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HSA Approval

Telfast Oral Suspension 6 mg/ml

SIN14199P

Telfast Oral Suspension 6 mg/ml

Telfast Oral Suspension 6 mg/ml

July 20, 2012

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Regulatory Information

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SUSPENSION

**DOSAGE AND ADMINISTRATION** Seasonal Allergic Rhinitis _Children 2 to 11 Years:_ The recommended dose of TELFAST oral suspension is 30 mg twice daily. A dose of 30 mg (5 mL) once daily is recommended as the starting dose in pediatric patients with decreased renal function _\[see Clinical Pharmacology_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Shake bottle well, before each use. Chronic Idiopathic Urticaria _Children 6 Months to 11 years:_ The recommended dose of TELFAST oral suspension is 30 mg (5 mL) twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of TELFAST oral suspension are 30 mg (5 mL) once daily for patients 2 to 11 years of age and 15 mg (2.5 mL) once daily for patients 6 months to less than 2 years of age _\[see Clinical Pharmacology_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Shake bottle well, before each use.

ORAL

Medical Information

**INDICATIONS AND USAGE** - **Seasonal Allergic Rhinitis** TELFAST is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. - **Chronic Idiopathic Urticaria** TELFAST is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

**CONTRAINDICATIONS** TELFAST oral suspension is contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of TELFAST. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

R06AX26

fexofenadine

Manufacturer Information

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

SANOFI MEDLEY FARMACÊUTICA LTDA.

Active Ingredients

Fexofenadine 28 mg/5 ml eqv Fexofenadine hydrochloride

30.00 mg/5 ml

Fexofenadine

Documents

Package Inserts

Telfast suspension_PI.pdf

Approved: August 24, 2022

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