国: オランダ
言語: 英語
ソース: HMA (Heads of Medicines Agencies)
marbofloxacin 100 mg/ml
Ecuphar N.V.
QJ01MA93
Solution for injection
marbofloxacin
Cattle Food, Pigs Food
2013-04-24
Issued: August 2013 AN: 00146/2012 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actimarbo 100 mg/ml Solution for Injection for Cattle and Pigs 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 (E 386) 0.1 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear pale yellow to greenish –brownish yellow aqueous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle & pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: Treatment of respiratory infections caused by susceptible strains of _Pasteurella multocida_, _Mannheimia haemolytica_ and _Histophilus somni_. Treatment of acute mastitis caused by _Escherichia coli_ strains susceptible to marbofloxacin during lactation._ _ In pigs: Treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms. Issued: August 2013 AN: 00146/2012 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to marbofloxacin, or any quinolones, 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 Do not use in case of conf 完全なドキュメントを読む