Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Animalcare Limited
QJ01MA93
MARBOFLOXACIN
20 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Marbofloxacin
Antibacterial
Authorised
2013-01-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare 20 mg/ml solution for injection for cattle and pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML CONTAINS: ACTIVE SUBSTANCE: Marbofloxacin 20.0 mg EXCIPIENTS: Metacresol 2.0 mg Monothioglycerol 0.5 mg Disodium edetate 0.1 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear yellowish solution. 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 Pre-ruminant calves: Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida, Mannheimia haemolytica _and _Mycoplasma bovis_. Pigs: Treatment of respiratory infections caused by sensitive strains of _Actinobacillus pleuropneumoniae_, _Mycoplasma_ _hyopneumoniae _and _Pasteurella multocida._ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to marbofloxacin or to any other quinolone or to any of the excipients. Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/08/2013_ _CRN 7015251_ _page number: 1_ 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 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 Прочитајте комплетан документ