国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Florfenicol
Dopharma Research B.V.
QJ01BA90
Florfenicol
300 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
florfenicol
Antibacterial
Authorised
2014-03-28
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Flordofen 300 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: _ _ ACTIVE SUBSTANCE: Florfenicol 300 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _ QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT N-methyl pyrrolidone 250 mg Propylene glycol Macrogol 300 Clear, slightly yellowish solution 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle and pigs 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES CATTLE: Treatment and metaphylaxis of respiratory tract infections in cattle due to _ Mannheimia haemolytica, _ _Pasteurella multocida_ and _ Histophilus somni_, susceptible to florfenicol. The presence of the disease in the herd should be established before methaphylaxis. PIGS: Treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus _ _pleuropneumoniae _ and _ Pasteurella multocida_ susceptible to florfenicol. 3.3 CONTRAINDICATIONS Do not use in adult bulls and boars intended for breeding purposes. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS This veterinary medicinal product does not contain an antimicrobial preservative. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Do not administer to piglets of less than 2 kg. Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and may de 阅读完整的文件