FEMOSTON 210 TABLET

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Dydrogesterone, micronized (in yellow tablet); ESTRADIOL HEMIHYDRATE 2.06 mg EQV ESTRADIOL (Micronised) (in Brick Red Tablet); ESTRADIOL HEMIHYDRATE 2.06 mg EQV ESTRADIOL (Micronised) (in Yellow Tablet)

Commercializzato da:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Codice ATC:

G03FA14

Dosaggio:

10 mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

Dydrogesterone, micronized (in yellow tablet) 10 mg; ESTRADIOL HEMIHYDRATE 2.06 mg EQV ESTRADIOL (Micronised) (in Brick Red Tablet) 2 mg; ESTRADIOL HEMIHYDRATE 2.06 mg EQV ESTRADIOL (Micronised) (in Yellow Tablet) 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Abbott Biologicals B.V.

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

1997-11-11

Scheda tecnica

1
_FEMOSTON_
_® _
_FILM-COATED TABLETS _
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Femoston
_®_
_ _
Conti 1/5 film-coated tablets
Femoston
_®_
_ _
1/10 film-coated tablets
Femoston
_®_
_ _
2/10 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femoston
_®_
_ _
Conti 1/5 Tablet
28 tablets, each containing 1 mg 17ß-estradiol (as hemihydrate) and 5
mg dydrogesterone.
Femoston
_®_
_ _
1/10 Tablet
14 tablets, each containing 1 mg 17ß-estradiol (as hemihydrate) and
14 tablets, each containing 1 mg 17ß-
estradiol (as hemihydrate) and 10 mg dydrogesterone.
Femoston
_®_
_ _
2/10 Tablet
14 tablets, each containing 2 mg 17ß-estradiol (as hemihydrate) and
14 tablets, each containing 2 mg 17ß-
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.
Femoston
_®_
_ _
Conti 1/5
Salmon-coloured 1/5 mg tablets.
Femoston
_®_
_ _
1/10
White 1 mg tablets and grey 1/10 mg tablets.
Femoston
_®_
_ _
2/10
Brick red 2 mg tablets and yellow 2/10 mg tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For continuous combined HRT regimen: Femoston
_®_
_ _
Conti 1 /5
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women with
a uterus, at least 12 months since last menses.
Prevention of osteoporosis in postmenopausal women with a uterus, at
high risk of future fractures who are
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of osteoporosis.
2
For continuous sequential HRT regimen: Femoston
_®_
_ _
1/10
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.
For continuous sequen