国: ギリシャ
言語: 英語
ソース: HMA (Heads of Medicines Agencies)
colistin sulfate 2000000 IU/ml
CEVA S.A.
QA07AA10
Oral solution
colistin
Chicken, Pigs
2011-09-23
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 完全なドキュメントを読む