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

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Ceftiofur hydrochloride

제공처:

Laboratorios Maymó, S.A.

ATC 코드:

QJ01DD90

INN (국제 이름):

Ceftiofur hydrochloride

복용량:

50 milligram(s)/millilitre

약제 형태:

Suspension for injection

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Cattle, Pigs

치료 영역:

ceftiofur

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2013-09-13

제품 특성 요약

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