Cefenil RTU 50 mg/ml Suspension for Injection for Pigs and Cattle

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Ceftiofur

Verfügbar ab:

Norbrook Laboratories Limited

ATC-Code:

QJ01DD90

INN (Internationale Bezeichnung):

Ceftiofur

Darreichungsform:

Suspension for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cattle, Pigs

Therapiebereich:

Antimicrobial

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2012-07-06

Fachinformation

Revised: July 2019
AN: 00716/2018
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefenil RTU, 50 mg/ml, Suspension for Injection for Pigs and Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as hydrochloride) 50 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
A white to yellowish coloured oily suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections associated with bacteria sensitive to ceftiofur:
In Pigs:
For the treatment of bacterial respiratory disease associated with
_Pasteurella multocida_,
_Actinobacillus pleuropneumoniae_ and _Streptococcus suis_ .
In Cattle:
For the treatment of bacterial respiratory disease associated with
_Mannheimia _
_haemolytica_, _Pasteurella multocida_ and _Histophilus somni _.
For the treatment of acute interdigital necrobacillosis (panaritium,
foot rot), associated with
_Fusobacterium necrophorum_ and _Porphyromonas asaccharolytica_
(previously _Bacteroides _
_melaninogenicus)_ .
For treatment of the bacterial component of acute post-partum
(puerperal) metritis within
10 days after calving associated with,_ Trueperella pyogenes
(_previously _Arcanobacterium _
_pyogenes_) and _Fusobacterium necrophorum_. . The indication is
restricted to cases where
treatment with another antimicrobial has failed.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to other β-lactam
antibiotics or to any of the excipients.
Do not inject intravenously.
Revised: July 2019
AN: 00716/2018
Page 2 of 7
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial resistance to
humans.
Do not use in cases where resistance to ceftiofur or to other
cephalosporins or β-lactam
antibiotics has occurred.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR U