Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
marbofloxacin 100 mg/ml
Animalcare Limited
QJ01MA93
Solution for injection
marbofloxacin
Cattle, Pigs
2012-09-26
Issued: December 2012 AN: 01043/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare 100 mg/ml Solution for Injection for Cattle and Pigs (UK, IE, FR) Odimar 100 mg/ml Solution for Injection for Cattle and Pigs (BE, NL, LU, ES, PT, DE, AT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML CONTAINS: ACTIVE SUBSTANCE: Marbofloxacin 100.0 mg EXCIPIENTS: Metacresol 2.0 mg Monothioglycerol 1.0 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 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, Histophilus somni_ and _Mycoplasma bovis_ Treatment of acute mastitis caused by _E.coli_ strains sensitive to marbofloxacin during the lactation period. In pigs: Issued: December 2012 AN: 01043/2011 Page 2 of 6 Treatment of Metritis Mastitis Agalactia syndrome (postpartum dysgalactiae syndrome, PDS) caused by susceptible strains of organisms. 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). _ _ _ _ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Official and local antimicrobial policies should be t Read the complete document