Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pink tablet-drospirenone, ethinyl estradiol, levomefolate (levomefolate calcium); light orange tablet-levomefolate (levomefolate calcium)
Bayer Weimar GmbH & Co. KG
G03AA12
pink tablet-drospirenone, ethinyl estradiol, levomefolate (levomefolate calcium); light orange tablet-levomefolate (levomefolate calcium)
pink tablet-3mg+ 0,02mg+ 0,451mg
tablets film-coated
light orange tablet-0,451mg; (28/24 pink tablet+4 light orange tablet/), in blister
Prescription
Registered
2020-09-05
NDA 22532 Yaz Plus FDA Approved Clean 14Aug2017 1 RESTRICTED HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE YAZ PLUS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YAZ PLUS. YAZ PLUS (DROSPIRENONE/ETHINYL ESTRADIOL/ LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS), FOR ORAL USE INITIAL U.S. APPROVAL: 2010 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE YAZ PLUS. (4) CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4) ----------------------------INDICATIONS AND USAGE--------------------------- Yaz Plus is an estrogen/progestin COC containing a folate, indicated for use by women to: Prevent pregnancy. (1.1) Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2) Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3) Raise folate levels in women who choose to use an oral contraceptive for contraception. (1.4) ----------------------DOSAGE AND ADMINISTRATION----------------------- Take one tablet daily by mouth at the same time every day. (2.1) Tablets must be taken in the order directed on the blister pack. (2.1) ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Yaz Plus consists of 28 film-coated, biconvex tablets in the following order (3): 24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg ethinyl estradiol (EE) as betadex clathrate and 0.451 mg levomefolate calcium 4 light orange tablets, each containing 0.451 mg levomefolate calcium -------------------------------CONTRAINDICATIONS------------------------------ Renal impairment (4) Adrenal insufficiency (4) A high risk of arterial or venous thrombotic diseas Lugege kogu dokumenti