Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
CEFTIOFUR
Ceva Santé Animale
QJ01DD90
CEFTIOFUR
50 Mg/Ml
Suspension for Injection
POM
Bovine, Porcine
Ceftiofur
Antibacterial
Authorised
2011-04-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cevaxel-RTU 50 mg/ml, suspension for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ceftiofur (as hydrochloride) 50 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Oily beige suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections associated with bacteria sensitive to ceftiofur. IN CATTLE: For the treatment of bacterial respiratory disease associated with _Pasteurella multocida, Mannheimia haemolytica _and _Histophilus somi_. For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with _Fusobacterium_ _necrophorum _and _Bacteroides melaninogenicus _(_Porphyromonas asaccharolytica_). For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with _Escherichia coli_, _Arcanobacterium pyogenes _and _Fusobacterium necrophorum_: this indication is restricted to cases where treatment with another antimicrobial has failed. IN PIGS: For the treatment of bacterial respiratory disease associated with _Pasteurella multocida_, _Actinobacillus_ _pleuropneumoniae _and _Streptococcus suis_. 4.3 CONTRAINDICATIONS Do not administer to an animal previously found to be hypersensitive to ceftiofur and other -lactam antibiotics. Do not inject intravenously. Do not use where resistance to other cephalosporins or beta-lactam antibiotics has occured. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. HEALTH PRODUCTS REGULATORY AUTHORITY ____________________ Prečítajte si celý dokument