Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

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12-06-2017

Ingredientes activos:

Ceftiofur

Disponible desde:

Norbrook Laboratories Limited

Código ATC:

QJ01DD90

Designación común internacional (DCI):

Ceftiofur

Dosis:

50 milligram(s)/millilitre

formulario farmacéutico:

Powder for solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Pigs

Área terapéutica:

ceftiofur

indicaciones terapéuticas:

Antibacterial

Estado de Autorización:

Authorised

Fecha de autorización:

2009-09-25

Ficha técnica

                                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.
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