OESTRODOSE 0.06% GEL

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

ESTRADIOL HEMIHYDRATE (ESTRADIOL)

Disponível em:

SYARIKAT WELLCHEM SDN. BHD.

DCI (Denominação Comum Internacional):

ESTRADIOL HEMIHYDRATE (ESTRADIOL)

Unidades em pacote:

80 gm

Fabricado por:

LABORATOIRES BESINS INTERNATIONAL

Folheto informativo - Bula

OESTRODOSE GEL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Estradiol Hemihydrate (60mg/100g)
WHAT IS IN THIS LEAFLET
1.
What Oestrodose is used for
2.
How Oestrodose works
3.
Before you use
Oestrodose
4.
How to use Oestrodose
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Oestrodose
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT OESTRODOSE IS USED FOR
Oestrodose is used for general
estrogen therapy that is absorbed
through the skin. It contains the
female hormone oestrogen.
Oestrodose is indicated for
estrogen deficiency, following the
decrease in ovarian activity:
-
Blood vessels constriction
dilation disorders, hot flushes.
-
Vaginal dryness and thinning
of vaginal wall which may
disrupt sexual intercourse.
HOW OESTRODOSE WORKS
Oestrodose works by replacing the
oestrogen in your body.
BEFORE YOU USE OESTRODOSE
-
_When you must not use it _
Do not take Oestrodose:
-
If you are allergic to estradiol or
any of the other ingredients of
this medicine.
-
If you are pregnant.
-
If you have malignant tumors of
the breast or uterus, pituitary
tumors.
-
If you have severe liver, kidney
or heart disease, porphyria (a
group of diseases in which
substances called porphyrins
build up, affecting the skin or
nervous system)
, blood
circulation disorders such as
blood clots in the veins of the
legs or the lungs or a confirmed
history of these conditions.
-
If you have undiagnosed
vaginal bleeding.
A complete medical and family
history should be obtained prior to
starting any estrogen therapy.
Before commencing therapy, you
should have a complete physical and
gynaecological examination including
blood pressure, breasts, abdomen and
pelvic organs and endometrial
assessment where necessary. This
should be repeated at regular intervals.
People with a uterus should be
monitored at least annually for signs
of thickening of uterus lining or
endometrial cancer.
Women who have not had their uterus
removed. The addition of 10 or more
days of progesterone s

Características técnicas

OESTRODOSE 0.06% GEL
Metered dose pump
_FOR TOPICAL ADMINISTRATION _
_ACTIVE INGREDIENT _
This canister delivers 64 metered doses.
Each metered dose (1.25g gel) contains 0.75mg 17

-
estradiol.
_OTHER INGREDIENTS:_ Carbomer, 95% v/v ethanol,
triethanolamine and purified water.
_PRODUCT DESCRIPTION:_ Container with pump and cap
containing a colourless, transparent gel with an
alcoholic odour.
_MODE OF ACTION: _
General estrogen therapy via the percutaneous route:
Uses the natural estrogen secreted by the ovary: 17

-
estradiol
_PHARMACOLOGY: _

General estrogen therapy by the
percutaneous route, with the following
advantages: Use of the estrogen naturally
secreted by the ovary, named estradiol 17

;

Avoids the effects of first passage through the
liver, which increases angiotensinogen
synthesis, VLDL lipoproteins and certain
clotting factors considered to favour the
development of cardiovascular,
thromboembolic and metabolic side-effects.
_PHARMACOKINETIC PROPERTIES: _
Percutaneous absorption equal to around 10% of the
dose applied: one metered dose delivered 75

g of
estradiol. There is a transitory stockage in the corneal
of the epidermis. There is slow diffusion into the
general circulation via the dermic capillary bed. The
plasma level of 17

-estradiol obtained in menopausal
women receiving 2 measures per day of Oestrodose is
on average 80 pg/ml. The estrone/ estradiol ratio is
similar to that seen in non-menopausal genitally active
women.
_INDICATIONS: _
Indicated in estrogen deficiency following the decrease
in ovarian activity:
-
Vasomotor disorders, hot flushes
-
Vaginal atrophy and dryness which may
disrupt sexual intercourse
_RECOMMENDED DOSE: _
Posology and method of administration:
OESTRODOSE is presented in bottles supplied with a
metered dose pump.
Each pressure dose delivers 1.25 gm of gel, containing
0.75 mg of estradiol
The mean dose is 2.5 gm of gel per day, i.e. 2 pressure
doses for a period of 24 to 28 days.
The posology may be readjusted after 2 or 3 cycles of
treatment