WAPROFLOX® 10 Oral Export only

Enrofloxacin 10% Oral Solution

For Veterinary Use Only

COMPOSITION

Each 1 ml contains:

Enrofloxacin .............................................. 100 mg

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

PHARMACEUTICAL FORM

Clear yellow to pale amber oral solution for administration through drinking water.

TARGET SPECIES

Chickens and turkeys.

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

INDICATIONS

WAPROFLOX® 10 Oral is indicated for the treatment of bacterial infections caused by microorganisms susceptible to enrofloxacin.

It is recommended for the treatment of:

• Colibacillosis

• Fowl Cholera

• Chronic Respiratory Disease (CRD) associated with susceptible bacteria

• Infectious Coryza

• Salmonellosis (susceptible strains)

• Secondary bacterial respiratory infections

Susceptible microorganisms may include:

• Escherichia coli

• Pasteurella multocida

• Avibacterium paragallinarum

• Mycoplasma gallisepticum

• Mycoplasma synoviae

• Other enrofloxacin-susceptible bacteria.

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

PHARMACOLOGICAL PROPERTIES

Enrofloxacin is a fluoroquinolone antibiotic with broad-spectrum bactericidal activity.

It inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and resulting in rapid bacterial death.

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 determined 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 total flock body weight.

Mix thoroughly with clean drinking water until completely dispersed.

Prepare fresh medicated drinking water every day.

CONTRAINDICATIONS

Do not use:

• In animals hypersensitive to enrofloxacin or other fluoroquinolones.

• In infections caused by fluoroquinolone-resistant bacteria.

• Except in accordance with local regulatory approval.

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.

Use of fluoroquinolones should be reserved for cases where other appropriate antimicrobial classes are expected to be ineffective or have failed.

Improper use may increase bacterial resistance to fluoroquinolones.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Ensure continuous access to medicated drinking water.

Complete the prescribed treatment course.

Avoid underdosing.

Good biosecurity and flock management should accompany antimicrobial 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.

Avoid accidental ingestion.

Seek medical advice if hypersensitivity reactions occur.

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 products containing high concentrations of calcium, magnesium, iron or aluminum unless compatibility has been established.

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.

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 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 should follow the approved registration dossier.

PACK SIZES

• 100 ml

• 250 ml

• 500 ml

• 1 L

• 5 L

Not all pack sizes may be marketed.