WAPOXY® 50 WSP

Oxytetracycline Hydrochloride 50% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Oxytetracycline Hydrochloride ................. 500 mg

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

PHARMACEUTICAL FORM

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

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

It is recommended for the treatment of:

• Chronic Respiratory Disease (CRD)

• Colibacillosis

• Fowl Cholera

• Infectious Coryza

• Bacterial Enteritis

• Secondary bacterial respiratory infections

Susceptible microorganisms may include:

• Escherichia coli

• Pasteurella multocida

• Avibacterium paragallinarum

• Mycoplasma gallisepticum

• Mycoplasma synoviae

• Other oxytetracycline-susceptible bacteria.

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

PHARMACOLOGICAL PROPERTIES

Oxytetracycline is a broad-spectrum tetracycline antibiotic.

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

It is primarily bacteriostatic and is active against a wide range of Gram-positive, Gram-negative and Mycoplasma organisms susceptible to oxytetracycline.

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.

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 quantity according to the flock body weight.

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

Mix thoroughly until completely dissolved.

Prepare fresh medicated drinking water daily.

CONTRAINDICATIONS

Do not use:

• In animals hypersensitive to tetracyclines.

• In infections caused by oxytetracycline-resistant bacteria.

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

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 followed.

Improper use may increase bacterial resistance.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Ensure continuous access to medicated drinking water.

Complete the prescribed treatment course.

Avoid underdosing.

Good flock management and biosecurity should accompany 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 to tetracyclines should avoid handling the product.

ADVERSE REACTIONS

Occasionally gastrointestinal disturbances may occur.

Hypersensitivity reactions are uncommon.

Discontinue treatment if severe adverse reactions occur and consult a veterinarian.

DRUG INTERACTIONS

Do not administer simultaneously with products containing calcium, magnesium, iron or aluminum, as they may reduce the effectiveness of oxytetracycline.

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

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