Cemay 50 mg/ml suspension for injection for pigs and cattle

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Ceftiofur hydrochloride

Tillgänglig från:

Laboratorios Maymó, S.A.

ATC-kod:

QJ01DD90

INN (International namn):

Ceftiofur hydrochloride

Dos:

50 milligram(s)/millilitre

Läkemedelsform:

Suspension for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Cattle, Pigs

Terapiområde:

ceftiofur

Terapeutiska indikationer:

Antibacterial

Bemyndigande status:

Authorised

Tillstånd datum:

2013-09-13

Produktens egenskaper

Health Products Regulatory Authority
25 June 2019
CRN0094HZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cemay 50 mg/ml suspension for injection for pigs and cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as ceftiofur hydrochloride)…… 50.0 mg
For the fulllist of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
A white or slightly yellow coloured opaque 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
_Bacteroides melaninogenicus _(_Porphyromonas asaccharolytica_).
-For treatment of the bacterial component of acute post-partum
(puerperal) metritis within 10 days after calving associated
with _Escherichia coli_,_Trueperella pyogenes_ (_Arcanobacterium
pyogenes) _and _Fusobacterium necrophorum_, sensitive to ceftiofur_._
-The indication is restricted to cases where treatment with another
antimicrobial has failed.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to
other beta-lactam antibiotics or to any of the excipients.
Do not inject intravenously.
Do not use in poultry (including eggs) due to risk of spread
antimicrobial resistance to humans.Do not use in cases where
resistance to ceftiofur or to other cephalosporins or beta-lactam
antibiotics has occurred.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Health Products Regulatory Authority
25 June 2019
CRN0094HZ
Page 2 of 5
4.5 S