מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Marbofloxacin
Vetoquinol SA
QJ01MA93
Marbofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
1998-06-25
Revised: June 2011 AN: 00299/2011 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL 2 % SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Marbofloxacin 2.0 % w/v Disodium edetate 0.01 % w/v Thioglycerol 0.05 % w/v Metacresol 0.2 % w/v For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES - Cattle: pre-ruminants up to 100 kg b.w. - Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle and pigs Indicated in the treatment of respiratory infections caused by susceptible strains of organisms. 4.3 CONTRA-INDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None Page 1 of 5 Revised: June 2011 AN: 00299/2011 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 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 5 times the recommended dose in cattle and pigs. In particular no lesions of the articular joints are encountered. Subcutaneous injection is well tolerated. Transitory inflammatory reactions are sometimes observed at the injection site, but without clinical imp קרא את המסמך השלם