WAPMULIN® 45 WSP

Tiamulin 45% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Tiamulin Hydrogen Fumarate
Equivalent to Tiamulin ................................. 450 mg

Excipients ........................................................ q.s. to 1 g

PHARMACEUTICAL FORM

White to pale yellow water-soluble powder for oral administration through drinking water.

TARGET SPECIES

Chickens and turkeys.

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

INDICATIONS

WAPMULIN® 45 WSP is indicated for the treatment of bacterial infections caused by microorganisms susceptible to tiamulin.

It is recommended for the treatment of:

• Chronic Respiratory Disease (CRD)

• Mycoplasmosis

• Infectious Airsacculitis

• Infectious Synovitis

• Necrotic Enteritis associated with susceptible Clostridium perfringens

• Secondary bacterial respiratory infections

Susceptible microorganisms may include:

• Mycoplasma gallisepticum

• Mycoplasma synoviae

• Clostridium perfringens

• Other tiamulin-susceptible bacteria

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

PHARMACOLOGICAL PROPERTIES

Tiamulin is a semi-synthetic pleuromutilin antibiotic.

It inhibits bacterial protein synthesis by binding selectively to the 50S ribosomal subunit, thereby preventing bacterial multiplication.

Tiamulin has excellent activity against Mycoplasma species and several Gram-positive anaerobic bacteria.

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

Calculate the required amount of WAPMULIN® 45 WSP according to flock body weight.

Pre-dissolve the product in a small quantity of clean water before adding it to the drinking water system.

Mix thoroughly until completely dissolved.

Prepare fresh medicated drinking water daily.

CONTRAINDICATIONS

Do not use:

• In animals hypersensitive to tiamulin or any component of the formulation.

• Simultaneously or within 7 days before or after administration of ionophore anticoccidials such as monensin, salinomycin or narasin, as severe growth depression, toxicity or death may occur.

• In infections caused by tiamulin-resistant bacteria.

SPECIAL WARNINGS

The product should be used only under veterinary supervision.

Treatment should be based on bacterial susceptibility testing whenever possible.

Improper use may increase bacterial resistance.

Always follow official national antimicrobial policies.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Do not administer simultaneously with incompatible ionophore anticoccidials.

Ensure birds have continuous access to medicated drinking water.

Complete the entire treatment course.

Maintain good hygiene and biosecurity throughout the treatment period.

SPECIAL PRECAUTIONS FOR THE PERSON ADMINISTERING THE PRODUCT

Avoid inhalation of dust.

Avoid contact with skin and eyes.

Wear suitable protective gloves and a dust mask.

Wash hands thoroughly after handling.

People with known hypersensitivity should avoid contact with the product.

ADVERSE REACTIONS

Occasionally mild gastrointestinal disturbances may occur.

Hypersensitivity reactions are rare.

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

DRUG INTERACTIONS

Do not administer concurrently with ionophore anticoccidials including:

• Monensin

• Salinomycin

• Narasin

Severe toxicity may occur.

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

OVERDOSE

Tiamulin has a relatively wide safety margin.

In case of overdose, discontinue treatment and provide supportive therapy.

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 25°C.

Keep in a dry place.

Protect from moisture and direct sunlight.

Keep the container tightly closed.

Keep out of the reach of children.

SHELF LIFE

Shelf life of unopened product:

36 months (subject to stability studies).

Shelf life after first opening and after preparation of medicated drinking water should follow the approved registration dossier.

PACK SIZES

• 100 g

• 500 g

• 1 kg