국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
levocetirizine (levocetirizine dihydrochloride)
Aesica Pharmaceuticals S.r.l.
levocetirizine (levocetirizine dihydrochloride)
5mg
tablets film-coated
OTC
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xyzal, Levocetirizine dihydrochloride, 5 mg, film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. 3. PHARMACEUTICAL FORM _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ White to off-white, oval, film-coated tablet with a Y logo on one side. 4. CLINICAL INFORMATION 4.1 INDICATIONS For the symptomatic treatment of: • allergic rhinitis (including persistent allergic rhinitis), • urticaria. 4.2 DOSAGE AND ADMINISTRATION _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ 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 _ Intermittent allergic rhinitis (symptoms < 4 days/week or during less than 4 weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. Page 2 of 16 In case of persistent allergic rhinitis (symptoms > 4 days/week or for more than 4 weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens. There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. For chronic urticaria and chronic allergic rhinitis, up to one year's clinical experience is available for the racemate. ROUTE OF ADMINISTRATION For oral use. ADULTS AND ADOLESCENTS 12 YEARS AND ABOVE: _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ The daily recommended dose is 5 mg (1 film-coated tablet)._ _ CHILDREN _Children aged less than 2 years _ The administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended _(see Section Warnings and Precautions)_._ _ _Children aged 2 to 6 years _ _Levocetirizine dihydrochlo 전체 문서 읽기