QLAIR

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE

זמין מ:

BAYER ISRAEL LTD

קוד ATC:

G03CA03

טופס פרצבטיות:

FILM COATED TABLETS

הרכב:

ESTRADIOL VALERATE 1 MG; ESTRADIOL VALERATE 3 MG; DIENOGEST 2 MG; DIENOGEST 3 MG; ESTRADIOL VALERATE 2 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

קבוצה תרפויטית:

ESTRADIOL

איזור תרפויטי:

ESTRADIOL

סממני תרפויטית:

Oral contraception.Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.

תאריך אישור:

2016-04-30

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
QLAIR
film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each wallet (28 film-coated tablets) contains in the following order:
2 dark yellow tablets each containing 3 mg estradiol valerate
5 medium red tablets each containing 2 mg estradiol valerate and 2 mg
dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and 3
mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets do not contain active substances
Excipient with known effect: lactose monohydrate 48.36, 47.36, 46.36,
50.36, 52.1455
mg, respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Dark yellow film-coated tablet, round with biconvex faces, one side is
marked
with the
letters “DD” in a regular hexagon
Medium red film-coated tablet, round with biconvex faces, one side is
marked
with the
letters “DJ” in a regular hexagon
Light yellow film-coated tablet, round with biconvex faces, one side
is
marked
with the
letters “DH” in a regular hexagon
Dark red film-coated tablet, round with biconvex faces, one side is
marked
with the letters
“DN” in a regular hexagon
White film-coated tablet, round with biconvex faces, one side is
marked
with the letters
“DT” in a regular hexagon
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
Treatment of heavy menstrual bleeding in women without organic
pathology who desire
oral contraception.
The decision to prescribe Qlair should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the
risk of VTE with Qlair compares with other combined hormonal
contraceptives (CHCs)
(see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Oral use
POSOLOGY
HOW TO TAKE QLAIR
Tablets must be taken in the order directed on the package every day
at about the same
time with some liquid as needed. Tablet tak