WAPMOX® 50 WSP

Amoxicillin 50% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Amoxicillin Trihydrate
Equivalent to Amoxicillin ................................ 500 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, turkeys and ducks.

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

INDICATIONS

WAPMOX® 50 WSP is indicated for the treatment of bacterial infections caused by microorganisms susceptible to amoxicillin in poultry.

It may be used in the treatment of susceptible bacterial infections involving:

• The respiratory tract

• The gastrointestinal tract

• Septicemic infections

• Secondary bacterial complications

Susceptible microorganisms may include:

• Escherichia coli

• Pasteurella multocida

• Avibacterium paragallinarum

• Other amoxicillin-susceptible bacteria

The product is not effective against beta-lactamase-producing bacteria.

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

PHARMACOLOGICAL PROPERTIES

Amoxicillin is a broad-spectrum bactericidal antibiotic belonging to the aminopenicillin group.

It acts by inhibiting the synthesis of the bacterial cell wall, resulting in bacterial cell lysis and death.

DOSAGE AND ADMINISTRATION

For oral administration through drinking water.

Administer according to the veterinarian’s directions and the dosage approved in the country of registration.

A typical dosage calculation should be based on:

• The animals’ average body weight

• The daily water consumption

• The severity of the infection

• The concentration of amoxicillin required

• The approved treatment duration

Prepare fresh medicated drinking water every 24 hours.

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

To ensure the correct dosage, body weight should be determined as accurately as possible.

Water consumption should be monitored regularly, as it may vary according to age, health condition, environmental temperature and management conditions.

PREPARATION OF MEDICATED WATER

Calculate the required quantity of WAPMOX® 50 WSP according to the total body weight of the birds and their estimated daily water consumption.

Dissolve the calculated quantity in a small amount of clean drinking water, mix thoroughly and then add it to the total volume of water required.

Ensure complete and uniform dissolution before administration.

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

CONTRAINDICATIONS

Do not use:

• In animals with known hypersensitivity to penicillins, cephalosporins or other beta-lactam antibiotics.

• In infections caused by beta-lactamase-producing bacteria.

• In rabbits, guinea pigs, hamsters, gerbils or other small herbivores.

• In animals with severe renal dysfunction unless advised by a veterinarian.

• When resistance to amoxicillin has been confirmed.

SPECIAL WARNINGS

The use of this product should be based on the identification and susceptibility testing of the target pathogen whenever possible.

Official, national and regional antimicrobial policies should be considered when the product is used.

Inappropriate or unnecessary use may increase the prevalence of bacteria resistant to amoxicillin and other beta-lactam antibiotics.

Animals with severely reduced water intake may not receive an adequate dose and may require alternative treatment.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Do not use for routine disease prevention or growth promotion.

Avoid underdosing, as this may increase the risk of antimicrobial resistance.

Complete the prescribed treatment course, even if clinical signs improve before the end of treatment.

The product should be used only under veterinary supervision.

SPECIAL PRECAUTIONS FOR THE PERSON ADMINISTERING THE PRODUCT

Penicillins and cephalosporins may cause hypersensitivity reactions following inhalation, ingestion or skin contact.

People with known hypersensitivity to penicillins or cephalosporins should avoid handling the product.

Avoid inhalation of dust.

Avoid contact with the skin and eyes.

Wear suitable protective gloves, protective clothing and a dust mask when handling the product.

Wash hands thoroughly after use.

In case of accidental contact with the eyes, rinse immediately with plenty of clean water.

If signs of an allergic reaction occur, such as skin rash, facial swelling or difficulty breathing, seek medical attention immediately and show the product label or leaflet to the physician.

ADVERSE REACTIONS

Hypersensitivity reactions may occur in rare cases.

Gastrointestinal disturbances may occasionally occur.

If a serious adverse reaction or allergic response occurs, discontinue treatment immediately and seek veterinary advice.

DRUG INTERACTIONS

Do not administer simultaneously with bacteriostatic antibiotics such as tetracyclines, macrolides, sulfonamides or chloramphenicol derivatives unless specifically advised by a veterinarian.

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

Synergistic activity may occur with aminoglycosides, but combined use should only be undertaken under veterinary supervision.

OVERDOSE

Amoxicillin generally has a wide safety margin.

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

USE DURING LAY

Do not use in birds producing eggs for human consumption unless specifically authorised in the country of registration.

The approved label instructions for laying birds must always be followed.

WITHDRAWAL PERIOD

Meat and offal: To be established according to the approved registration dossier.

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

The locally approved withdrawal periods must be stated on the final product label and leaflet.

STORAGE CONDITIONS

Store below 25°C.

Store in a cool, dry place.

Protect from direct sunlight and moisture.

Keep the container tightly closed after opening.

Keep out of the sight and reach of children.

SHELF LIFE

Shelf life of the unopened veterinary medicinal product: To be confirmed by stability studies.

Shelf life after first opening: To be established according to stability data.

Shelf life of medicated drinking water: Use within 24 hours unless otherwise specified in the approved dossier.

PACK SIZES

100 g
500 g
1 kg