Virbac Effipro Duo 268 mg drip solution for dogs 20-40 kg, N4

1. NAME OF THE VETERINARY MEDICINE Efipro Duo 268 mg solution for drops for dogs 20-40 kg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pipette with a volume of 2.68 ml contains: Active substances: fipronil 268 mg pyriproxyfen 80 mg Excipients: qualitative composition of excipients and other ingredients Quantitative composition, if this information is necessary for the reliable use of the veterinary medicinal product Butylated hydroxytoluene (E320) 0.536 mg Butylated hydroxytoluene (E321) 0.268 mg Transparent, colorless or yellowish solution.

3. CLINICAL INFORMATION

3.1. Target animal species Dogs (20-40 kg).

3.2. Indications for use with the specified target animal species for the treatment of dogs infested with fleas (Ctenocephalides spp.) and ticks (Dermacentor reticulatus). Acting insecticidal, the veterinary drug prevents infestation with adult fleas for up to 8 weeks. The continuous acaricidal effect of the veterinary drug on ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus) lasts up to 4 weeks. If a dog is infested with certain tick species (Rhipicephalus sanguineus and Ixodes ricinus), it is impossible to eradicate all ticks within the first 48 hours after the start of treatment. This veterinary drug can be used as part of a treatment strategy for major allergic dermatitis when diagnosed by a veterinarian.

3.3. Contraindications Due to the lack of data, the product should not be used in puppies under 2 months of age and/or weighing less than 2 kg. Do not use in sick (systemic diseases, fever) or recovering animals. Do not use in rabbits, as this may cause side effects or even death. This veterinary medicine is specially designed for dogs. Do not use in cats, as overdose is possible. Do not use in case of hypersensitivity to the active substance or any of the excipients.

3.4. Special warnings When washing animals with shampoo 1 hour before treatment, the effect of the veterinary product on fleas remains unchanged. Dogs should not be washed/immersed in water for two days after instillation of the veterinary product. Immersing the animal in water for one minute once a week reduces the insecticidal effect on fleas for one week, so it is recommended to avoid frequent bathing or shampooing. The veterinary product cannot protect against ingestion by ticks. Ticks will die within the first 24-48 hours if the animal has been previously treated for ticks. This usually happens before they have had time to attach themselves completely, so there is less chance of them becoming infected with tick-borne diseases. Dead ticks will usually break off from the animal and fall out. If some ticks still remain, they can be removed by gently pulling them out. Fleas often infest pet bags, beds and their usual resting places such as carpets and upholstered furniture. In case of heavy infestation and appropriate control measures, such areas should be regularly treated with suitable insecticides and vacuumed. When using a product for the treatment of flea allergy dermatitis, it is recommended to apply it monthly to dogs with allergies and other dogs in the household. All dogs and cats in the household should be treated with an appropriate insecticide for optimal flea control and to protect pets from flea infestation.

3.5. Special precautions for use Special precautions for use in target species Before starting treatment, the animal's weight must be accurately determined. Care must be taken to avoid contact with the animal's eyes. If the product accidentally gets into the eyes, rinse them with water as soon as possible. Wash your hands thoroughly with soap after applying the product.

3.6. Adverse reactions Dogs Very rare (<1 animal out of 10,000 animals treated, including isolated reports) Application site reaction1 (i.e. hair, discolouration, alopecia, pruritus, erythema) Generalized reactions.

4. PHARMACOLOGICAL PROPERTIES

4.1. ATCvet code: QP53AX15.

4.2. Pharmacodynamics Fipronil is an insecticidal and acaricidal substance belonging to the phenylpyrazole group. It acts on the chloride channels associated with gamma-aminobutyric acid (GABA) of parasite cells. By blocking its release, the drug disrupts the transmission of chloride ions through presynaptic and postsynaptic membranes. As a result, the activity of the nervous system becomes uncontrollable, and fleas and ticks die. Fipronil is an insecticidal and acaricidal agent effective against fleas (Ctenocephalides spp.) and ticks (Rhipicephalus spp., Dermacentor spp., Ixodes spp., including Ixodes ricinus) parasitizing on dog fur. Fleas die within 24 hours. Ticks are usually killed within 48 hours of application of fipronil, but if the dog is already infested with certain tick species (Rhipicephalus sanguineus and Ixodes ricinus) when treatment is started, it may not be possible to kill all ticks within the first 48 hours.

4.3. Contraindications Do not use in rabbits as this may cause adverse reactions or even death of the animal. Do not use in case of hypersensitivity to the active substance or any of the excipients.

4.4. Special instructions for use in certain target animal species Immediately after treatment, the effectiveness of the product may be reduced if the animal was washed with shampoo or wet with water. Hands should be washed after treatment.

4.5. Special precautions for use Do not use in puppies under 2 months of age and/or weighing less than 2 kg.

4.6. Adverse reactions Dogs Very rare (<1 animal out of 10,000 treated animals, including isolated reports) Application site reaction1 (i.e. hair, discolouration, alopecia, pruritus, erythema) Generalized reactions.

5. PHARMACEUTICAL DATA

5.1. Major nonconformities None known.

5.2. Shelf life Shelf life of the veterinary product without damage to the original packaging: thermoformed pipetki - 3 years, polypropylene pipetki - 2 years.

5.3. Special storage instructions Store below 30 °C. Store in a dry place. Store in the original packaging.

5.4. Nature and contents of the container Thermoplastic pipetki: white multilayer plastic single-dose pipetki with a volume of 0.67 ml. The inner layers in contact with the veterinary product are made of polycardionitrile methacrylate or polypropylene ethyl. The white or transparent part is made of polypropylene, cyclic olefin and polypropylene. The cartons contain 1, 2, 3, 4, 6, 8, 12, 24, 30, 60 or 90 pipetok. Not all pack sizes may be available.

5.5. Special provisions for the disposal of unused veterinary medicinal products or waste associated with their use. Any unused veterinary medicinal product or waste associated with it must be disposed of in accordance with national requirements.

6. NAME OF VIRBAC REGISTRAR

7. REGISTRATION NUMBER(S) LT/2/09/1833/001-036

8. REGISTRATION DATE Registration date 13/02/2009

9. DATE OF LAST REVISION OF THE SPECIFICATION OF THE VETERINARY MEDICINE 2024-05-28

10. CLASSIFICATION OF VETERINARY MEDICINES DISPENSED WITHOUT A PRESCRIPTION. Detailed information on this veterinary medicinal product can be found in the Union Medicines Database (https://medicines.health.europa.eu/veterinary).