CEFENIL 50 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOR CATTLE AND PIGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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Download 제품 특성 요약 (SPC)
09-10-2014

유효 성분:

CEFTIOFUR SODIUM

제공처:

Norbrook Laboratories Limited

ATC 코드:

QJ01DD90

INN (국제 이름):

CEFTIOFUR SODIUM

복용량:

50 Mg/Ml

약제 형태:

Pdr for Soln for Injection

처방전 유형:

POM

치료 그룹:

Bovine, Porcine

치료 영역:

Ceftiofur

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2009-09-25

제품 특성 요약

                                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
                                
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