CEVAXEL RTU 50 mg/ml Suspension for Injection
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
09-06-2013
Summary of Product characteristics
(SPC)
09-06-2013
Active ingredient:
ceftiofur hydrochloride 50 mg/ml
Available from:
CEVA Sante Animale
ATC code:
QJ01DD90
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Ceftiofur
Therapeutic area:
Cattle, Pigs
Authorization date:
2012-02-13
Patient Information leaflet
1
A. LABELLING
2
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
CARDBOARD BOXES OF 100 & 250 ML
VIALS OF 100 & 250 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevaxel-RTU 50 mg/ml, suspension for injection for cattle and pigs
Ceftiofur
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 vial contains:
Ceftiofur (as hydrochloride)
50 mg/ml
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
PACKAGE SIZE
100 ml
250 ml
5.
TARGET SPECIES
Cattle and pigs.
6.
INDICATION(S)
Read the package leaflet before use and disposal.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle: Subcutaneous use.
Pigs: Intramuscular use.
Read the package leaflet before use and disposal.
3
8.
WITHDRAWAL PERIOD
MEAT & OFFAL:
Pigs: 5 days.
Cattle: 8 days
MILK: 0 hours
9.
SPECIAL WARNING(S), IF NECESSARY
Penicillins and cephalosporins may occasionally cause severe allergic reactions. See package leaflet for
user warnings.
10.
EXPIRY DATE
EXP:
Once broached, use by: ___/___/___
Shelf-life after first opening: 28 days.
11.
SPECIAL STORAGE CONDITIONS
Keep the vial in the outer carton in order to protect from light.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read package leaflet before use and disposal.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only.
To be supplied only on veterinary prescription.
14.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep ou
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Summary of Product characteristics
ANNEX I
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 vial contains:
ACTIVE SUBSTANCE:
Ceftiofur (as hydrochloride)
50 mg/ml
For a 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 _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_: : 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
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