Oral Solution

Compozition:
1 ml contains:
Colistin sulphate 200 mg (min. 20000 IU/mg)
Excipients up to 1 ml.

 

NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT

MANUFACTURING AUTHORIZATION HOLDER

S.C. Delos Impex ’96 S.R.L. 81, Horia, Closca si Crisan Street, Otopeni, Ilfov District, Romania,  Tel./Fax +0040-372 714 433

NAME OF THE VETERINARY MEDICINAL PRODUCT

COLIDEM, as colistin sulphate 200 mg /ml, oral solution for pigs and poultry.

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

1 ml of Colidem contains: Colistin sulphate 200 mg (minimum 19500 IU/mg), Excipients ad. 1 ml

INDICATIONS

In pigs for treatment of gastrointestinal infections produced by bacteria from Fam. Enterobacteriaceae (Salmonella spp., Escherichia coli, Shigella spp, Citrobactrer spp., Klebsiella, Enterobacter, Hafnia spp., Yersinia spp., Erwinia spp.) and Pseudomonas aeruginosa.

In poultry for treatment of gastrointestinal infections produced by bacteria from Familia Enterobacteriaceae (Salmonella spp., Escherichia coli, Citrobactrer spp., Enterobacter, Hafnia spp.,  Yersinia spp., Erwinia spp.) and Pseudomonas aeruginosa.

CONTRAINDICATIONS

Do not give to animals with known hypersensitivity to polymixines.

ADVERSE REACTIONS

None.

TARGET SPECIES

Pigs and poultry.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

In pigs: the product is administered in drinking water at the therapeutically dosage of 2-5 mg colistin sulphate  /kg bw/day, equivalent to 0,01 – 0,025 ml Colidem /kg bw/day, for 3-5 consecutive days.

In poultry: the product is administered in drinking water at the therapeutically dosage of 2-5 mg colistin sulphate  /kg bw/day, equivalent to 0,01 – 0,025 ml Colidem /kg bw/day, for 3-5 consecutive days. Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of COLIDEM should be calculated according to the following formula:

 

Colidem Formula

The uptake of medicated water is dependent on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.

ADVICE ON CORRECT ADMINISTRATION

During treatment, the animals should drink only medicated water. Fresh medicated water should be prepared every 24 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIOD

For pig and poultry meat and organs: 2 day from cessation of treatment. For eggs: zero days from the cessation of treatment.

SPECIAL PRECAUTIONS FOR STORAGE

Keep away from reach and sight of children! The product should be stored in original packaging at temperature between 15 – 25°C, protected from direct sunlight and moisture. Protect from freezing. Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after dilution in drinking water, according to directions: 24 hours. Shelf-life after first opening of package: 28 days. Close tight the recipient after every use. Do not use after expiry date which is stated on the label.
SPECIAL WARNINGS

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and protective masks should be worn when administering the product. Wash hands and exposed skin after use. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, need immediate medical attention. Whenever possible, the treatments should be based on susceptibility testing of the bacteria isolated from the animal. If this isn’t possible, the treatment should be done as per official and local antimicrobial policies.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

August 2011.

OTHER INFORMATION

PE-HD flasks of 100 ml, 500 ml, and 1000 ml.

PE-HD cans of 5 l, 10 l, and 20 l.

Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.