WAPNEO® 50 WSP

Neomycin Sulphate 50% Water-Soluble Powder

For Veterinary Use Only

COMPOSITION

Each 1 g contains:

Neomycin Sulphate
Equivalent to Neomycin ................................ 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

WAPNEO® 50 WSP is indicated for the treatment of bacterial enteric infections caused by microorganisms susceptible to neomycin.

It is recommended for the treatment of:

• Colibacillosis

• Bacterial Enteritis

• Enteric infections caused by susceptible Gram-negative bacteria

• Secondary bacterial intestinal infections

• Early bacterial gastrointestinal infections

Susceptible microorganisms may include:

• Escherichia coli

• Salmonella spp. (susceptible strains)

• Klebsiella spp.

• Enterobacter spp.

• Other neomycin-susceptible Gram-negative bacteria

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

PHARMACOLOGICAL PROPERTIES

Neomycin is an aminoglycoside antibiotic with broad-spectrum activity against many Gram-negative bacteria.

It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, resulting in irreversible inhibition of bacterial growth and cell death.

Following oral administration, neomycin is poorly absorbed from the gastrointestinal tract, making it particularly effective for the treatment of intestinal infections.

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.

PREPARATION OF MEDICATED WATER

Calculate the required quantity of WAPNEO® 50 WSP according to flock body weight.

Pre-dissolve the product in a small amount 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 neomycin or other aminoglycosides.

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

• In infections caused by neomycin-resistant microorganisms.

SPECIAL WARNINGS

Use only under veterinary supervision.

Treatment should whenever possible be based on antimicrobial susceptibility testing.

Official national and regional antimicrobial policies should be considered.

Improper use may increase bacterial resistance.

The product is intended primarily for intestinal infections due to its limited gastrointestinal absorption.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Ensure adequate water intake throughout treatment.

Complete the prescribed course of therapy.

Avoid underdosing.

Good hygiene and flock management 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 while handling the product.

Wash hands thoroughly after use.

People with known hypersensitivity to aminoglycosides should avoid contact with the product.

If accidental exposure causes allergic reactions, seek medical advice immediately.

ADVERSE REACTIONS

Occasionally mild gastrointestinal disturbances may occur.

Hypersensitivity reactions are rare.

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

DRUG INTERACTIONS

Avoid concurrent administration with other nephrotoxic or ototoxic drugs unless recommended by a veterinarian.

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

OVERDOSE

Neomycin has a relatively wide safety margin following oral administration because of its limited gastrointestinal absorption.

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

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.

Keep 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