Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
marbofloxacin 100 mg/ml
Miklich Laboratorios S.L
QJ01MA93
Solution for injection
marbofloxacin
Cattle
2011-03-23
Issued: October 2011 AN: 00045/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ubiflox Cattle 100 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Marbofloxacin 100 mg EXCIPIENTS: Disodium edetate 0.10 mg Monothioglycerol 1 mg Metacresol 2 mg For a 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. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of respiratory infections caused by sensitive strains of _Pasteurella _ _multocida_, _Mannheimia haemolytica_ and _Histophilus somni_. 4.3 CONTRAINDICATIONS Do not administer in animals with known hypersensitivity to marbofloxacin or 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). Issued: October 2011 AN: 00045/2010 Page 2 of 5 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 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. Where possible, fluoroquinolones should be used based on suscept Read the complete document