Each single-dose (pipette) delivers:

EVICTO 15 mg for cats and dogs 60 mg/ml solution Selamectin 15 mg

EVICTO 30 mg for dogs 120 mg/ml solution Selamectin 30 mg

EVICTO 45 mg for cats 60 mg/ml solution Selamectin 45 mg

EVICTO 60 mg for cats 60 mg/ml solution Selamectin 60 mg

EVICTO 60 mg for dogs 120 mg/ml solution Selamectin 60 mg

EVICTO 120 mg for dogs 120 mg/ml solution Selamectin 120 mg

EVICTO 240 mg for dogs 120 mg/ml solution Selamectin 240 mg

EVICTO 360 mg for dogs 120 mg/ml solution Selamectin 360 mg

Butylhydroxytoluene

Dipropylene glycol methyl ether

Isopropyl alcohol

Spot-on solution.

Colourless to yellow solution.

Dogs and cats.

• Treatment and prevention of flea infestations 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 week of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and 3 larvicidal action may aid in the control of existing environmental flea infestations in area to which the animal has access.

• Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. The product 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 the product. 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.

• Treatment of ear mites (Otodectes cynotis).

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 in the ear canal.

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.

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.

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.

This product is a skin and eye irritant. 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 product of this type should handle the product with caution.

Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.

Mild transient alopecia at the site of application has been reported rarely after use of the veterinary medicinal product in cats. Transient focal irritation may also be observed very rarely. The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances.

Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder has been reported rarely. This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.

As with other macrocyclic lactones, reversible neurological signs, including seizures, have been very rarely observed after use of the veterinary medicinal product.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

The product can be used in breeding, pregnant and lactating cats and dogs.

None known

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.

Administer in accordance with the following table:

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.

A single dose of the veterinary medicinal product should be administered.

A single dose of the veterinary medicinal product should be administered.

A single dose of the veterinary medicinal product should be administered.

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.

A single dose of the veterinary medicinal product should be administered.

For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.

Spot-on use.

Apply to the skin at the base of the neck in front of the shoulder blades.

Remove the product pipette from its protective package.

Apply the tip of the product pipette directly to the skin without massaging.

Squeeze the pipette firmly to empty the contents in one spot. Avoid contact between the product and your fingers.

No undesirable effects were observed after the administration of 10 times the recommended dose of selamectin.

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.

Not applicable

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 1 and 3 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 11 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).

List of excipients

Butylhydroxytoluene

Dipropylene glycol methyl ether

Isopropyl alcohol

Not applicable.

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

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

This veterinary medicinal product does not require any special temperature storage conditions. Store in the unopened sachet in a dry place to protect from light and moisture.

The product is available in packs of one, four and twenty-four (all pipette sizes). The veterinary medicinal product is in polypropylene single-dose pipettes in an aluminium sachet overwrap.

1 pipette of EVICTO 15 mg for cats and dogs contains 0.25 ml of 60 mg/ml solution

1 pipette of EVICTO 45 mg for cats contains 0.75 ml of 60 mg/ml solution

1 pipette of EVICTO 60 mg for cats contains 1.0 ml of 60 mg/ml solution

1 pipette of EVICTO 30 mg for dogs contains 0.25 ml of 120 mg/ml solution

1 pipette of EVICTO 60 mg for dogs contains 0.5 ml of 120 mg/ml solution

1 pipette of EVICTO 120 mg for dogs contains 1.0 ml of 120 mg/ml solution

1 pipette of EVICTO 240 mg for dogs contains 2.0 ml of 120 mg/ml solution

1 pipette of EVICTO 360 mg for dogs contains 3.0 ml of 120 mg/ml solution.

Not all pack sizes may be marketed.

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

The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.

VIRBAC, 1ère avenue – 2065m – LID, 06516 Carros, France

EVICTO 15 mg for cats and dogs Vm: 05653 / 5005

EVICTO 45 mg for cats Vm: 05653 / 5009

EVICTO 60 mg for cats Vm: 05653 / 5010

EVICTO 30 mg for dogs Vm: 05653 / 5007

EVICTO 60 mg for dogs Vm: 05653 / 5011

EVICTO 120 mg for dogs Vm: 05653 / 5004

EVICTO 240 mg for dogs Vm: 05653 / 5006

EVICTO 360 mg for dogs Vm: 05653 / 5008

19 July 2021

April 2023