WAPFLOR® 20 Oral

Florfenicol 20% Oral Solution

For Veterinary Use Only

COMPOSITION

Each 1 ml contains:

Florfenicol ............................................... 200 mg

Excipients .................................................. q.s. to 1 ml

PHARMACEUTICAL FORM

Clear yellow to amber oral solution for administration in drinking water.

TARGET SPECIES

Chickens and turkeys.

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

INDICATIONS

WAPFLOR® 20 Oral is indicated for the treatment of bacterial infections caused by microorganisms susceptible to florfenicol.

It is recommended for the treatment of:

• Chronic Respiratory Disease (CRD)

• Colibacillosis

• Fowl Cholera

• Infectious Airsacculitis

• Secondary bacterial respiratory infections

• Septicemic bacterial infections caused by susceptible organisms

Susceptible microorganisms may include:

• Escherichia coli

• Pasteurella multocida

• Avibacterium paragallinarum

• Ornithobacterium rhinotracheale

• Other florfenicol-susceptible bacteria.

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

PHARMACOLOGICAL PROPERTIES

Florfenicol is a broad-spectrum synthetic antibiotic belonging to the amphenicol group.

It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation and bacterial multiplication.

Florfenicol is active against a wide range of Gram-positive and Gram-negative bacteria, including many respiratory pathogens of poultry.

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 drinking water should be the only source of drinking water.

DIRECTIONS FOR USE

Shake well before use.

Measure the required quantity accurately.

Mix thoroughly with the calculated volume of drinking water until a homogeneous solution is obtained.

Prepare fresh medicated water daily.

Do not use medicated water remaining after 24 hours.

CONTRAINDICATIONS

Do not use:

• In animals hypersensitive to florfenicol or any component of the formulation.

• In infections caused by florfenicol-resistant bacteria.

• In laying birds producing eggs for human consumption unless specifically authorised.

SPECIAL WARNINGS

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

Official national and regional antimicrobial policies should be observed.

Improper use may increase bacterial resistance.

Animals with reduced water intake may require alternative treatment.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Ensure birds have continuous access to medicated drinking water.

Complete the prescribed course of treatment.

Avoid underdosing.

Maintain good flock management and biosecurity throughout treatment.

SPECIAL PRECAUTIONS FOR THE PERSON ADMINISTERING THE PRODUCT

Avoid contact with skin and eyes.

Wear suitable protective gloves while handling the product.

Wash hands thoroughly after use.

Do not eat, drink or smoke while handling the product.

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

If irritation persists, seek medical advice.

ADVERSE REACTIONS

Occasionally reduced feed intake or transient gastrointestinal disturbances may occur.

Hypersensitivity reactions are rare.

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

DRUG INTERACTIONS

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

Concurrent administration with other antimicrobial agents should be based on veterinary judgement.

OVERDOSE

Florfenicol has a relatively wide safety margin.

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

USE DURING LAY

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

WITHDRAWAL PERIOD

Withdrawal periods for meat and eggs should follow the approved registration dossier applicable in the country of registration.

STORAGE CONDITIONS

Store below 30°C.

Protect from direct sunlight.

Keep the container tightly closed.

Do not freeze.

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 dilution should follow the approved registration dossier.

PACK SIZES

• 100 ml

• 250 ml

• 500 ml

• 1 L

• 5 L