ALFACEF RTU, 50 MG/ML, SUSPENSION FOR INJECTION FOR CATTLE AND PIGS

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

CEFTIOFUR (HYDROCHLORIDE)

זמין מ:

Alfasan Nederland B.V

קוד ATC:

QJ01DD90

INN (שם בינלאומי):

CEFTIOFUR (HYDROCHLORIDE)

כמות:

50 Mg/Ml

טופס פרצבטיות:

Suspension for Injection

סוג מרשם:

POM

קבוצה תרפויטית:

Bovine, Porcine

איזור תרפויטי:

Ceftiofur

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

2012-03-02

מאפייני מוצר

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
-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.
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