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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ceftiofur

Διαθέσιμο από:

Norbrook Laboratories (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

QJ01DD90

INN (Διεθνής Όνομα):

Ceftiofur

Δοσολογία:

50 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Powder for solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

ceftiofur

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-09-25

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
01 April 2019
CRN008ZL1
Page 1 of 6
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
01 April 2019
CRN008ZL1
Page 2 of 6
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The