Virbacef Sterile Powder for Solution for Injection
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-04-2013
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Active ingredient:
ceftiofur 1000 mg, ceftiofur 4000 mg
Available from:
Virbac S.A.
ATC code:
QJ01DB01
Pharmaceutical form:
Powder for solution for injection
Therapeutic group:
Cefalexin
Therapeutic area:
Cattle, Horses, Pigs
Authorization date:
2012-12-20
Summary of Product characteristics
Revised: February 2010
(ATCVet code amended)
1/5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT_ _
Virbacef Powder for Solution for Injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each vial contains 1 g or 4 g of ceftiofur as ceftiofur sodium.
Reconstituted solution:
Ceftiofur (as ceftiofur sodium) 50 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
Cream to yellowish powder.
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_, _Histophilus somni _or other sensitive bacterial
pathogens of the respiratory tract 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_
are involved.
4.3 CONTRAINDICATIONS
Do not use in animals previously found to be hypersensitive to ceftiofur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Only the 20-ml vial should be used for treating groups of small piglets.
Revised: February 2010
(ATCVet code amended)
2/5
4.5
SPECIAL PRECAUTIONS FOR USE
I.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official, national
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