国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Florfenicol
SP Veterinaria, S.A.
QJ01BA90
Florfenicol
300 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
florfenicol
Antibacterial
Authorised
2011-12-21
1. NAME OF THE VETERINARY MEDICINAL PRODUCT MYCOFLOR, 300 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains ACTIVE SUBSTANCE: Florfenicol 300 mg EXCIPIENTS: N-methyl pyrrolidone 200 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection. Clear, light yellow to yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: Treatment of respiratory tract infections due to strains of _ Mannheimia haemolytica, _ _Pasteurella multocida _and _Histophilus somni_ susceptible to florfenicol_. _ Pigs: Treatment of acute outbreaks of swine respiratory disease caused by strains of _Actinobacillus pleuropneumoniae_ and _Pasteurella multocida_ susceptible to florfenicol. 4.3 CONTRAINDICATIONS Do not use in adult bulls and boars intended for breeding purposes. Do not use in piglets of less than 2 kg. Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. Do not administer intravenously. Do not use in known cases of resistance to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. The stopper must be cleaned before removing each dose. Use a dry, sterile syringe and needle. 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 antimicrobials, 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 labe 阅读完整的文件