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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Ceftiofur hydrochloride

Pieejams no:

SP Veterinaria, S.A.

ATĶ kods:

QJ01DD90

SNN (starptautisko nepatentēto nosaukumu):

Ceftiofur hydrochloride

Deva:

50 milligram(s)/millilitre

Zāļu forma:

Suspension for injection

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības grupa:

Cattle, Pigs

Ārstniecības joma:

ceftiofur

Ārstēšanas norādes:

Antibacterial

Autorizācija statuss:

Authorised

Autorizācija datums:

2013-05-10

Produkta apraksts

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