 10,000 animals treated): | application site alopecia1,2, application site hair changes3 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | application site irritation1,4, neurological signs (including seizures5) |
1Normally self-resolving, but symptomatic therapy may be applicable in some circumstances.
2Mild and transient.
3Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder which typically disappear within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
4Transient and focal.
5Reversible as with other macrocyclic lactones.
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 also section "Contact details" of the package leaflet.
User warnings:
Wash hands after use and wash off any product in contact with the skin immediately with soap and water. In case of accidental eye exposure, flush the eyes immediately with water, seek medical advice immediately and show the package leaflet or the label to the physician.
People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Do not smoke, eat or drink while handling the product.