Země: Itálie
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
enrofloxacin 10 g
Krka d.d.
QJ01MA90
Solution for injection
enrofloxacin
Cattle
2011-10-26
Revised: January 2013 AN: 01156/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enroxil Max 100 mg/ml solution for Injection for Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENTS: Benzyl alcohol (E1519) 20 mg Butyl alcohol 30 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear, yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES _ _ _ CATTLE. _ _ _ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of bovine respiratory disease associated with _Mannheimia _ _haemolytica_, _Pasteurella multocida_, _Histophilus somni_ and _Mycoplasma_ spp. where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice. Treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by _E. coli_, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not administer in case of hypersensitivity to the active substance or to any of the excipients. Revised: January 2013 AN: 01156/2012 Pa Přečtěte si celý dokument