WAPVALO® 62.5 WSG

Tylvalosin 62.5% Water-Soluble Granules

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Tylvalosin (as Tylvalosin Tartrate) ............... 625 mg

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

PHARMACEUTICAL FORM

Yellow to light-brown water-soluble granules for oral administration through drinking water.

TARGET SPECIES

Chickens and turkeys.

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

INDICATIONS

WAPVALO® 62.5 WSG is indicated for the treatment and metaphylactic control (where approved) of bacterial respiratory infections caused by microorganisms susceptible to tylvalosin.

It is recommended for the treatment of:

• Chronic Respiratory Disease (CRD)

• Mycoplasmosis

• Infectious Airsacculitis

• Infectious Sinusitis

• Infectious Synovitis

• Ornithobacterium rhinotracheale (ORT) infections caused by susceptible strains

• Secondary bacterial respiratory infections

Susceptible microorganisms may include:

• Mycoplasma gallisepticum

• Mycoplasma synoviae

• Ornithobacterium rhinotracheale

• Other tylvalosin-susceptible microorganisms

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

PHARMACOLOGICAL PROPERTIES

Tylvalosin is a third-generation macrolide antibiotic.

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

Tylvalosin demonstrates excellent activity against Mycoplasma spp. and several important respiratory pathogens affecting poultry.

DOSAGE AND ADMINISTRATION

For oral administration via drinking water.

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

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 drinking water should be the only source of drinking water.

PREPARATION OF MEDICATED WATER

Calculate the required amount of WAPVALO® 62.5 WSG according to the total flock body weight.

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

Mix thoroughly until completely dissolved.

Prepare fresh medicated drinking water daily.

CONTRAINDICATIONS

Do not use:

• In animals hypersensitive to tylvalosin or other macrolide antibiotics.

• In infections caused by resistant microorganisms.

• Concurrently with other macrolides unless recommended by a veterinarian.

SPECIAL WARNINGS

The product should be used only under veterinary supervision.

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

Ensure birds have unrestricted access to medicated drinking water.

Complete the prescribed treatment course.

Avoid underdosing.

Good flock management and biosecurity should accompany antimicrobial treatment.

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 while handling the product.

Wash hands thoroughly after use.

Individuals with known hypersensitivity to macrolides should avoid handling this product.

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 administer simultaneously with other macrolide antibiotics unless specifically recommended.

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

OVERDOSE

Tylvalosin has a relatively wide safety margin.

In case of accidental 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.

Store in a cool, dry place.

Protect from moisture.

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