WAPFOS® 20 WSP

Fosfomycin Calcium 20% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Fosfomycin Calcium ..................................... 200 mg

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

PHARMACEUTICAL FORM

White to off-white 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

WAPFOS® 20 WSP is indicated for the treatment of bacterial infections caused by microorganisms susceptible to fosfomycin.

It is recommended for the treatment of:

• Colibacillosis

• Salmonellosis (susceptible strains)

• Chronic Respiratory Disease (CRD) associated with susceptible bacteria

• Bacterial Enteritis

• Secondary bacterial respiratory infections

• Mixed bacterial infections caused by susceptible organisms

Susceptible microorganisms may include:

• Escherichia coli

• Salmonella spp.

• Pasteurella multocida

• Avibacterium paragallinarum

• Other fosfomycin-susceptible bacteria.

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

PHARMACOLOGICAL PROPERTIES

Fosfomycin is a broad-spectrum bactericidal antibiotic.

It inhibits bacterial cell wall synthesis by blocking the enzyme MurA, preventing the formation of peptidoglycan during the early stages of cell wall development.

Its unique mechanism of action makes it active against many susceptible Gram-positive and Gram-negative 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

• 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 quantity according to flock body weight.

Pre-dissolve the product in a small quantity of clean drinking 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 fosfomycin or any component of the formulation.

• In infections caused by fosfomycin-resistant microorganisms.

• Except in accordance with local regulatory approval.

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.

Improper use may increase bacterial resistance.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Ensure birds have continuous access to medicated drinking water.

Complete the prescribed treatment course.

Avoid underdosing.

Maintain appropriate hygiene and biosecurity throughout treatment.

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 while handling the product.

Wash hands thoroughly after use.

People with known hypersensitivity should avoid handling the 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 mix with other veterinary medicinal products unless compatibility has been demonstrated.

Concurrent antimicrobial therapy should be based on veterinary judgment.

OVERDOSE

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

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 and direct sunlight.

Keep the container tightly closed after opening.

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