Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
Fexofenadine 28 mg/5 ml eqv Fexofenadine hydrochloride
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
R06AX26
30.00 mg/5 ml
SUSPENSION
Fexofenadine 28 mg/5 ml eqv Fexofenadine hydrochloride 30.00 mg/5 ml
ORAL
Prescription Only
SANOFI MEDLEY FARMACÊUTICA LTDA.
ACTIVE
2012-07-20
INDICATIONS AND USAGE Ŧ 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. Ŧ 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. 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]_. 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]_ Shake bottle well, before each use. DOSAGE FORMS AND STRENGTHS TELFAST oral suspension is available as 30 mg/ 5 mL (6 mg/mL). 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. ADVERSE REACTIONS CLINICAL STUDIES EXPERIENCE Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obse Прочитать полный документ
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