Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Krka, d.d., Novo mesto
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine
Enrofloxacin
Antibacterial
Authorised
2008-09-19
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: 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 28/05/2015_ _CRN 7020775_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Normal sterile precautions should be taken. The safety of the product has not been established in calves when administered by the intravenous route and use of this route of administration in calves is therefore not recommended. Official and local antimicrobial policies should be taken into account w Read the complete document