EFICUR 50 MG/ML SUSPENSION FOR INJECTION FOR PIGS AND CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CEFTIOFUR (AS CEFTIOFUR HYDROCHLORIDE)

Available from:

Laboratorios Hipra S.A.

ATC code:

QJ01DD90

INN (International Name):

CEFTIOFUR (AS CEFTIOFUR HYDROCHLORIDE)

Dosage:

50 Mg/Ml

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Porcine

Therapeutic area:

Ceftiofur

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2007-05-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
EFICUR 50 mg/ml suspension for injection for pigs and cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Ceftiofur ........ 50 mg (as Ceftiofur Hydrochloride)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
A white or yellowish oily 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:
Pigs:
- Treatment
of bacterial
respiratory disease associated with_ Pasteurella multocida_,
_Actinobacillus pleuropneumoniae_
and_ Streptococcus suis_.
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 the 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_ (RESTRICTED
TO CASES
WHERE TREATMENT WITH ANOTHER ANTIMICROBIAL HAS FAILED).
4.3 CONTRAINDICATIONS
Do not administer to an animal previously found to be hypersensitive
to ceftiofur and other
-lactam antibiotics.
Do not inject intravenously.
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial resistance to humans.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___