EVOREL 50

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

ESTRADIOL AS HEMIHYDRATE

Mevcut itibaren:

TRUEMED LTD.

ATC kodu:

G03CA03

Farmasötik formu:

PATCHES

Kompozisyon:

ESTRADIOL AS HEMIHYDRATE 3.2 MG

Uygulama yolu:

TRANSDERMAL

Reçete türü:

Required

Tarafından üretildi:

THERAMEX IRELAND LIMITED, IRELAND

Terapötik alanı:

ESTRADIOL

Terapötik endikasyonlar:

Deficiency symptoms by absence of Estrogen after the menopause or after surgical removal of the ovarians. They comprise hot flushes, insomnia, atrophies of the urogenital system, changes of mood and increasing loss of the bone substance, which can lead to osteoporosis. In women with intact uterus, estrogen substitution must always be supplemented with a sequential gestagen therapy.

Yetkilendirme tarihi:

2021-11-30

Bilgilendirme broşürü

Page 1 of 13
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Evorel 50
Transdermal patch
Active ingredient and its quantity in a dosage unit:
estradiol (as hemihydrate) 3.2 mg
The transdermal patch delivers 50 mcg estradiol per day.
Inactive ingredients and allergens in the medicine - see section 6
"Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
To treat symptoms related to oestrogen deficiency in women after
menopause or after surgical
removal of the ovaries. The symptoms include hot flushes, insomnia,
changes in the urogenital
system, mood changes and bone loss, which may lead to osteoporosis.
In women who have not undergone hysterectomy, oestrogen therapy must
be supplemented
with sequential gestagen therapy.
THERAPEUTIC GROUP:
estradiol
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to estradiol or to any of the other
ingredients in this
medicine (as listed in section 6 "Additional information")
•
You have, have previously had or are suspected of having
BREAST CANCER
•
You have or are suspected of having
A CANCEROUS TUMOUR WHICH IS WORSENED BY
OESTROGENS
(such as endometrial cancer)
•
You have untreated
THICKENING OF THE LINING OF THE WOMB
(endometrial hyperplasia)
•
You have
UNEXPLAINED VAGINAL BLEEDING
•
You have or have previously had
BLOOD CLOTS IN THE VEINS
(thrombosis), such as in
the legs (deep venous thrombosis) or lungs (pulmonary embolism)
•
You have a
BLOOD CLOTTING DISORDER
(such as protein C, protein S or antithrombin
deficiency)
•
You have or have previously h

Ürün özellikleri

1.
NAME OF THE MEDICINAL PRODUCT
Evorel
®
50
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
3.2 mg
of
estradiol
(as hemihydrate) /patch
3.
PHARMACEUTICAL FORM
Transdermal patch
EVOREL is a square shaped, transparent, self-adhesive transdermal
delivery system (patch)
of 0.2 mm thickness for application to the skin surface.
It consists of a monolayered adhesive matrix throughout which 17β
estradiol is uniformly
distributed. The adhesive matrix is protected on the outside surface
(from clothes etc) by a
polyethylene teraphthalate backing foil, while the adhesive surface of
the patch is covered by
a polyester sheet (the release liner) which is removed before placing
the patch on the body
surface. This release liner has an S-shaped incision which facilitates
easy removal from the
patch.
EVOREL 50 is marked ‘CE50’, has a surface area of 16 sq. cm and
contains 3.2 mg estradiol
(as hemihydrate) corresponding to a release rate of 50 micrograms of
estradiol in 24 hours.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deficiency symptoms by absence of Estrogen after the menopause or
after surgical removal of
the ovarians. They comprise hot flushes, insomnia, atrophies of the
urogenital system,
changes of mood and increasing loss of the bone substance, which can
lead to osteoporosis.
In women with intact uterus, estrogen substitution must always be
supplemented with a
sequential gestagen therapy.
4.2
POSOLOGY AND
METHOD OF
ADMINISTRATION
_ADULTS_
Evorel is an oestrogen-only HRT patch applied to the skin twice
weekly.
For initiation and continuation of treatment of menopausal symptoms,
the lowest
effective dose for the shortest duration (see also Section 4.4) should
be used.
For women with an intact uterus progestogen should normally be added
to Evorel
for the prevention of adverse endometrial effects, e.g. hyperplasia
and cancer. The
regimen may be either cyclic or continuous sequential.
Only progestogens approved for addition to oestrogen treatment may be
prescribed
(e.g. oral norethisterone, 1mg/day or medroxyproges