Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CEFTIOFUR SODIUM
Norbrook Laboratories Limited
QJ01DD90
CEFTIOFUR SODIUM
50 Mg/Ml
Pdr for Soln for Injection
POM
Bovine, Porcine
Ceftiofur
Antibacterial
Authorised
2009-09-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Powder vial contains: ACTIVE SUBSTANCE Ceftiofur (as ceftiofur sodium) 1g Or Ceftiofur (as ceftiofur sodium) 4g Solvent contains: Water for Injection One ml of reconstituted solution contains: ACTIVE SUBSTANCE Ceftiofur (as ceftiofur sodium) 50mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: off white to brown coloured powder. Solvent: clear, colourless, solution. Reconstituted solution: clear solution, free of particulates. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle Treatment of cattle with acute bacterial respiratory disease in which _Mannheimia haemolytica, Pasteurella multocida_ _or Histophilus somni _sensitive to ceftiofur are involved. Treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which _Fusobacterium necrophorum _and _Bacteroides melaninogenicus _are involved. Pigs Treatment of pigs with bacterial respiratory disease in which _Actinobacillus (Haemophilus) pleuropneumoniae,_ _Pasteurella multocida _and/or _Streptococcus suis _sensitive to ceftiofur are involved. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/09/2014_ _CRN 7018524_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use in animals previously found to be hypersensitive to ceftiofur and other b-lactam antibiotics. Do not use in case of known resistance to the active substance. Do not use in cases where resistance to other cephalosporins or beta Leggi il documento completo