Yaz plus tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

pink tablet-drospirenone, ethinyl estradiol, levomefolate (levomefolate calcium); light orange tablet-levomefolate (levomefolate calcium)

Доступна с:

Bayer Weimar GmbH & Co. KG

код АТС:

G03AA12

ИНН (Международная Имя):

pink tablet-drospirenone, ethinyl estradiol, levomefolate (levomefolate calcium); light orange tablet-levomefolate (levomefolate calcium)

дозировка:

pink tablet-3mg+ 0,02mg+ 0,451mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

light orange tablet-0,451mg; (28/24 pink tablet+4light orange tablet/), in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2019-09-25

Характеристики продукта

NDA 22532 Yaz Plus FDA Approved Clean 14Aug2017
1
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 diseases (4)
