Femoston 2/10

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

pink tablet- estradiol, yellow tablet- estradiol + dydrogesterone

Доступна с:

ABBOTT Biologicals B.V.

ИНН (Международная Имя):

pink tablet- estradiol, yellow tablet- estradiol + dydrogesterone

дозировка:

2mg+2mg+10mg

Фармацевтическая форма:

tablets film-coated

Тип рецепта:

Prescription

Характеристики продукта

SUMMRY OF PRODUCT CHARACTERISTIC
1.
NAME OF THE MEDICINAL PRODUCT
Femoston, 2mg/10mg film-coated tablets,
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femoston 2mg/10mg
14 tablets, each containing 2 mg 17

-estradiol (as hemihydrate) and 14 tablets, each
containing 2 mg 17

-estradiol (as hemihydrate) and 10 mg dydrogesterone.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex tablets marked 379 on one side.
Brick red 2 mg tablets and yellow 2/10 mg tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
hormone
replacement
therapy
(HRT)
disorders
caused
by
deficiency
of
estrogen
in
postmenopausal women whose menstruation ceased not less her 6 months
ago;
-
prevention of postmenopausal osteoporosis in women at high risk of
fractures, in case of
intolerance or contraindications to the use of other drugs for the
prevention of osteoporosis
(see "precautions in medical use").
Experience of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Femoston 2/10: Continuous sequential.
The oestrogen is dosed continuously. The progestogen is added for the
last 14 days of every
28 day cycle, in a sequential manner.
Treatment commences with one brick red tablet daily for the first 14
days followed by one
yellow tablet daily for the next 14 days, as directed on the 28 day
calendar pack.
Femoston should be taken continuously without a break between packs.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective
dose for the shortest duration (see also section 4.4) should be used.
In general, sequential combined treatment should start with Femoston
1/10.
SUMMRY OF PRODUCT CHARACTERISTIC
Depending on the clinical response, the dosage can subsequently be
adjusted.
Patients changing from another continuous sequential or cyclical
preparation should complete
the 28 day cycle and then change to Femoston.
Patients changing from a contin