NAME OF THE VETERINARY PRODUCT

EFFITIKS 26.8 mg/240 mg instillation solution for very small dogs

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.44 ml pipette contains:

active ingredients:

• fipronil 26.84 mg;
• permethrin 26.84 mg

excipients:

• butylhydroxyanisole (E320) 0.088 mg,
• butylhydroxytoluene (E321) 0.044 mg.

For the full list of excipients, see page 6.1.

DROP FORM INTRODUCTION

Solution for drops. Clear yellow solution.

CLINICAL DATA

Target species(es)

Dogs.

Indications indicating the relevant animal species

For dogs against fleas and/or blood-sucking ticks, when it is necessary to control (prevent feeding) mosquitoes and/or midges. Fleas For the treatment and protection of dogs infested with fleas (Ctenocephalides felis). Fleas on the dog's coat die within 24 hours after treatment. One treatment prevents reinfestation by adult fleas for four weeks. The veterinary product can be used as an integral part of the control strategy for flea allergy dermatitis (FAD) diagnosed by a veterinarian.

Contraindications

Do not use in case of hypersensitivity to the active ingredients or any of the excipients. Do not use in rabbits and cats as this may cause adverse effects or even death of the animal (see also page 4.5 i). Do not use in sick (e.g. with systemic diseases, feverish) or convalescent animals.

Special warnings for certain target species

The veterinary product remains effective even after exposure to sunlight or after the animal has been wet in the rain. Avoid frequent bathing or shampooing of treated dogs, as this may reduce the effectiveness of the veterinary drug.

Side effects (frequency and severity)

In very rare cases, short-term skin reactions (itching, redness, hair loss) and general itching of the whole body occurred at the site of application of the drug. Very rare behavioral changes (hyperactivity, agitation), neurological disorders, muscle tremors, seizures, ataxia and vomiting were observed. Animals may temporarily increase salivation after licking the drug.

Use during pregnancy, lactation or egg laying

In laboratory studies on dogs administered fipronil and permethrin, no teratogenic or embryotoxic effects were observed. The safety of the veterinary drug for pregnant and lactating female dogs has not been established. The use of a veterinary drug in dogs and lactating females is possible only with the permission of a veterinarian and after assessing the benefit/risk ratio.

Dosage and method of administration

For external use only. Drip. Dosage The minimum recommended dose is 6.7 mg fipronil and 60 mg permethrin per 1 kg of body weight.

PHARMACEUTICAL DATA

List of excipients

butylhydroxyanisole (E320), butylhydroxytoluene (E321), benzyl alcohol (E1519), diethylene glycol monoethyl ether.

Shelf life

The shelf life of the veterinary drug, provided that the original packaging is not damaged, is 3 years. Expiry date after opening the original package - use immediately.

Special storage instructions

Store at temperatures up to 30°C. Store the blister pack in a cardboard box to protect the medicine from light.

REGISTRATOR

Virbac 1ère avenue 2065m LID 06516 Carros France