CEFAVEX 50 mg/ml, suspension for injection for pigs and cattle

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Ceftiofur hydrochloride

זמין מ:

SP Veterinaria, S.A.

קוד ATC:

QJ01DD90

INN (שם בינלאומי):

Ceftiofur hydrochloride

כמות:

50 milligram(s)/millilitre

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Cattle, Pigs

איזור תרפויטי:

ceftiofur

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

2013-05-10

מאפייני מוצר

Health Products Regulatory Authority
18 June 2019
CRN0094DC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CEFAVEX 50 mg/ml, suspension for injection for pigs and cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains:
ACTIVE SUBSTANCE:
Ceftiofur (as hydrochloride) 50.0 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
White to off-white, beige 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 _(previously _Pasteurella haemolytica _
), _ _
_Pasteurella multocida_ and _Histophilus somni_ (previously
_Haemophilus somnus_).
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 _, _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 cases of hypersensitivity to ceftiofur and other
b-lactam antibiotics.
Do not inject intravenously.
Do not use in cases where resistance to other cephalosporins or
beta-lactam antibiotics has occurred.
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial resistance to humans.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
18 June 2019
CRN0094DC
Page 2