Alfacef RTU, 50 mg/ml, suspension for injection for cattle and pigs

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Ceftiofur hydrochloride

Disponível em:

Alfasan Nederland B.V

Código ATC:

QJ01DD90

DCI (Denominação Comum Internacional):

Ceftiofur hydrochloride

Dosagem:

50 milligram(s)/millilitre

Forma farmacêutica:

Suspension for injection

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Cattle, Pigs

Área terapêutica:

ceftiofur

Indicações terapêuticas:

Antibacterial

Status de autorização:

Authorised

Data de autorização:

2012-03-02

Características técnicas

Health Products Regulatory Authority
25 June 2019
CRN0094HZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alfacef RTU, 50 mg/ml, suspension for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance: Ceftiofur 50.0 mg (as Ceftiofur hydrochloride)
Excipients:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection. White to off white coloured suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (''weighing up to 125 kg''). Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections associated with bacteria sensitive to ceftiofur:
In pigs:
-Treatment of bacterial respiratory disease associated with
_Pasteurella multocida_, _Actinobacillus pleuropneumoniae _and
_Streptococcus suis_.
This product is not to be used in pigs with a bodyweight more than 125
kg.
In cattle:
-Treatment of bacterial respiratory disease associated with
_Mannheimia haemolytica_, _Pasteurella multocida _and _Histophilus _
_somni (_previously _Haemophilus somnus)_.
-Treatment of acute interdigital necrobacillosis (panaritium, foul in
the foot), associated with _Fusobacterium necrophorum _and
_Bacteroides melaninogenicus _(_Porphyromonas asaccharolytica_).
-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 inject intravenously.
Do not administer to an animal previously found to be hypersensitive
to ceftiofur and other ß-lactam antibiotics or to any of
the excipients.
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
Do not use in case of known resistance to the active substance.
Cross resistance to oth