Yarina Plus 3mg+30mcg+451mcg tablets film-coated

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

drospirenone, ethinylestradiol, levomefolate calcium

Sẵn có từ:

Bayer Weimar GmbH & Co. KG

Mã ATC:

G03AA12

INN (Tên quốc tế):

drospirenone, ethinylestradiol, levomefolate calcium

Liều dùng:

3mg+30mcg+451mcg

Dạng dược phẩm:

tablets film-coated

Các đơn vị trong gói:

(28/21+7/) (orange and light orange) in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2018-07-31

Tờ rơi thông tin

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Đặc tính sản phẩm

HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YARINA PLUS SAFELY AND EFFECTIVELY.SEE FULL PRESCRIBING INFORMATION
FOR
YARINA PLUS.
YARINA PLUS(drospirenone/ethinyl estradiol/levomefolate calciumtablets
and levomefolate calciumtablets), 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 YARINA PLUS.
(4)

CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR
EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
------------------------------RECENT MAJOR
CHANGES----------------------
Contraindications (4)
x/201x
Warnings and Precautions (5.5)
MM/YY
----------------------------INDICATIONS AND
USAGE---------------------------
Yarina Plus is an estrogen/progestin COC containing a folate,
indicated for
use by women to:

Prevent pregnancy. (1.1)

Raisefolate levels in women who choose to use an oral contraceptive
for
contraception. (1.2)
---------------------DOSAGE AND ADMINISTRATION----------------------

Take one tablet daily by mouth at the same time everyday. (2.1)

Tablets must be taken in the order directed on the blister pack. (2.1)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Yarina Plus consists of 28 film-coated, biconvex tablets in the
following order
(3):

21 orange tablets, each containing3 mg drospirenone (DRSP), 0.03 mg
ethinyl estradiol (EE)as betadex clathrate and 0.451 mg levomefolate
calcium,

7 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)

Undiagnosed abnormal uterine bleeding (4)

Breast cancer or other estrogen- or progestin-sensitive cancer (4)

Liver tumors or liver disease (4)

Pregnancy (4)