WAPTRIM-S® WSP

Trimethoprim + Sulfadiazine Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Trimethoprim ........................................ 100 mg

Sulfadiazine Sodium ............................... 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 and turkeys.

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

INDICATIONS

WAPTRIM-S® WSP is indicated for the treatment of bacterial infections caused by microorganisms susceptible to the combination of trimethoprim and sulfadiazine.

It is recommended for the treatment of:

• Colibacillosis

• Fowl Cholera

• Infectious Coryza

• Salmonellosis (susceptible strains)

• Bacterial Enteritis

• Secondary bacterial respiratory infections

• Mixed bacterial infections

Susceptible microorganisms may include:

• Escherichia coli

• Pasteurella multocida

• Avibacterium paragallinarum

• Salmonella spp. (susceptible strains)

• Staphylococcus spp.

• Streptococcus spp.

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

PHARMACOLOGICAL PROPERTIES

Trimethoprim and sulfadiazine act synergistically by inhibiting two sequential steps in bacterial folic acid synthesis, producing a broad-spectrum antibacterial effect.

The combination is active against numerous Gram-positive and Gram-negative bacteria susceptible to potentiated sulfonamides.

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 water should be the only source of drinking water.

PREPARATION OF MEDICATED WATER

Calculate the required quantity according to the total flock body weight.

Pre-dissolve the product in a small quantity of clean 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 sulfonamides or trimethoprim.

• In animals with severe liver or kidney impairment unless specifically advised by a veterinarian.

• In infections caused by resistant microorganisms.

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 period.

Avoid underdosing.

Maintain good 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 to sulfonamides should avoid contact with 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 administer concurrently with other folic acid antagonists unless recommended by a veterinarian.

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 required.

Ensure adequate water intake during recovery.

USE DURING LAY

Use only according to the approved registration in the country of use.

Do not use in 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