Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Marbofloxacin
Cross Vetpharm Group Ltd
QJ01MA93
Marbofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2016-11-01
Issued: November 2016 AN: 00058/2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbim 100 mg/ml Solution for Injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Marbofloxacin 100 mg EXCIPIENTS: Metacresol 2.0 mg Monothioglycerol 1.0 mg Disodium edetate (E 386) 0.1 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection A clear yellow solution, free of any particulate matter. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs (sows) 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 _Mycoplasma bovis_. Treatment of acute mastitis caused by _E. coli_ strains sensitive to marbofloxacin during the lactation period. In Pigs (sows): Treatment of Metritis Mastitis Agalactia syndrome (postpartum dysgalactia syndrome, PDS) caused by susceptible strains of organisms. 4.3 CONTRAINDICATIONS Do not use for bacterial infections with resistance to other fluoroquinolones (cross resistance). Do not administer in animals with known hypersensitivity to marbofloxacin or any other quinolone or to any of the excipients. Page 1 of 5 Issued: November 2016 AN: 00058/2015 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by gram positive bacteria. 4.5 SPECIAL PRECAUTIONS FOR USE 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 in Read the complete document