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
Documents
Package Inserts
Telfast suspension_PI.pdf
Approved: August 24, 2022