Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Krka, d.d., Novo mesto
QJ01MA93
MARBOFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Marbofloxacin
Antibacterial
Authorised
2011-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marfloxin 100 mg/ml solution for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Marbofloxacin 100 mg EXCIPIENTS: Disodium edetate 0.10 mg Monothioglycerol 1 mg Metacresol 2 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, greenish yellow to brownish yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: - treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida, Mannheimia haemolytica _and _Histophilus somni._ - treatment of acute _E.coli _mastitis_._ In pigs: - treatment of Metritis Mastitis Agalactia (MMA) syndrome caused by susceptible strains of organisms. 4.3 CONTRAINDICATIONS Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). Do not administer in animals with known hypersensitivity to fluoroquinolones, or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 21/10/2016_ _CRN 7022043_ _page number: 1_ 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 Read the complete document