CEVAXEL ceftiofur 50 mg/ml
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
19-09-2013
Summary of Product characteristics
(SPC)
19-09-2013
Active ingredient:
ceftiofur sodium salt 50 mg/ml
Available from:
CEVA Animal Health
ATC code:
QJ01DD90
Pharmaceutical form:
Powder and solvent for solution for injection
Therapeutic group:
Ceftiofur
Therapeutic area:
Cattle, Pigs
Authorization date:
2012-02-13
Patient Information leaflet
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A. LABELLING
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PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box containing 1 vial of CEVAXEL 50 mg/ml, 1 g
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAXEL 50 mg/ml, powder and solvent for solution for injection for cattle and pigs.
Ceftiofur (as sodium)
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Ceftiofur (as sodium)
1 g
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
4.
PACKAGE SIZE
1 g
5.
TARGET SPECIES
Cattle and pigs.
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Method and route of administration: read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Meat and offal:
- Cattle: 2 days
- Pigs: 2 days.
Milk: zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
Penicillins and cephalosporins may occasionally cause severe allergic reactions. See package leaflet
for user warnings.
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10.
EXPIRY DATE
EXP:
“Once reconstituted, use by------ (7 days, stored in a refrigerator, 12 hours, stored below 25°C)
Once broached, use by
11.
SPECIAL STORAGE CONDITIONS
Stored in a refrigerator (2 °C- 8°C)
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
Disposal: read package leaflet.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only
T
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Summary of Product characteristics
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevaxel
50 mg/ml powder and solvent for solution for injection for cattle and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_One powder vial of 1 g contains: _
Active substance:
Ceftiofur (as sodium).......................................................................................1 g
_One powder vial of 4 g contains: _
Active substance:
Ceftiofur (as sodium).......................................................................................4 g
_One ml solvent contains _
Water for injections ....................................................................................... 1 ml
_1 ml of reconstituted solution contains: _
Active substance:
Ceftiofur (as sodium).................................................................................. 50 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: white to off white powder.
Solvent: clear and colourless liquid.
Reconstituted solution: clear brownish yellow to yellow coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
- For the treatment of bacterial respiratory disease associated with _Pasteurella multocida _and_ _
_Mannheimia haemolytica _sensitive_ to _ceftiofur_. _
- For the treatment of cattle with interdigital necrobacillosis (foot rot) in which _Fusobacterium _
_necrophorum _and _Bacteroides melaninogenicus (Porphyromonas asaccharolytica) _sensitive to
ceftiofur_ _are_ _involved.
PIGS:
- For the treatment of bacterial respiratory disease i
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