Cevaxel-RTU 50 mg/ml, suspension for injection for cattle and pigs

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ceftiofur hydrochloride

Διαθέσιμο από:

Ceva Santé Animale

Φαρμακολογική κατηγορία (ATC):

QJ01DD90

INN (Διεθνής Όνομα):

Ceftiofur hydrochloride

Δοσολογία:

50 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Suspension for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle, Pigs

Θεραπευτική περιοχή:

ceftiofur

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-04-21

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
03 July 2019
CRN0095K3
Page 1 of 6
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 ß-lactam antibiotics.
Do not inject intravenously.
Do not use where resistance to other cephalosporins or beta-lactam
antibiotics has occured.
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.
Health Products Regulatory Authority
03 July 2019
CRN0095K3