Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CEFTIOFUR (AS HYDROCHLORIDE), KETOPROFEN
Virbac S.A.
QJ01DD
CEFTIOFUR (AS HYDROCHLORIDE), KETOPROFEN
50/150
Suspension for Injection
POM
Bovine
Third-generation cephalosporins
Antibacterial
Authorised
2014-08-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Curacef duo, 50 mg/ml / 150 mg/ml, Suspension for Injection for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains ACTIVE SUBSTANCES: Ceftiofur (as hydrochloride) 50.0 mg Ketoprofen 150.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Off - white to pinkish suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bovine respiratory disease (BRD) caused by _Mannheimia haemolytica _and _Pasteurella multocida_ susceptible to ceftiofur and the reduction of associated clinical signs of inflammation or pyrexia. 4.3 CONTRAINDICATIONS Do not use in cases of known resistance to other cephalosporins or beta-lactam antibiotics. Do not use in case of hypersensitivity to ceftiofur and other -lactam antibiotics. Do not use in case of hypersensitivity to ketoprofen. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 12/08/2016_ _CRN 7024198_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL P Lesen Sie das vollständige Dokument