WAPFIRO® Chewable Tablets

Firocoxib Chewable Tablets

For Veterinary Use Only

COMPOSITION

WAPFIRO® 57

Each chewable tablet contains:

Firocoxib ................................................ 57 mg

Excipients ............................................... q.s.

WAPFIRO® 227

Each chewable tablet contains:

Firocoxib .............................................. 227 mg

Excipients ............................................... q.s.

PHARMACEUTICAL FORM

Palatable, scored chewable tablets for oral administration.

TARGET SPECIES

Dogs

INDICATIONS

WAPFIRO® is indicated for the control of pain and inflammation associated with:

• Osteoarthritis

• Degenerative joint disease

• Hip and elbow dysplasia

• Musculoskeletal disorders

• Lameness

• Orthopedic surgery

• Soft-tissue surgery

• Post-operative pain and inflammation

PHARMACOLOGICAL PROPERTIES

Firocoxib is a non-steroidal anti-inflammatory drug belonging to the coxib class.

It selectively inhibits cyclooxygenase-2 (COX-2), reducing the formation of prostaglandins involved in pain, inflammation and fever.

WAPFIRO® provides:

• Analgesic activity

• Anti-inflammatory activity

• Antipyretic activity

• Once-daily administration

DOSAGE AND ADMINISTRATION

Administer orally at:

5 mg firocoxib/kg body weight once daily.

The tablets may be administered with or without food.

For osteoarthritis, treatment duration should be determined according to the clinical response and veterinary assessment.

For post-operative pain and inflammation, treatment may begin approximately 2 hours before surgery and continue once daily for up to 3 days, or according to the approved local product information.

DOSAGE GUIDE

The final dosing table must be aligned with the tablet score design and approved registration dossier.

CONTRAINDICATIONS

Do not use in:

• Dogs with known hypersensitivity to firocoxib

• Animals with gastrointestinal ulceration or bleeding

• Animals suffering from severe renal, hepatic or cardiac disease

• Animals with blood-clotting disorders

Do not administer concurrently with other NSAIDs or corticosteroids.

SPECIAL WARNINGS

For oral use in dogs only.

Use with caution in dehydrated, hypovolemic or hypotensive animals because of the potential risk of renal toxicity.

Clinical examination and appropriate laboratory evaluation should be considered before initiating long-term NSAID therapy.

Doses exceeding 5 mg/kg in puppies younger than seven months have been associated with serious adverse reactions.

SPECIAL PRECAUTIONS FOR USE

Monitor dogs receiving prolonged treatment for changes in:

• Appetite

• Body weight

• Gastrointestinal function

• Renal parameters

• Hepatic parameters

A suitable treatment-free interval should be considered when switching from another NSAID or corticosteroid.

ADVERSE REACTIONS

Possible adverse reactions include:

• Vomiting

• Diarrhea

• Soft feces

• Reduced appetite

• Lethargy

Rare but potentially serious reactions include:

• Gastrointestinal ulceration or bleeding

• Renal dysfunction

• Hepatic dysfunction

• Neurological abnormalities

Discontinue treatment and consult a veterinarian if adverse effects occur.

USE DURING PREGNANCY AND LACTATION

Do not use during pregnancy, lactation or breeding unless specifically supported by the approved registration dossier and a veterinary benefit-risk assessment.

DRUG INTERACTIONS

Do not administer together with:

• Other NSAIDs

• Corticosteroids

Use caution with medicines that may affect renal perfusion or exhibit high protein binding.

OVERDOSE

Overdose may result in:

• Vomiting

• Diarrhea

• Reduced appetite

• Weight loss

• Gastrointestinal ulceration

• Renal or hepatic abnormalities

There is no specific antidote. Provide symptomatic and supportive treatment.

STORAGE

Store below 25°C.

Protect from moisture and direct sunlight.

Keep in the original package.

Use divided tablets within the period specified in the approved product dossier.

SHELF LIFE

36 months, subject to stability-study confirmation.

PRESENTATION

Available strengths:

• WAPFIRO® 57 mg

• WAPFIRO® 227 mg

Proposed pack sizes:

• 10 chewable tablets

• 30 chewable tablets

• 60 chewable tablets