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

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

drospirenone, ethinylestradiol, levomefolate calcium

MAH:

Bayer Weimar GmbH & Co. KG

ATC_code:

G03AA12

INN:

drospirenone, ethinylestradiol, levomefolate calcium

dosage:

3mg+30mcg+451mcg

pharmaceutical_form:

tablets film-coated

units_in_package:

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

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2018-07-31

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SPC

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)