Страна: Великобритания
Език: английски
Източник: VMD (Veterinary Medicines Directorate)
Marbofloxacin
Vetoquinol SA
QJ01MA93
Marbofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
1997-02-14
Revised: July 2011 AN: 00298/2011 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL 10% SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Marbofloxacin 10.0g Monothioglycerol 0.1g Metacresol 0.2g Disodium edetate 0.01g For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for Injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle & pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: Indicated in the treatment of respiratory infections caused by susceptible strains of organisms. It is also indicated in the treatment of acute E. coli mastitis. In pigs: Indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms. 4.3 CONTRA-INDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the Page 1 of 5 Revised: July 2011 AN: 00298/2011 treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to fluoroquinolones should avoid using this product. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively. In particular, no lesions of the articular joints are encountered Прочетете целия документ