WAPCOLI® Oral Export only

Colistin Sulphate Oral Solution

For Veterinary Use Only

COMPOSITION

Each 1 ml contains:

Colistin Sulphate ........................................ 200,000 IU

Excipients .................................................... q.s. to 1 ml

Note: The concentration (IU/ml) should be adjusted according to the approved formulation and registration dossier.

PHARMACEUTICAL FORM

Clear to pale yellow oral solution for administration through drinking water.

TARGET SPECIES

Chickens and turkeys.

Target species should be confirmed according to the approved registration dossier.

INDICATIONS

WAPCOLI® Oral is indicated for the treatment of enteric infections caused by Gram-negative bacteria susceptible to colistin.

It is recommended for the treatment of:

• Colibacillosis

• Bacterial Enteritis

• Early gastrointestinal bacterial infections

• Enteric infections caused by susceptible Escherichia coli

• Secondary intestinal bacterial infections

Susceptible microorganisms may include:

• Escherichia coli

• Salmonella spp. (susceptible strains where approved)

• Klebsiella spp.

• Enterobacter spp.

• Other colistin-susceptible Gram-negative bacteria.

Treatment should whenever possible be based on bacterial culture and antimicrobial susceptibility testing.

PHARMACOLOGICAL PROPERTIES

Colistin is a polymyxin antibiotic with bactericidal activity against susceptible Gram-negative bacteria.

It acts by disrupting the bacterial outer cell membrane, resulting in leakage of intracellular contents and bacterial death.

Following oral administration, systemic absorption is minimal, allowing the product to act primarily within the intestinal tract.

DOSAGE AND ADMINISTRATION

For oral administration through drinking water.

Administer according to the veterinarian's instructions and the approved dosage in the country of registration.

The dosage should be calculated according to:

• Average body weight

• Daily water consumption

• Severity of infection

• Approved treatment duration

Prepare fresh medicated drinking water every 24 hours.

During treatment, medicated water should be the only source of drinking water.

PREPARATION OF MEDICATED WATER

Shake well before use.

Calculate the required volume according to flock body weight.

Mix thoroughly with clean drinking water until completely dispersed.

Prepare fresh medicated drinking water daily.

CONTRAINDICATIONS

Do not use:

• In animals hypersensitive to colistin or other polymyxins.

• In infections caused by colistin-resistant bacteria.

• In cases where local regulations prohibit its use.

SPECIAL WARNINGS

Use only under veterinary supervision.

Whenever possible, treatment should be based on antimicrobial susceptibility testing.

Official national and regional antimicrobial policies should be observed.

Colistin should be reserved for cases where treatment with other appropriate antimicrobial classes is not suitable or has failed, in accordance with local regulations.

Improper use may increase bacterial resistance.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Ensure continuous access to medicated drinking water.

Complete the prescribed treatment period.

Avoid underdosing.

Maintain good hygiene and biosecurity throughout treatment.

SPECIAL PRECAUTIONS FOR THE PERSON ADMINISTERING THE PRODUCT

Avoid contact with skin and eyes.

Wear suitable protective gloves while handling the product.

Wash hands thoroughly after use.

Avoid accidental ingestion.

Seek medical advice if irritation or allergic reactions occur.

ADVERSE REACTIONS

Occasionally mild gastrointestinal disturbances may occur.

Hypersensitivity reactions are uncommon.

If adverse reactions occur, discontinue treatment and consult a veterinarian.

DRUG INTERACTIONS

Do not mix with other veterinary medicinal products unless compatibility has been demonstrated.

Concurrent antimicrobial therapy should be based on veterinary judgement.

OVERDOSE

In case of accidental overdose, discontinue treatment and provide supportive care as required.

USE DURING LAY

Use only according to the approved registration in the country of use.

Do not use in laying birds producing eggs for human consumption unless specifically authorised.

WITHDRAWAL PERIOD

Withdrawal periods for meat and eggs should follow the approved registration dossier applicable in the country of registration.

STORAGE CONDITIONS

Store below 30°C.

Protect from direct sunlight.

Keep the container tightly closed.

Do not freeze.

Keep out of the reach of children.

SHELF LIFE

Shelf life of the unopened product:

36 months (subject to stability studies).

Shelf life after first opening should follow the approved registration dossier.

PACK SIZES

• 100 ml

• 250 ml

• 500 ml

• 1 L

• 5 L