COLICRID 10%

COMPOSITION

Colistin sulphate 2,000,0000 IU (equivalent to 100 mg)/mL

TARGET SPECIES

Pigs and chickens (broilers).

INDICATIONS

In pigs and chickens (broilers), in the treatment and metaphylaxis of gastrointestinal infections caused by non-invasive E. coli strains susceptible to colistin sulphate. 

Before the metaphylaxis treatment, the presence of the disease in the population should be established.

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substances or to excipients.

Do not use in horses, especially in colts, because colistin, due to alteration of the gastrointestinal microflora balance, could lead to the development of colitis associated with the administration of antimicrobial drugs (colitis X), usually associated with Clostridium difficile, which may be lethal.

ADVERSE REACTIONS

Not known.

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

To ensure a proper dose, the exact body weight will be determined to avoid underdosing or overdosing.

Pigs - 5 mg (100.000 UI) active substance/kg live body weight/day (0.05 mL product) for 5 consecutive days. 

The Colicrid Solution Amount (CSC) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the formula CSC (L) = [5xTBW (kg)/100xTWC (L)] per 1000 L tank water, 5 = dose/kg bw, 100 = mg colistin sulphate/1 mL Colicrid oral solution 

Chickens (broilers) - Administer a dose of 3.75 mg (75,000 UI)/active substance/kg live body weight/day (0.0375 mL produs), for 5 consecutive days. The Colicrid Solution Amount (CSC) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the formula CSC (L) = [3.75xTBW (kg)/100xTWC (L)] per 1000 L tank water, 3.75 = dose/kg bw, 100 = mg colistin sulphate/1 mL Colicrid oral solution The consumption of medicated water depends on the clinical condition of the animals. 

In order to obtain a correct dose, the colistin concentration should be adjusted accordingly. In both species, administration is by oral route in drinking water.

To avoid underdosing or overdosing, the weight of the animals will be accurately estimated. 

In case of group treatment, the animals will be batched according to their average weight.

The duration of treatment should be limited to the minimum time required to treat the disease. The duration of treatment should not exceed 7 days.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The product should be diluted before use in animals. Water consumption should be monitored to ensure adequate dose. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the Colicrid 10% concentration should be adjusted so that the animals assimilate the recommended dose.

WITHDRAWAL PERIOD(S)

Meat and offal:

Pigs - 1 day

Chickens (broilers) - 1 day

Use in poultry laying eggs for human consumption is not authorised.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days. Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

Colistin exerts a concentration-dependent action against Gram-negative bacteria. Oral administration results in high concentrations in the gastrointestinal tract, i.e., the target site, due to insufficient absorption of the substance. These factors indicate that a longer treatment duration than that indicated under point 4.9 of the SmPC is not recommended, leading to unnecessary exposure.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Do not use colistin as a substitute for good management practices. Colistin is a state-of-the-art human medicine for the treatment of infections caused by certain multi-resistant bacteria. To minimize any potential risk associated with the widespread use of colistin, its use should be restricted to the treatment and metaphylaxis of diseases and should not be used for prophylaxis. Wherever possible, colistin should only be used on the basis of susceptibility testing. Using the product without following the instructions in the SmPC may lead to treatment failure and an increase in the prevalence of colistin-resistant bacteria.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Colistin may cause irritation. It may cause allergies following inhalation, accidental ingestion or accidental contact with skin or eyes. Those with known sensitivity to polymyxins or excipients will avoid contact with the product.

To avoid exposure during medicated solution preparation, wear suitable protective equipment (overalls, goggles and waterproof gloves). 

Do not eat, drink or smoke during product handling. Wash hands after use. In case of accidental ingestion, immediately wash mouth with water and seek medical attention. In case of accidental contact with skin, wash the area with water and soap. In case of accidental contact with eyes, rinse abundantly with clean tap water.

If irritation occurs on the skin after exposure, you should seek medical attention and show the package leaflet to your doctor. Swelling of the face, lips and eyes or difficulty breathing are severe symptoms and require urgent medical attention.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

No teratogenic, embryotoxic or maternotoxic effects have been observed in animal studies.

Do not use in poultry laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Beta-lactam and bacteriostatic enhancement effects. Incompatible with bivalent cations (calcium, magnesium, manganese).

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Overdose can cause gastrointestinal disorders. In this case it is necessary to stop the medication and administer symptomatic treatment.

INCOMPATIBILITIES

Incompatible with bivalent cations (calcium, magnesium, manganese).

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements.

Medicines should not be disposed of via waste water or household waste.

The treated animals will be kept in shelters throughout the treatment and the manure from them will be collected and SHALL NOT be used for soil fertilisation.

PRESENTATION/PACKAGE

The product is packaged in while 50mL, 100mL, 250mL, 500mL, 1L HDPE vials and 5L, 10L, 20L HDPE cans.