COMPOSITION
Selafelin 12% Spot-On Solution is a clear, colorless or yellow solution containing 120 mg of Selamectin as the active substance and 0.80 mg butylhydroxytoluene (BHT) (E321) as antioxidant preservative in each ml.
INDICATIONS FOR USE
Selafelin 12% Spot-On Solution, in dogs:
It should not be used in animals less than 6 weeks of age.
•
Treatment and prevention of flea infestations: It is used for the treatment and prevention of flea infestations caused by Ctenocephalides species for one month following a single administration. Its efficacy for 1 month following a single administration is the result of the product’s adulticidal, larvicidal, and ovicidal activity against fleas. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations (by reducing existing fleas on the animal) in areas to which the animal has access.
•
Prevention of heartworm disease: When applied once a month, it is used for the prevention of heartworm disease caused by
Dirofilaria immitis. Selafelin 12% 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 Selafelin 12%. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Selafelin 12% has been administered monthly. This product is not effective against adult
D. immitis.
•
Treatment of ear mites (
Otodectes cynotis).
• Treatment of biting lice infestations (
Trichodectes canis).
• Treatment of sarcoptic mange (caused by
Sarcoptes scabiei)
• Treatment of adult intestinal roundworms (
Toxocara canis).
ADMINISTRATION ROUTES AND AMOUNTS
Selafelin 12% should be administered as a single application of a single dose (minimum 6 mg selamectin / kg body weight). When concurrent infestations or infections in the same animal are to be treated with the veterinary medicinal product, only one application of the recommended 6 mg/kg dose should be administered at any one time. The appropriate length of the treatment period for individual parasites is specified below.
Dosage Table:
| Dog (kg body weight) |
Administered amount (mg) |
Strength (mg/ml) |
Administered volume (applied tube volume, ml) |
| 2.6–5.0 |
30 mg |
120 |
0.25 |
| 5.1–10.0 |
60 mg |
120 |
0.50 |
| 10.1–20.0 |
120 mg |
120 |
1.00 |
| 20.1–40.0 |
240 mg |
120 |
2.00 |
| ≥40.1 |
Appropriate combination of pipettes |
120 |
Appropriate combination of pipettes |
Flea treatment and prevention
Following administration of the product, the adult fleas on the animal are killed, no viable eggs are produced, and larvae (found only in the environment) are also killed. This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
For the prevention of flea infestations, the product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestations in the litter up to seven weeks of age.
For use as part of a treatment strategy for flea allergy dermatitis the product should be administered at monthly intervals.
Prevention of heartworm disease
The product may be administered year-round or at least within one month of the animal’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. The final dose must be given within one month after the last exposure to mosquitoes. If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of the product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms. When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the product must be given within a month of the last dose of the former medication.
Treatment of ear mites
It should be administered as a single dose. Dead skin and other debris should be gently removed from the external ear canal at the time of treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Treatment of biting lice
It should be administered as a single dose.
Treatment of sarcoptic mange
For complete elimination of the mites, a single dose of the product should be administered for two consecutive months.
Treatment of roundworm infections
It should be administered as a single dose.
Method and route of administration:
Spot-on use. Apply to the skin at the base of the neck in front of the shoulder blades.
Administration:
Selafelin 12%, is removed from the protective blister package.
Holding the pipette upright and open it by twisting off the cap.
Part the hair at the base of your animal’s neck in front of the shoulder blades to expose a small area of skin
Apply the tip of the pipette directly to the skin without massaging. Squeeze the pipette firmly to empty the contents onto one spot. Avoid contact of the product with your fingers.
WITHDRAWAL PERIOD(S)
Withdrawal Period: Do not use in animals intended for human consumption.
MARKETING PACKAGING
Selafelin 12% Spot-On Solution is offered for sale in 3 pieces of 0.25 ml, 0.50 ml, 1 ml and 2 ml colorless opaque polypropylene pipettes in blister packs inside cardboard boxes.
The 0.25 ml colorless opaque pipette contains 12% solution. The application delivers 30 mg of Selamectin.
The 0.5 ml colorless opaque pipette contains 12% solution, The application delivers 60 mg of selamectin.
The 1 ml colorless opaque pipette contains 12% solution, The application delivers 120 mg of selamectin.
The 2 ml colorless opaque pipette contains 12% solution, The application delivers 240 mg of selamectin.
