Selehold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg. Clear colourless to yellow spot on solution.

Selehold 45 mg spot-on solution for cats 2.6–7.5 kg. Clear colourless to yellow spot on solution.

Selehold 30 mg spot-on solution for dogs 2.6–5.0 kg. Clear colourless to yellow spot on solution.

Selehold 60 mg spot-on solution for dogs 5.1–10.0 kg. Clear colourless to yellow spot on solution.

Selehold 120 mg spot-on solution for dogs 10.1–20.0 kg. Clear colourless to yellow spot on solution.

Selehold 240 mg spot-on solution for dogs 20.1–40.0 kg. Clear colourless to yellow spot on solution.

caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. 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 in areas to which the animal has access.

caused by Dirofilaria immitis with monthly administration. 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 dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when the product has been administered monthly. This product is not effective against adult D. immitis.

For spot-on use. Apply to the skin at the base of the neck in front of the shoulder blades.

1. Remove the pipette from its packaging. Hold the pipette in an upright position, twist and pull the cap off. 2. Turn the cap around and place the other end of the cap back on the pipette. Push and twist the cap to break the seal, then remove the cap from the pipette. 3. Part the coat on the back of the animal at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the pipette onto the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot. Avoid contact between the product and your fingers.

The product should be administered as a single application of a single dose delivering a minimum of 6 mg/kg selamectin. 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.

Following administration of the veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product should be administered at monthly intervals.

The veterinary medicinal 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 veterinary medicinal product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms. When replacing another heartworm preventive veterinary medicinal product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.

Treatment of roundworm infections (cats and dogs) Single dose of veterinary medicinal product.

Treatment of biting lice (cats and dogs) Single dose of veterinary medicinal product.

Treatment of ear mites (cats) Single dose of veterinary medicinal product.

Treatment of ear mites (dogs) A single dose of the veterinary medicinal product should be administered. Loose 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 hookworm infections (cats) Single dose of the veterinary medicinal product

Treatment of sarcoptic mange (dogs) For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.

Use during pregnancy and lactation: Selamectin can be used in breeding, pregnant and lactating cats and dogs.

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.

Animals may be bathed 2 hours after treatment without loss of efficacy.

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.

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.

User safety: This 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 product. Wash hands after use and wash off any 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. 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. Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.

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): Use of the veterinary medicinal product in cats has on rare occasions been associated with a mild transient alopecia at the site of application. On very rare occasions transient focal irritation may also be observed. The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances. Very rarely, as with other macrocyclic lactones, reversible neurological signs, including seizures, have been observed after use of the veterinary medicinal product in both dogs and cats.

Environmental safety: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Major incompatibilities - none known.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Store in the original package in order to protect from moisture and light. This veterinary medicinal product does not require any special temperature storage conditions.

Translucent polypropylene single dose pipette with lid inserted into aluminium laminated pouch. 15 pouches in a cardboard box.

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones.

ATC vet code: QP54AA05.

Selamectin is a semi-synthetic compound of the avermectin class. Selamectin paralyses and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission. This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods leading to their paralysis and/or death.

Selamectin has adulticidal, ovicidal and larvicidal activity against fleas. Therefore, it effectively breaks the flea life cycle by killing adults (on the animal), preventing the hatching of eggs (on the animal and in its environment) and by killing larvae (environment only). Debris from selamectin-treated pets kills flea eggs and larvae not previously exposed to selamectin and thus may aid in the control of existing environmental flea infestations in areas to which the animal has access.

Activity has also been demonstrated against heartworm larvae.

Following spot on administration selamectin is absorbed from the skin reaching maximum plasma concentrations approximately 5 and 4 days after administration in cats and dogs, respectively. Following absorption from the skin selamectin distributes systemically and is slowly eliminated from plasma as manifested in detectable plasma concentrations in dogs and cats 30 days after administration of a single topical dose at 6 mg/kg. The prolonged persistence and slow elimination of selamectin from plasma is reflected in the terminal elimination half-life values of 8 and 9 days in cats and dogs respectively. The systemic persistence of selamectin in plasma and the lack of extensive metabolism provide effective concentrations of selamectin for the duration of the inter-dosing interval (30 days).

Isopropyl alcohol

Butylhydroxytoluene (E321)

Dimethyl sulfoxide

Selehold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Vm 01656/4134

Selehold 45 mg spot-on solution for cats 2.6–7.5 kg Vm 01656/4135

Selehold 30 mg spot-on solution for dogs 2.6–5.0 kg Vm 01656/4137

Selehold 60 mg spot-on solution for dogs 5.1–10.0 kg Vm 01656/4138

Selehold 120 mg spot-on solution for dogs 10.1–20.0 kg Vm 01656/4139

Selehold 240 mg spot-on solution for dogs 20.1–40.0 kg Vm 01656/4140