Ceftiocyl Fluid 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:

Vetoquinol Ireland Limited

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 area:

ceftiofur

Authorization status:

Authorised

Authorization date:

2017-12-08

Summary of Product characteristics

Health Products Regulatory Authority
27 September 2019
CRN009282
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ceftiocyl Fluid 50 mg/ml, suspension for injection for pigs and cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE(S):
Ceftiofur (as hydrochloride) 50.0 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Slightly yellow to slightly pink, milky suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs.
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, Pasteurella multocida and
Histophilus somni.
For the treatment of acute interdigital necrobacillosis, (panaritium,
foot rot), associated with Fusobacterium necrophorum and
Bacteroides melaninogenicus.
For treatment of the bacterial component of acute post-partum
(puerperal) metritis within 10 days after calving associated with
Escherichia coli, Trueperella pyogenes (former Arcanobacterium
pyogenes) and Fusobacterium necrophorum, sensitive to
ceftiofur, where treatment with another antimicrobial has failed.
4.3 CONTRAINDICATIONS
Do not inject intravenously.
Do not use in poultry (including eggs) due to the risk of spread of
antimicrobial resistance to humans. Do not use in cases of
hypersensitivity to ceftiofur, to any other β-lactam antibiotics, or
to any of the excipients.
Do not use in cases of known resistance to ceftiofur or other
β-lactam antibiotics.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Health Products Regulatory Authority
27 September 2019
CRN009282
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of the occurrence of allergi