DIVIGEL GEL 1mgdose

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Estradiol Hemihydrate eqv Estradiol

Fáanlegur frá:

ORION PHARMA (SG) PTE. LTD.

ATC númer:

G03CA03

Skammtar:

1 mg

Lyfjaform:

GEL

Samsetning:

Estradiol Hemihydrate eqv Estradiol 1 mg/dose

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Orion Corporation, Orion Pharma

Leyfisstaða:

ACTIVE

Leyfisdagur:

2001-08-22

Vara einkenni

1.
DIVIGEL 0.1 % GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT AND EXCIPIENTS
Estradiol hemihydrate corresponding to 1.0 mg estradiol per
single-dose container
Estradiol hemihydrate corresponding to 0.5 mg estradiol per
single-dose container
Excipients with known effect
One gram of gel contains 125 mg propylene glycol and 585 mg ethanol
(96%).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORMS
Gel, single-dose aluminium sachet
Smooth and opalescent gel
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the climacteric syndrome associated with natural or
artificial menopause (estrogenic
deficiency, e.g. hot flushes, night sweatings, urogenital atrophy and
prevention of postmenopausal
(type 1) osteoporosis).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Divigel can be used for continuous or cyclical treatment.
The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily but the
selection of the initial dose can be
based on the severity of the patient’s symptoms. Depending on the
clinical response, the dosage can be
readjusted after 2–3 cycles individually from 0.5 g to 1.5 g per
day, corresponding to 0.5 to 1.5 mg
estradiol per day.
In patients with an intact uterus, it is necessary to combine Divigel
with an adequate dose of progestin
for adequate duration, at least 12–14 consecutive days per month/28
day cycle or to oppose estrogen-
stimulated hyperplasia of the endometrium.
Unless there is a previous diagnosis of endometriosis, it is not
recommended to add a progestin in
hysterectomised women.
Estrogen with or without progestogens should be prescribed at the
lowest effective doses and for
the shortest duration consistent with treatment goals and risks for
the individual women.
Method of administration
Apply on dry and clean skin.
The Divigel dose is applied once daily, on the skin of the lower trunk
or the right or left thighs, on
alternate days. The application surface should be 1-2 times the size
of the hand. Divigel should
not be applied on