Страна: Сінгапур
мова: англійська
Джерело: HSA (Health Sciences Authority)
LORATADINE (MICRONIZED)
BAYER (SOUTH EAST ASIA) PTE LTD
R06AX13
5 mg/5 ml
SYRUP
LORATADINE (MICRONIZED) 5 mg/5 ml
ORAL
General Sale List
PT Merck Sharp Dohme Pharma Tbk
ACTIVE
1995-02-02
Brand of loratadine, a potent, long-acting & non-sedating antihistamine PACKAGE INSERT FOR MALAYSIA MARKET 1. NAME OF THE MEDICINAL PRODUCT Clarityne® Tablet 10mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each CLARITYNE® Tablet contains 10 mg micronized loratadine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CLARITYNE® Tablet: White to off-white oval tablet with score on one side, and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CLARITYNE® Products are indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. CLARITYNE® Products are also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and Children 12 years of age and over: _ CLARITYNE® Tablet: One tablet (10 mg) once daily; _Children 6 to 12 years of age: _ CLARITYNE® TABLET: Body Weight >30 kg -- One tablet (10 mg) once daily Safety and efficacy of CLARITYNE® has not been established in children younger than 2 years of age. Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5 mg once daily, or 10 mg every other day is recommended. 4.3 CONTRAINDICATIONS CLARITYNE® Products are contraindicated in patients who are hypersensitivity to the active substance or to any of the excipients in these formulations. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE CLARITYNE® Products should be administered with caution in patients with severe liver impairment (see section 4.2). CLARITYNE® Tablet: This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine. The administr Прочитайте повний документ