Страна: Франция
Язык: английский
Источник: HMA (Heads of Medicines Agencies)
enrofloxacin 0 mg/ml
Norbrook Laboratories Limited
QJ01MA09
Solution for injection
sparfloxacin
Cattle
2011-12-07
Revised: July 2011 AN: 00150/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Norotril Max 100 mg/ml Solution for Injection for Cattle (all other CMS) Enrotril Max 100 mg/ml Solution for Injection for Cattle (Ireland and Portugal) Enrotril 100 mg/ml Solution for Injection for Cattle (Germany, Italy and Spain) Enrofloxacin N-vet (Sweden) Respytril 100 mg/ml Solution for Injection for Cattle (France) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML CONTAINS: ACTIVE SUBSTANCE Enrofloxacin 100.0 mg EXCIPIENTS Benzyl alcohol (E1519) 20.0 mg butan-1-o1 30.0 mg For 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 Indicated for the 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. Revised: July 2011 AN: 00150/2011 Page 2 of 6 4.3 CONTRAINDICATIONS The product should not be used for prophylaxis Do not use in case of disturbances in growth of cartilage and/or during injury of locomotory system particularly on functionally loaded joints or due to body weight loaded joints. 4.4 Прочитать полный документ