COLIN 5 (powder for oral administration)

Powder from white to light brown in colour, with the smell of its constituents.

1 g of the product contains active substance:

- colistin sulfate - 5 000 000 IU.

Excipients: citric acid, sorbitol.

ATC vet classification code QA07 – antimicrobial veterinary medicinal products used in intestinal infections, QA07AA10 – Colistin. 

Colistin is an antibiotic of the polymyxin group, synthesised by the aerobic spore-forming bacillus Bacillus polymyxa. It has a bactericidal effect on Gram-negative bacteria (Salmonella spp., non-invasive E. coli, Pseudomonas spp.) by binding to phospholipids of the cytoplasmic membrane, increasing its permeability for both intra- and extracellular components, which leads to destruction of cell barriers and lysis of the bacterial cell.

Due to its polypeptide structure, colistin is not absorbed through the walls of the digestive tract (under conditions of oral administration). Its content in the blood serum of calves and pigs has not been detected. In the serum of chickens, colistin was detected at a low concentration 6 hours after administration with drinking water.

In contrast to the low concentrations of colistin in blood serum and tissues, high and constant concentrations are always present in various parts of the digestive tract.

Colistin is excreted from the body of animals with faeces.

Calves up to 3 months of age, pigs, poultry (hens, chickens, turkeys): treatment of animals with diseases of the digestive tract (colibacillosis and salmonellosis) caused by microorganisms sensitive to colistin.

- calves up to 3 months of age – with drinking water or milk: 2,0 g of the product per 100 kg body weight (100 000 IU of colistin sulfate per 1 kg body weight) per day (in two administrations) for 3–5 days.

- pigs: 2,0 g of the product per 100 kg body weight (100 000 IU of colistin sulfate per kg body weight) per day, divided into two doses, or 200 g of the product per 1000 L of drinking water (1 000 000 IU of colistin sulfate per L of drinking water), for 3–5 consecutive days.

- poultry (chickens and turkeys): 1,5 g of the product per 100 kg body weight (75 000 IU of colistin sulfate per kg body weight) or 150 g of the product per 1000 L of drinking water (75 000 IU of colistin sulfate per L of drinking water), for 3–5 consecutive days.

To prepare the solution, the required volume of drinking water, preferably warm, is poured into a clean small container and the product is added in small portions with continuous stirring until completely dissolved. The concentrate prepared in this way (ratio: 0,10 kg–0,20 kg of the product in 10 L of drinking water) is immediately added to the required amount of drinking water according to the daily water consumption rate for the respective age groups of poultry and animals. A fresh solution of the product should be prepared every day.

Hypersensitivity to colistin.

Do not administer to horses.

Do not administer concurrently with ampicillin, cephalosporins or aminoglycosides.

Do not administer in cases when resistant strains of the causative agent are detected.

Do not administer to animals with severe hepatic or renal impairment.

Do not administer to ruminants with functionally developed forestomachs.

Do not use for prophylaxis.

At the recommended doses, adverse reactions are not observed.

In individual cases, allergic reactions (skin rash, pruritus and oedema) and digestive disorders (anorexia, vomiting, meteorism, diarrhoea) may occur. If they occur, treatment should be discontinued and desensitising therapy should be instituted.

Use of the product should be based on the results of susceptibility testing of the causative microorganisms to colistin. In human medicine colistin is used for the treatment of patients with infections caused by multi-resistant bacteria. Use of the product not in accordance with the instructions given in this summary of product characteristics may lead to an increase in the number of bacteria resistant to colistin and to a decrease in the effectiveness of treatment with other antimicrobial products due to cross-resistance.

The product is not recommended for use in animals during pregnancy or lactation due to possible neurotoxic effects. Use of the product is allowed only when it is clearly evident that the benefit of treatment outweighs the possible adverse effects.

There are no data on embryotoxic, teratogenic or mutagenic effects of colistin.

Absorption of colistin may be reduced due to an increased content of Ca2+, Fe3+, Mg2+ and unsaturated fatty acids in animal feed.

It is recommended that the interval between administration of another product containing multivalent cations and colistin should be 1–2 hours.

The product is not recommended to be mixed with other medicinal products.

The slaughter of animals for meat and consumption of eggs for food is allowed 7 days after the last administration of the product. Meat and eggs obtained before the specified period should be disposed of or fed to non-productive animals, depending on the opinion of the veterinary surgeon.

Bags made of polyethylene film according to GOST 10354 or other polymer film of 1, 2, 5, 10, 50, 100 and 500 g, 1 kg, and bags of 25 kg.

Polymer containers of 100 and 500 g, 1 kg.

Store in a dry, dark place out of the sight and reach of children at a temperature between 5 and 25 °C.

Shelf life is 3 years.

Shelf life after first opening of the container is 14 days, when the opened container is stored at a temperature from 15 to 25 °C in a dry place protected from light.

Shelf life of the product after dilution in drinking water is 24 hours.