Country: Немачка
Језик: Енглески
Извор: HMA (Heads of Medicines Agencies)
marbofloxacin 20 mg/ml
Animalcare Limited
QJ01MA93
Solution for injection
marbofloxacin
Cattle, Pigs
2012-09-26
Issued: December 2012 AN: 01044/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare 20 mg/ml solution for injection for cattle and pigs (UK, IE, FR) Odimar 20 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 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. Issued: December 2012 AN: 01044/2011 Page 2 of 6 Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). 4.4 SPECIAL WARNINGS 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 condit Прочитајте комплетан документ