Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
loratadine
Arpimed LLC
R06AX13
loratadine
10mg
tablets
(10/1x10/) in blister
OTC
Registered
2018-08-07
SUMMARY PRODUCT CHARACTERISTIC (SPC) LORATADINE 10 MG TABLETS 1.1 BRAND NAME – LORATADINE 1.2 INTERNATIONAL NON-PROPERTY NAME - LORATADINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: _ACTIVE INGREDIENT:_ loratadine - 10 mg; _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM Tablet. White scored cylindrical tablets, the end surface of which are flat. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loratadine are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years with a body weight more than 30 kg. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS Posology _Adults and children over 12 years of age:_ 10mg once daily (one tablet once daily). Paediatric population C_hildren 2 to 12 years of age are dosed by weight:_ Bodyweight more than 30kg: 10mg once daily (one tablet once daily). Bodyweight 30kg or less: The 10mg strength tablet is not appropriate in children with a bodyweight less than 30kg. There are other formulations more suitable for children 2 to 12 years old with body weight 30 kg or less. The safety and efficacy of Loratadine in children under 2 years of age has not been established. No data are available. _Patients with hepatic impairment_ Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg. _Patients with renal impairment_ No dosage adjustments are required in patients with renal insufficiency. _Elderly_ No dosage adjustments are required in the elderly. Method of administration Oral use. The tablet may be taken without regard to mealtime. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Loratadine should be administered with caution in patients with severe liver impairment ( Đọc toàn bộ tài liệu