Water-soluble powder, powder for pigs and poultry.
MANUFACTURING AUTHORIZATION HOLDER: S.C. Delos Impex ’96 S.R.L., 81, Horia, Closca si Crisan Street,
Otopeni, Ilfov District, Romania, Tel. +0040-372 714 433 Fax: +0040-0372 871 445
NAME OF THE VETERINARY MEDICINAL PRODUCT
COLIDEM 50, water-soluble powder, 500 mg colistin sulphate/gram, powder for pigs and poultry.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 gram of Colidem 50 contains: Colistin sulphate 500 mg (minimum 19500 IU/mg), Excipient (lactose monohydrate) qs ad. 1 g
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 feed at the therapeutically dosage of 2-5 mg colistin sulphate /kg bw/day, equivalent with 4 – 10 mg Colidem 50/kg bw/day, for 3-5 consecutive days.
In poultry: the product is administered in drinking water or feed at the therapeutically dosage of 2-5 mg colistin sulphate /kg bw/day, equivalent with 4 – 10 mg Colidem 50/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 50 should be calculated according to the following formula:
In feed:
In drinking water:
The uptake of medicated feed/water is dependant on the clinical condition of animals.
In order to obtain the correct dosage, the concentration in feed or drinking water may have to be adjusted.
ADVICE ON CORRECT ADMINISTRATION
During treatment, the animals should eat only medicated feed and drink only medicated water. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
WITHDRAWAL PERIOD
Meat and offal (pig, poultry): 3 day from cessation of treatment. For eggs: 1 day from the cessation of treatment.
SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children! Store in original packaging, at temperature bellow 25°C, protected from moisture and direct sunlight. 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: 7 days.
Shelf life after incorporation into meal: 7 days 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 dust 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
July 2012
OTHER INFORMATION
Thermo-sealed PET bags with aluminum insertion, containing 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and PET sacks with aluminum insert of 25kg, 50kg.
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.