Contraindications:
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).
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species:
Do not apply when the animal’s hair coat is wet. Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the veterinary medicinal product in these cases has not been investigated. 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. Selamectin may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with selamectin. It is also recommended that animals should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when the veterinary medicinal product has been administered monthly. This veterinary medicinal product is not effective against adult D. immitis. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Special precautions for use:
Special precautions for use in animals
This veterinary medicinal product is to be applied to the skin surface only. Do not administer orally or parenterally. Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use and wash off any veterinary medicinal product in contact with the skin immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician. This veterinary medicinal product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition. Do not smoke, eat or drink while handling the veterinary medicinal product.
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. People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Special precautions for the protection of the environment
Selamectin is toxic for aquatic organisms. Treated dogs should not be allowed to enter surface water for 48 hours after treatment, to avoid adverse effects on aquatic organisms.
Interactions:
In extensive field testing no interactions between selamectin and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Adverse reactions (frequency and seriousness):
Cats
Rare (1 to 10 animals / 10,000 animals treated): Application site alopecia1,2, Application site hair changes3, Hypersalivation6
Very rare (<1 animal / 10,000 animals treated, including isolated reports): Application site irritation (focal)2,4 Neurological signs (including seizures)5
Dogs
Rare (1 to 10 animals / 10,000 animals treated): Application site hair changes3
Very rare (1 animal / 10,000 animals treated, including isolated reports): Neurological signs (including seizures)5
1 Mild and transient.
2 Normally self-resolving, but symptomatic therapy may be applicable in some circumstances
3 Local 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.
4 Transient and focal.
5 Reversible as with other macrocyclic lactones.
6 If significant licking occurs, a brief period may be observed.
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 the national competent authority via the national reporting system. See the package leaflet for contact details.
Use during pregnancy, lactation or lay:
Pregnancy and lactation: Can be used during pregnancy and lactation.
Fertility: Can be used in breeding cats and dogs. 4.8 Interaction with other medicinal products and other forms of interaction In extensive field testing no interactions between selamectin and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
No undesirable effects were observed after the administration of 10 times the recommended dose. Selamectin was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed. Selamectin was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive Collies, and no undesirable effects were observed.
Interaction with other medicinal products and other forms of interaction:
In extensive field testing no interactions between selamectin and routinely used veterinary medicinal products or medical or surgical procedures were observed.