देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LEVOCETIRIZINE HYDROCHLORIDE
GLAXO WELLCOME INDONESIA - Indonesia
LEVOCETIRIZINE HYDROCHLORIDE
5 MG
KAPLET SALUT SELAPUT
DUS, 5 BLISTER @ 10 KAPLET SALUT SELAPUT
UCB PHARMA SPA - Switzerland
2017-05-23
_Page 1 of 8_ XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. 2. PHARMACEUTICAL FORM White to off-white, oval, film-coated tablet with a Y logo on one side. 3. CLINICAL INFORMATION_ _ 3.1 INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopatic urticaria. 3.2 DOSAGE AND ADMINISTRATION The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake. DURATION OF USE The duration of use depends on the type, duration and cause of the complaints. For hay fever 3-6 weeks and in case of short-term pollen exposure as little as one week, is generally sufficient. Clinical experience with 5 mg levocetirizine as a film-coated tablet formulation is currently available for a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, up to one year's clinical experience is available for the racemate and up to 18 months in patients with pruritus associated with atopic dermatitis. ROUTE OF ADMINISTRATION For oral use. ADULTS AND CHILDREN 6 YEARS ABOVE: The daily recommended dose is 5 mg (1 film coated tablet). For children aged less than 6 years no adjusted dosage is yet possible. ELDERLY Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment _(see renal impairment). _ _ _ RENAL IMPAIRMENT The dosing intervals must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. The CLcr (mL/min) may be estimated from serum creatinine (mg/dL) determination using the following formula: [140 _ - age (years_ )] x _ weight (kg) _ CLcr _ = _ _ _ _ _ _ _ _ ( _ x 0.85 _ for women) _ 72 x _ serum creatinine (mg / dL) _ _ _ Dosing Adjustment for Patients with I पूरा दस्तावेज़ पढ़ें