Cevaxel-RTU 50 mg/ml, Suspension for Injection for Cattle and Pigs

Summary of Product characteristics

                                Revised: September 2022
AN: 01486/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevaxel-RTU 50 mg/ml, Suspension for Injection for Cattle and Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as hydrochloride)
50 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Oily beige suspension for injection
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 CATTLE:
For the treatment of bacterial respiratory disease associated with
_Pasteurella multocida, _
_Mannheimia haemolytica _and _Histophilus somi_.
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_: : this indication is restricted to cases
where treatment with
another antimicrobial has failed.
IN PIGS:
For the treatment of bacterial respiratory disease associated with
_Pasteurella multocida_,
_Actinobacillus pleuropneumoniae _and _Streptococcus suis_.
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 where resistance to other cephalosporins or beta-lactam
antibiotics has
occured.
Revised: September 2022
AN: 01486/2022
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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 known.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use as prophylaxis in case of retained placenta.
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