Страна: Испания
Язык: английский
Источник: HMA (Heads of Medicines Agencies)
florfenicol 300 mg/ml
Gosmore Ltd
QJ01BA90
Solution for injection
florfenicol
Cattle
2012-03-02
Revised March 2013 AN: 01145/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fenflor 300 mg/ml solution for injection for cattle Florfenicol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Florfenicol 300 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A light yellow to yellow, clear, viscous liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Diseases caused by florfenicol susceptible bacteria. Preventive and therapeutic treatment of respiratory tract infections in cattle due to _Mannheimia haemolytica, Pasteurella multocida _and _Histophilus somni. _ The presence of the disease in the herd should be established before preventive treatment. 4.3 CONTRAINDICATIONS Do not use in adult bulls intended for breeding purposes. Do not use in case of hypersensitivity to the active substance or to any of the excipients. See also section 4.7. Do not use in case of resistance to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised March 2013 AN: 01145/2012 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Swab septum before removing each dose. Use a dry, sterile syringe and needle. The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. ii. Special precautions to be taken by the person Прочитать полный документ