País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
FLORFENICOL
Krka, d.d., Novo mesto
QJ01BA90
FLORFENICOL
300 Mg/Ml
Solution for Injection
POM
Bovine
Florfenicol
Antibacterial
Authorised
2010-09-03
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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 07/08/2015_ _CRN 7019882_ _page number: 1_ 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 adm Llegiu el document complet