देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: VMD (Veterinary Medicines Directorate)
Lufenuron
Elanco Europe Ltd
QP53BC01
Lufenuron
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats
Insect Growth Regulator
Authorized
1997-12-24
Revised: October 2020 AN: 00986/2020 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PROGRAM 40 mg Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Lufenuron (INN), 40 mg per syringe (0.4 ml of a 10% suspension) EXCIPIENT: Povidone 12 in an aqueous vehicle. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection White to yellow suspension in a pre-filled single-dose syringe for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and weaned kittens less than 4 kg bodyweight. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is intended for the 6-month long-term prevention and control of flea infestations and the treatment of FAD (flea allergic dermatitis) in cats. The product is effective against the pre-adult stages of the dominant flea species, _ Ctenocephalides _ _felis_ and _C. canis_. 4.3 CONTRAINDICATIONS Do not use in dogs. The excipient Polyvinylpyrrolidone (Povidone) is a potent histamine releasing substance in dogs. A severe reaction may occur in dogs that is not observed in cats. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES If cats have flea infestation at the start of treatment, the use of a flea adulticide is recommended. It is essential that all cats (except for unweaned kittens) living in a household are treated with the product to stop flea infestation. Dogs in the same household should be treated as recommended by the prescribing veterinary surgeon. Revised: October 2020 AN: 00986/2020 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The injection should be carried out under aseptic conditions. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental self-injection, a local reaction may occur. In such circumstances seek medical advice immediately and show the package leaflet or the label to the physician. Avoid contact with skin and eyes. In the even पूरा दस्तावेज़ पढ़ें