WAPDOXY® 50 WSP

Doxycycline 50% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Doxycycline Hyclate
Equivalent to Doxycycline ................................ 500 mg

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

PHARMACEUTICAL FORM

Yellow to light-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

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

It is recommended for the treatment of susceptible infections involving:

• Chronic Respiratory Disease (CRD)

• Mycoplasmosis

• Infectious Synovitis

• Colibacillosis

• Fowl Cholera

• Ornithobacterium rhinotracheale (ORT)

• Secondary bacterial infections associated with viral respiratory diseases

Susceptible microorganisms may include:

• Mycoplasma gallisepticum

• Mycoplasma synoviae

• Escherichia coli

• Pasteurella multocida

• Ornithobacterium rhinotracheale

• Other doxycycline-susceptible bacteria

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

PHARMACOLOGICAL PROPERTIES

Doxycycline is a broad-spectrum tetracycline antibiotic.

It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, preventing bacterial growth.

Doxycycline is considered primarily bacteriostatic.

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.

Water consumption should be monitored daily to ensure correct dosing.

PREPARATION OF MEDICATED WATER

Calculate the required amount of WAPDOXY® 50 WSP according to the total body weight of the flock.

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

Ensure complete dissolution before administration.

Prepare fresh medicated water every day.

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

CONTRAINDICATIONS

Do not use:

• In animals with known hypersensitivity to doxycycline, tetracyclines or any excipient.

• In animals with severe hepatic impairment unless advised by a veterinarian.

• In cases where resistance to tetracyclines has been demonstrated.

SPECIAL WARNINGS

The use of the product should be based on bacterial susceptibility testing whenever possible.

Official national and regional antimicrobial policies should be taken into account.

Inappropriate use may increase the prevalence of doxycycline-resistant bacteria.

Animals with reduced water intake may require alternative treatment.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Use only under veterinary supervision.

Complete the full course of treatment even if clinical improvement occurs before the end of therapy.

Avoid underdosing.

Good flock management and biosecurity measures should accompany antimicrobial 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 when handling the product.

Wash hands thoroughly after use.

People with known hypersensitivity to tetracyclines should avoid handling this product.

In case of accidental eye contact, rinse immediately with plenty of water.

Seek medical advice if allergic reactions occur.

ADVERSE REACTIONS

Occasionally gastrointestinal disturbances may occur.

Photosensitivity and hypersensitivity reactions have rarely been reported.

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

DRUG INTERACTIONS

Do not administer simultaneously with products containing:

• Calcium

• Magnesium

• Iron

• Aluminum

These minerals may reduce the absorption of doxycycline.

Avoid concurrent administration with bactericidal antibiotics when not clinically indicated.

OVERDOSE

Doxycycline has a relatively wide margin of safety.

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

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 in the country where the product is marketed.

STORAGE CONDITIONS

Store below 25°C.

Keep in a dry place.

Protect from direct sunlight and moisture.

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