Šalis: Nyderlandai
kalba: anglų
Šaltinis: HMA (Heads of Medicines Agencies)
enrofloxacin 50 mg/ml
Cyton Biosciences Ltd
QJ01MA90
Solution for injection
Fluoroquinolones
Cattle Young, Dogs, Pigs Food
2011-01-12
Revised: December 2011 AN: 00172/2011 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENROXIL 100 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENT(S): n-butyl alcohol as antimicrobial preservative 30 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow solution practically free from particles. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: Treatment of respiratory and alimentary tract diseases of bacterial or mycoplasmal origin (pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia) and secondary bacterial infections subsequent to viral conditions (e.g. viral pneumonia). Pigs: Treatment of respiratory and alimentary tract diseases of bacterial or mycoplasmal origin (pasteurellosis, mycoplasmosis, coli-bacillosis) and multifactorial diseases such as enzootic pneumonia. 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not use in case of resistance against quinolones. Do not use in case of disturbances in growth of cartilages and/or during injury of locomotory system particularly on functionally loaded joints or due to body weight loaded joints. Do not use in case of hypersensitivity to the active substance, or to any of the excipients. Revised: December 2011 AN: 00172/2011 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Cattle: Not more than 10 ml should be administered at one subcutaneous injection site. Calves: Not more t Perskaitykite visą dokumentą