COLISTINE CEVA
Country: Austurríki
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
Vara einkenni
(SPC)
22-07-2012
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
colistin sulfate 2000000 IU/ml
Fáanlegur frá:
CEVA S.A.
ATC númer:
QA07AA10
Lyfjaform:
Oral solution
Meðferðarhópur:
colistin
Lækningarsvæði:
Chicken, Pigs
Leyfisdagur:
2011-09-23
Vara einkenni
1/4
Dokument1
July 07
SUMMARY OF PRODUCT CHARACTERISTICS
(S.P.C.)
DAY 90
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
COLISTINE CEVA 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry [France]
COLISCOUR 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry [Ireland]
COLIVET 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry [Austria, Cyprus, Greece,
Portugal, Spain]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
- Colistin (as sulphate) .............................................................2 000 000 IU
EXCIPIENTS:
- Benzyl alcohol ................................................................................ 10 mg
- Excipients ...................................... q.s. .............................................1 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and poultry.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections of the gastrointestinal tract caused by _Escherichia coli_ and _Salmonella_
susceptible to colistin.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to polypeptide antibiotics or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
2/
4
Dokument1
July. 07
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT
TO ANIMALS
People with known hypersensitivity to polymyxins should avoid contact with the veterinary
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