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

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Ceftiofur

متاح من:

Norbrook Laboratories Limited

ATC رمز:

QJ01DD90

INN (الاسم الدولي):

Ceftiofur

الشكل الصيدلاني:

Powder and solvent for solution for injection

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cattle, Horses, Pigs

المجال العلاجي:

Antimicrobial

الوضع إذن:

Expired

تاريخ الترخيص:

2012-07-10

خصائص المنتج

Revised September 2017
AN: 01561/2016
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, Pigs
and Horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Powder vial contains:
ACTIVE SUBSTANCE
Ceftiofur (as ceftiofur sodium)
1 g
Or
Ceftiofur (as ceftiofur sodium)
4 g
Excipients qs
1 vial
Solvent contains:
Water for Injection
One ml of reconstituted solution contains:
ACTIVE SUBSTANCE
Ceftiofur (as ceftiofur sodium)
50 mg
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, pigs and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections associated with bacteria sensitive to ceftiofur:
In cattle
Treatment
of
cattle
with
acute
bacterial
respiratory
disease
in
which
_Mannheimia _
_haemolytica, _
_Pasteurella _
_multocida _
_or _
_Histophilus _
_somni _
are
involved.
Treatment of cattle with acute interdigital necrobacillosis (foul in
the foot) in
which
_Fusobacterium _
_necrophorum_
and
_Porphyromonas _
_asaccharolytica _
_(Bacteroides melaninogenicus)_ are involved.
Revised September 2017
AN: 01561/2016
Page 2 of 8
In pigs
Treatment of pigs with bacterial respiratory disease in which _
Actinobacillus _
_(Haemophilus) _
_pleuropneumoniae, _
_Pasteurella _
_multocida_
and/or
_Streptococcus suis_ are involved.
In horses
Treatment
of
horses
with
bacterial
respiratory
disease
in
which
_Streptococcus _spp
including
_Streptococcus _
_zooepidermicus_
and
_Streptococcus equi, Staphylococcus_ spp and/or _Pasteurella_ spp are
involved.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to other
beta-lactam antibiotics or to any of the excipients.
Do not use in known cases of resistance to the active su