Femoston 1/10

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

white tablet - estradiol, gray tablet - estradiol, dydrogesterone

Tilgjengelig fra:

ABBOTT Biologicals B.V.

INN (International Name):

white tablet - estradiol, gray tablet - estradiol, dydrogesterone

Dosering :

1mg+1mg+10mg

Legemiddelform:

tablets film-coated

Resept typen:

Prescription

Preparatomtale

Abbott
Confidential
Information
This information is
confidential
Estradiol - Dydrogesterone
SOLID 1000323709
SUMMARY OF PRODUCT CHARACTERISTICS ESTRADIOL / DYDROGESTERONE
Date of Previous Approval: 15 Jan 2013
Date of Approval: 15 Jan 2016
_ _
_ _
1
NAME OF THE MEDICINAL PRODUCT
Femoston
®
1/10 , 1mg/10mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femoston
®
1/10, 1mg/10mg film-coated tablets
14 tablets, each containing 1 mg 17β -estradiol (as hemihydrate) and
14 tablets, each containing 1 mg
17β -estradiol (as hemihydrate) and 10 mg dydrogesterone.
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex tablets marked 379 on one side.
White 1 mg tablets and grey 1/10 mg tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal
women at least 6 months since last menses.

Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of
osteoporosis.
The experience in treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Femoston
®
1/10, Continuous combined.
For oral use.
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 white
tablet daily for the first 14 days
followed by one grey tablet daily for the next 14 days, as directed on
the 28 day calendar pack.
Femoston
®
1/10 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.
Depending on the clinical response, the dosage can subsequently be
adjusted.
Patients changing from another continuous sequential or cyclical
preparation should complete