AMFLEE combo 402/361.8mg Oral solution for dogs over 40kg, 3 pcs

Instructions for use for AMFLEE combo 402/361.8mg Oral solution for dogs over 40kg, 3 pcs

Directions for use of the article Amflee combo 402/361.8 mg solution for application for dogs over 40 kg. Indications: Control of flea infestation alone or in combination with tick and/or hairfly infestation in dogs. 1. NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND DES MANUFACTURER: Marketing authorisation holder: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany. Manufacturer (responsible for batch release): KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia. 2. BEZEICHNUNG DES ANIMAL MEDICINAL: AMFLEE combo 402/361.8 mg solution for application to very large dogs. Active ingredients: fipronil and S-methoprene. 3. WIRKSTOFF(E) UND SONSTIGE INGREDIENTS: One 4.02 ml pipette contains: - Active ingredients: fipronil 402 mg, S-methoprene 361.8 mg. - Other ingredients: Butylated hydroxyanisole (E320) 0.80 mg, Butylated hydroxytoluene (E321) 0.40 mg. 4. ANWENDUNGSGEBIET(E): - Control of flea infestation. - Control of tick infestation. - Killing of infestations of hair lice. 5. CONTRA-INDICATIONS: - Do not use on puppies under 8 weeks of age or weighing less than 2 kg. - Do not use on sick animals or those with hypersensitivity to the active ingredients or other ingredients. - Do not use on wounds or damaged skin. - Do not use on cats, ferrets, rabbits or other animal species. 6. SIDE EFFECTS: - Possible side effects include skin reactions at the application site, itching, hair loss, increased salivation, neurological symptoms, vomiting and difficulty breathing. - The frequency of side effects is rare. 7. ZIELTIERART(EN): Dogs over 40 kg. 8. DOSIERUNG FÜR JEDE ANIMAL SPECIES, ART UND DAUER DER APPLICATION: - Topical application to the skin according to the body weight of the dog. - Use a 4.02 ml pipette for dogs over 40 kg. 9. HINWEISE FÜR DIE RICHTIGE APPLICATION: - Carefully open the pipette and apply the contents to the skin in the neck area of the dog. 10. WARTEZEIT(EN): Not applicable. 11. BESONDERE STORAGE INSTRUCTIONS: - Keep medicinal product out of reach of children. - Store below 30°C. 12. BESONDERE WARNINGS: - Avoid contact with eyes and mouth. - Prevent the animal from licking the treated area or coming into contact with other animals. - Dogs should not swim for 48 hours after treatment. - In case of irritation, rinse eyes carefully with water. - Store pipettes in the original packaging before use. 13 BESONDERE precautionary measures FÜR DIE disposal: - Dispose of unused veterinary medicinal products at hazardous waste collection points. - Do not dispose of veterinary medicinal products in waste water. 14. GENEHMIGUNGSDATUM DER PACKAGE INSERT: February 2018. 15. WEITERE INFORMATION: - There are 1 or more pipettes in the folding box. - Read the package leaflet and ask your veterinarian or pharmacist about risks and side effects.