Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
(Tablet core, Product) Drospirenone; (Tablet core, Product) Ethinylestradiol betadex clathrate
BAYER (SOUTH EAST ASIA) PTE LTD
G03AA12
3.000 mg
TABLET, FILM COATED
(Tablet core, Product) Drospirenone 3.000 mg; (Tablet core, Product) Ethinylestradiol betadex clathrate 0.020 mg
ORAL
Prescription Only
BAYER WEIMAR GMBH UND CO. KG
ACTIVE
2008-12-15
YAZ Package Insert Page 1 of 20 Yaz PI_SG_CCDS 15 (not inclusive of CCDS 14)_ 4 Aug 2014 1. NAME OF THE MEDICINAL PRODUCT Yaz 0.02mg/3mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 24 hormone-containing light pink film-coated tablets: Each film-coated tablet contains 0.02 mg ethinylestradiol (as betadex clathrate), 3 mg drospirenone. 4 hormone-free white film-coated tablets. For a full list of excipients(s), see section, “List of excipients”. 3. PHARMACEUTICAL FORM Film-coated tablet. The hormone-containing tablet is light pink, round with convex faces, one side marked with the letters "DS" in a regular hexagon. The hormone-free tablet is white, round with convex faces, one side marked with the letters "DP" in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 INDICATIONS YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. YAZ is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. YAZ is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Oral use 4.2.2 DOSAGE REGIMEN HOW TO TAKE YAZ; 24 + 4 FILM-COATED TABLETS Combined oral contraceptives, Izlasiet visu dokumentu
Yaz PI_SG_CCDS 18 (not inclusive of CCDS 14)_ 15 Nov 2016 Page 1 of 21 RESTRICTED 1. NAME OF THE MEDICINAL PRODUCT Yaz 0.02mg/3mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 24 hormone-containing light pink film-coated tablets: Each film-coated tablet contains 0.02 mg ethinylestradiol (as betadex clathrate), 3 mg drospirenone. 4 hormone-free white film-coated tablets. For a full list of excipients(s), see section, “List of excipients”. 3. PHARMACEUTICAL FORM Film-coated tablet. The hormone-containing tablet is light pink, round with convex faces, one side marked with the letters "DS" in a regular hexagon. The hormone-free tablet is white, round with convex faces, one side marked with the letters "DP" in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 INDICATIONS YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. YAZ is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. YAZ is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Oral use 4.2.2 DOSAGE REGIMEN HOW TO TAKE YAZ; 24 + 4 FILM-COATED TABLETS Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. Yaz PI_SG_CCDS 18 (not inclusive of CCDS 14)_ 15 Nov 2016 Page 2 of 21 RESTRICTED Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is to be t Izlasiet visu dokumentu