Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
I tablet-dark yellow- estradiol (estradiol valerate), II tablet-pink- estradiol (estradiol valerate), dienogest, III tablet- light yellow- estradiol (estradiol valerate), dienogest, IV tablet-red-estradiol (estradiol valerate), V tablet-white-inactive
Bayer Weimar GmbH & Co. KG
I tablet-dark yellow- estradiol (estradiol valerate), II tablet-pink- estradiol (estradiol valerate), dienogest, III tablet- lig
3mg+(2mg+2mg)+(2mg+3mg)+1mg
tablets film-coated
Prescription
Page: 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Qlaira, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets each containing 3 mg estradiol valerate 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest 2 dark red tablets each containing 1 mg estradiol valerate 2 white tablets do not contain active substances Excipient with known effect: lactose (not more than 50 mg per tablet) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Dark yellow film-coated tablet, round with biconvex faces, one side is marked with the letters “DD” in a regular hexagon Medium red film-coated tablet, round with biconvex faces, one side is marked with the letters “DJ” in a regular hexagon Light yellow film-coated tablet, round with biconvex faces, one side is marked with the letters “DH” in a regular hexagon Dark red film-coated tablet, round with biconvex faces, one side is marked with the letters “DN” in a regular hexagon White film-coated tablet, round with biconvex faces, one side is marked with the letters “DT” in a regular hexagon 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. Page: 2 of 22 Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The decision to prescribe Qlaira should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Qlaira compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Oral use POSOLOGY HOW TO TAKE QLAIRA Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. T Read the complete document