Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs

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:

2010-09-03

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 50 mg/ml, suspension for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Ceftiofur (as hydrochloride) 50.0 mg
Excipients
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 and 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
_Pasteurella haemolytica_ (_Mannheimia_ spp.), _Pasteurella _
_multocida_ and _Haemophilus somnus_.
For the treatment of acute interdigital necrobacillosis (panaritium,
foot rot), associated with _Fusobacterium necrophorum_ and
_Bacteroides melaninogenicus_ (_Porphyromonas asaccharolytica_).
For 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 administer to an animal previously found to be hypersensitive
to ceftiofur and other β -lactam antibiotics.
Do not use in case of known resistance to the active substance.
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial resistance to human.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Accidental injection is dangerous.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Shake the bottle well before use to bring the product back into
susp