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

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ceftiofur Hydrochloride

Tilgjengelig fra:

Norbrook Laboratories (Ireland) Limited

ATC-kode:

QJ01DD90

INN (International Name):

Ceftiofur Hydrochloride

Dosering :

50 milligram(s)/millilitre

Legemiddelform:

Suspension for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

ceftiofur

Autorisasjon status:

Authorised

Autorisasjon dato:

2012-07-06

Preparatomtale

Health Products Regulatory Authority
15 January 2019
CRN008T9Q
Page 1 of 8
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.
Health Products Regulatory Authority
15 January 2019
CRN008T9Q
Page 2 of 8
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.
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