EFICUR 50 mg/ml suspension for injection for pigs and cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ceftiofur hydrochloride

Available from:

Laboratorios Hipra S.A.

ATC code:

QJ01DD90

INN (International Name):

Ceftiofur hydrochloride

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

ceftiofur

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2007-05-28

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2019
CRN0094NJ
Page 1 of 6
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 β-lactam antibiotics.
Do not inject intravenously.
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
20 June 2019
CRN0094NJ
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Shake the bottle well before use to bring the product back into
suspension.
In case of the occurrence of allergic reaction the treatment should be
withdraw