Cefokel 50 mg/ml, Suspension for Injection for Pigs and Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ceftiofur

Available from:

Kela – Kempisch Laboratorium – Kela Laboratoria NV

ATC code:

QJ01DD90

INN (International Name):

Ceftiofur

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2013-05-23

Summary of Product characteristics

Revised: October 2022
AN: 01661/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEFOKEL 50 mg/ml, suspension for injection for pigs and cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains:
ACTIVE SUBSTANCE:
Ceftiofur (as hydrochloride) 50,0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
White to off-white, beige 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:
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_
(previously
_Pasteurella _
_haemolytica_),
_Pasteurella _
_multocida_
and
_Histophilus somni_ (previously _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.
Revised: October 2022
AN: 01661/2022
Page 2 of 8
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ceftiofur and other

-lactam antibiotics.
Do not inject intravenously.
Do not use in cases where resistance to other cephalosporins or

-lactam antibiotics
has occurred.
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
4.5
SPECIAL PRECAUTIONS FOR USE
Special precau