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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ceftiofur

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01DD90

INN (International Name):

Ceftiofur

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2009-09-02

Summary of Product characteristics

Revised: September 2014
AN: 00598/2014
Page 1 of 8
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefenil 50mg/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.
CLINCIAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Revised: September 2014
AN: 00598/2014
Page 2 of 8
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.
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-lactam
antibiotics has occurred.
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.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
The product selects for resistant stra