Colistin sulphate 200 mg /ml.
1 ml of Colidem contains:
Colistin sulphate (active substance) 200 mg
Pigs and chickens.
In pigs and chickens: for treatment and metaphylaxis of enteric infections caused by non-invasive E. coli susceptible to colistin. The presence of the disease in the herd should be established before metaphylactic treatment.
In chickens and pigs the product is administered via drinking water at dosage of 0,01 – 0,025 ml Colidem (approx. 38.000 IU – 95.000 IU colistin sulphate)/kg bw/day, for 3-5 consecutive days.
Treatment duration should not exceed 7 days.
Duration of treatment should be limited to the minimum time necessary for the treatment of the disease. The uptake of medicated water is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
- Side effects
- Correct administration
- Withdrawal period
- Other information
Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients.
Do not use in horses, particularly in foals, since colistin, due to a shift in the gastrointestinal microflora balance could lead to the development of antimicrobial associated colitis (Colitis X), typically associated with Clostridium difficile, which may be fatal.
Special precautions for storage
Keep away from reach and sight of children!
The product should be stored in original packaging at temperature below 25oC, protected from direct sunlight and frost.
Shelf-life after first opening of package: 28 days. Close tight the recipient after every use. Shelf life after dilution in drinking water, according to directions: 24 hours.
Do not use after expiry date which is stated on the label.
Advice on correct administration
During treatment, the animals should drink only medicated water. Fresh medicated water should be prepared every 24 hours.
Meat and offal: 2 days.
Eggs: zero days.
Special warnings for each target species
Colistin exerts concentration-dependent activity against Gram-negative bacteria. Following oral administration high concentrations are achieved in the gastrointestinal tract, i.e. the target site, due to the poor absorption of the substance. These factors indicate that a longer duration of treatment than the one indicated, leading to unnecessary exposure, is not recommended.
Special precautions for use
Special precautions for use in animals
Do not use colistin as a substitute for good management practices. Colistin is a last resort drug in human medicine for treatment of infections caused by certain multi-drug resistant bacteria. In order to minimise any potential risk associated with widespread use of colistin, its use should be limited to treatment or treatment and metaphylaxis of diseases, and should not be used for prophylaxis. Whenever possible, colistin should only be used based on susceptibility testing. Use of the product deviating from the instructions given may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.
Special precautions to be taken by the person administering the medicinal product to animals
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. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.
Use during pregnancy, lactation or lay
Following the studies made on laboratory animals, colistin sulphate, administered orally, due to low absorption from digestive tract, has not impaired the reproductive functions nor offsprings evolutions the product can be used safely.
Interactions with other medicinal products
Colistin has synergism with beta-lactams and bacteriostatic antibiotics (tetracyclines, macrolides).
Being an oral veterinary medicinal product that is not absorbed from the gastrointestinal tract, the administration with other medicinal products for oral use containing divalent metal ions (e.g. calcium, iron or magnesium). will be avoided.
Incompatibility with ampicilin.
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.
PE-HD flasks of 100 ml, 500 ml, and 1000 ml closed with self-sealant PE-HD caps.
PE-HD cans of 5 l, 10 l, and 20 l closed with self-sealant PE-HD caps.
Not all pack sizes may be marketed.