WAPTYLO® 50 WSP

Tylosin 50% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Tylosin Tartrate
Equivalent to Tylosin ................................ 500 mg

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

PHARMACEUTICAL FORM

Light yellow to 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

WAPTYLO® 50 WSP is indicated for the treatment of bacterial infections caused by microorganisms susceptible to tylosin.

It is recommended for the treatment of:

• Chronic Respiratory Disease (CRD)

• Mycoplasmosis

• Infectious Sinusitis

• Infectious Synovitis

• Airsacculitis

• Secondary bacterial respiratory infections

Susceptible microorganisms may include:

• Mycoplasma gallisepticum

• Mycoplasma synoviae

• Clostridium perfringens

• Streptococcus spp.

• Staphylococcus spp.

• Other tylosin-susceptible microorganisms.

Treatment should be based on bacterial susceptibility testing whenever possible.

PHARMACOLOGICAL PROPERTIES

Tylosin is a macrolide antibiotic.

It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, resulting primarily in a bacteriostatic effect.

Tylosin exhibits excellent activity against Mycoplasma species and many Gram-positive 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 determined according to:

• Average body weight

• Daily water consumption

• Severity of infection

• Recommended treatment duration

Prepare fresh medicated drinking water every 24 hours.

Medicated drinking water should be the only source of drinking water during treatment.

PREPARATION OF MEDICATED WATER

Calculate the required amount of product according to flock body weight.

Pre-dissolve WAPTYLO® 50 WSP in a small quantity of clean water before adding it to the drinking water system.

Ensure complete dissolution before administration.

Prepare fresh medicated water daily.

CONTRAINDICATIONS

Do not use:

• In animals with known hypersensitivity to tylosin or other macrolide antibiotics.

• In infections caused by microorganisms resistant to macrolides.

• Concurrently with other macrolides unless specifically recommended by a veterinarian.

SPECIAL WARNINGS

Use the product only when bacterial infection is suspected or confirmed.

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

Official national and regional antimicrobial policies should be observed.

Improper use may increase bacterial resistance to macrolides.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Use only under veterinary supervision.

Ensure adequate water intake throughout the treatment period.

Complete the full course of treatment.

Avoid underdosing.

Good biosecurity and management practices should accompany antimicrobial therapy.

SPECIAL PRECAUTIONS FOR THE PERSON ADMINISTERING THE PRODUCT

Avoid inhalation of dust.

Avoid contact with skin and eyes.

Wear protective gloves and a suitable dust mask during handling.

Wash hands thoroughly after use.

People with known hypersensitivity to macrolides should avoid contact with the product.

If accidental exposure occurs and allergic reactions develop, seek medical advice immediately.

ADVERSE REACTIONS

Occasionally mild gastrointestinal disturbances may occur.

Hypersensitivity reactions are rare.

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

DRUG INTERACTIONS

Do not administer simultaneously with other macrolide antibiotics unless advised by a veterinarian.

Concurrent administration with bactericidal antibiotics should be carefully evaluated.

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

OVERDOSE

Tylosin has a relatively wide safety margin.

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

USE DURING LAY

Use only in accordance with 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 the 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