Duphaston tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

dydrogesterone

Доступна с:

ABBOTT Biologicals B.V.

код АТС:

G03DB01

ИНН (Международная Имя):

dydrogesterone

дозировка:

10mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(20/1x20/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-04-06

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Duphaston 10, film-coated tablets 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg dydrogesterone
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A round, biconvex, white film-coated tablet, with a score line, with
the inscription ‘155’ on
one side on either side of the score line. The score line is only to
make the tablet easier to
break so that it is easier to swallow; it is not intended for dividing
it into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
To regulate the menstrual cycle
-
Endometriosis
-
Dysmenorrhoea
-
Infertility as a result of corpus luteum insufficiency
-
Luteal support as part of an Assisted Reproductive Technology (ART)
treatment
-
Threatened abortion as a result of progesterone deficiency
-
Habitual abortion as a result of progesterone deficiency
As a cyclical supplement to oestrogen therapy in women with an intact
uterus, Duphaston can
be used:
-
to prevent endometrial hyperplasia in the postmenopausal period
-
for dysfunctional uterine bleeding
-
for secondary amenorrhoea
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The
following
dosage
regimens
are
recommended
for
treatment
with
Duphaston.
The
quantities can be adjusted according to the seriousness of the
disorder to be treated and the
individual patients’ responses to the treatment.
_Regulation of the cycle _
It is possible to achieve a cycle lasting 28 days by giving 1 tablet
of Duphaston a day from the
11
th
to the 25
th
day of the cycle.
_Endometriosis _
1 to 3 tablets of Duphaston a day from the 5
th
to the 25
th
day of the cycle or for the entire
cycle. Dosages of 10 mg several times a day should be spread over the
day. It is recommended
that treatment should start at the highest dose.
_ _
_Dysmenorrhoea _
1 to 2 tablets of Duphaston a day from the 5
th
to the 25
th
day of the cycle. Dosages of 10 mg
several times a day should be spread over the day. It is recommended
t