Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
colistin sulfate 0 IU/ml
Cyton Biosciences Ltd
QA07AA10
Oral solution
colistin
Cattle Young, Chicken, Other Young, Pigs
2010-10-28
Revised: December 2010 AN: 00921/2010 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Coliplus 2,000,000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens ES: Colistina Divasa 2,000,000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 1 ml: ACTIVE SUBSTANCE: Colistin (as Colistin sulfate) 2 MIU (equivalent to 83.33 mg) EXCIPIENT(S): Benzyl Alcohol 10 mg Disodium edetate 0.1 mg Excipients qs 1 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for oral solution for use in drinking water. Clear yellow-brown solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves), sheep (lambs), swine and chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of gastrointestinal infections caused by non-invasive _Escherichia coli_ susceptible to colistin. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to polypeptide antibiotics or to any of the excipients. Do not use in case of resistance to the polymyxin. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Use of the product should be based on susceptibility testing and take into account official and local antimicrobials policies. Revised: December 2010 AN: 00921/2010 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Using the veterinary medicinal product (antimicrobials) in poultry should be in accordance with Commission Regulation EC 1177/2006 and Read the complete document