Ethinyloestradiol

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Ethinylestradiol 0.01mg

Tilgængelig fra:

New Zealand Medical & Scientific Ltd

INN (International Name):

Ethinylestradiol 0.01 mg

Dosering:

0.01 mg

Lægemiddelform:

Tablet

Sammensætning:

Active: Ethinylestradiol 0.01mg Excipient: Acacia Alginic acid Ethanol Lactose monohydrate Magnesium stearate Potato starch Water

Enheder i pakken:

Bottle, plastic, 100 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Sanofi Chimie

Terapeutiske indikationer:

Postmenopausal symptoms due to oestrogen deficiency including prevention of postmenopausal osteoporosis. In women with an intact uterus the addition of a progestogen is essential

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap with two piece induction seal foil wad - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Autorisation dato:

1969-12-31

Produktets egenskaber

NEW ZEALAND DATASHEET
1. PRODUCT NAME
Ethinyloestradiol tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ethinyloestradiol 10mcg.
For excipients see 6.1.
3. PHARMACEUTICAL FORM
Round white biconvex unscored tablets.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Postmenopausal
symptoms
due
to
oestrogen
deficiency
including
prevention
of
postmenopausal
osteoporosis.
In
women
with
an
intact
uterus
the
addition
of a
progestogen is essential.
Treatment of metastatic breast cancer in postmenopausal women.
Treatment of prostatic cancer.
4.2 Dose and method of administration
This will depend on the particular indication used, but treatment
should be undertaken with
as low a dose as possible and for as short a period as is necessary.
_ _
_Post _
_menopausal _
_symptoms _
_due _
_to _
_oestrogen _
_deficiency _
_including _
_prevention _
_of _
_postmenopausal osteoporosis:_ the usual dose range is 0.01-0.05mg
daily, usually on a
cyclical basis (e.g. 3 weeks on and 1 week off).
For
women
without
a
uterus,
who
did
not
have
endometriosis
diagnosed,
it
is
not
recommended to add a progestogen.
In women with an intact uterus (or in endometriosis when endometrial
foci may be present
despite hysterectomy), where a progestogen is necessary, it should be
added for at least
12–14 days every month/28 day cycle to reduce the risk to the
endometrium.
The benefits
of
the
lower
risk
of
hyperplasia and endometrial
cancer
due to adding
progestogen should be weighed against the increased risk of breast
cancer (see Warnings
and Precautions, and Adverse Effects).
Therapy with ethinyloestradiol tablets may start at any time in women
with established
amenorrhoea or who are experiencing long intervals between spontaneous
menses. In
women who are menstruating, it is advised that therapy starts on the
first day of bleeding. As
ethinyloestradiol tablets are usually taken on a cyclical basis direct
switching from other
oestrogen-only HRT preparations taken cyclically is possible.
_ _
_Treatment of prostatic cancer:_ 1-2mg daily.
4.3 Contra