देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
LEVOCETIRIZINE DIHYDROCHLORIDE
KRKA Pharma Dublin Limited
5 Milligram
Film Coated Tablet
2011-07-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine Krka 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipient: 88.63 mg lactose/tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet The tablets are white, round, biconvex film-coated tablets with bevelled edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF 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. Adults and adolescents 12 years of age and above: The recommended daily dose is 5 mg (1 film-coated tablet). Elderly patients: Adjustment of the daily dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below). Children aged 6 to 12 years: The recommended daily dose is 5 mg (1 film-coated tablet). For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocitirizine. Patients with renal impairment: The dosing intervals must be adjusted individually 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: _CL_ _CR_ _=_ [140_-age(years)_] × _body weight (kg)_ _(_× 0.85 _for women)_ 72 × _serum creatinine (mg/dl)_ IRISH MEDICINES BOARD _____ पूरा दस्तावेज़ पढ़ें