Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Florfenicol
Krka d.d., Novo Mesto
QJ01BA90
Florfenicol
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antimicrobial
Authorized
2007-07-04
Revised: September 2015 AN: 01292/2014 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fenflor 300 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Florfenicol 300 mg EXCIPIENTS: For the 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. Treatment and metaphylaxis of respiratory tract infections in cattle due to _Mannheimia haemolytica, Pasteurella multocida _and_ Histophilus somni_, where the presence of the disease in the herd has been established. 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. Do not use in case of resistance to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: September 2015 AN: 01292/2014 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE 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. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and may decrease the effectiveness of treatment with other amfenicols, due to the potential for cross resistance. Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Do not use the product in known cases of sensitivity to propylene glycol. 4.6 A Read the complete document