ZOLADEX

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

GOSERELIN AS ACETATE

Dostępny od:

ASTRAZENECA (ISRAEL) LTD

Kod ATC:

L02AE03

Forma farmaceutyczna:

IMPLANT

Skład:

GOSERELIN AS ACETATE 3.6 MG/UNIT

Droga podania:

S.C

Typ recepty:

Required

Wyprodukowano przez:

ASTRA ZENECA UK LIMITED

Grupa terapeutyczna:

GOSERELIN

Dziedzina terapeutyczna:

GOSERELIN

Wskazania:

Treatment of prostate cancer suitable for hormonal manipulation. Breast cancer in pre-menopausal women suitable for hormone manipulation.Endometriosis. Assisted reproduction: pituitary down regulation in preparion for superovulation. Endometrial thinning: Zoladex is indicated for the prethinning of the utetine endometrium prior ro endometrial ablation or resection. Uterine Fibroids: For reduction of fibroid size prior to surgery.

Data autoryzacji:

2023-06-30

Ulotka dla pacjenta

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Zoladex
®
Implant for subcutaneous injection in a pre-filled syringe
Composition:
Each syringe contains:
goserelin (as acetate) 3.6 mg
For inactive ingredients, please see section 6 – "Further
Information".
Read this leaflet carefully in its entirety before using this
medicine.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it
on to others. It may harm them even if it seems to you that their
ailment is similar.
Most of the information in this leaflet applies to women and men.
When the information applies to men only, it will be labeled with the
heading
"Information for men".
When the information applies to women only, it will be labeled with
the heading
"Information for women".
1.
WHAT IS ZOLADEX AND WHAT IT IS INTENDED FOR?
Information for men:
For treatment of prostate cancer. Zoladex works by lowering the levels
of
testosterone, a hormone produced by the body.
Information for women:
In women, Zoladex works by lowering the levels of estrogen, a hormone
produced by
the body.
•
For treatment of breast cancer in premenopausal women.
•
For treatment of endometriosis – a disease of the womb lining (a
condition
where pain is caused by excess tissue which grows within or outside of
the
womb).
•
Helps fertility by preparing for superovulation.
•
Uterine fibroids (benign growths that appear in the womb), to decrease
the
size of fibroids before surgery.
•
Prethinning of the womb lining before surgery.
Therapeutic activity:
Zoladex contains a medicine called goserelin. This belongs to a group
of medicines
called: LHRH analogues.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are sensitive to the active ingredient goserelin or to any of the
other
ingredients of the preparation

Charakterystyka produktu

1. NAME OF THE MEDICINAL PRODUCT
ZOLADEX
R
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate
(equivalent to 3.6 mg goserelin)
For
the full list of
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Implant, in pre-filled syringe.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of prostate cancer suitable for hormonal manipulation.
Breast cancer in pre-
menopausal women suitable for hormone manipulation. Endometriosis.
Assisted reproduction:
pituitary down regulation in preparation for superovulation.
Endometrial thinning: Zoladex is
indicated for the prethinning of the utetine endometrium prior to
endometrial ablation or
resection. Uterine Fibroids: For reduction of fibroid size prior to
surgery.
4.2 Posology and method of administration
Adults
One 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior
abdominal wall, every
28 days. No dosage adjustment is necessary for patients with renal or
hepatic impairment or
in the elderly.
Endometriosis should be treated for a period of six months only, since
at present there are no
clinical data for longer treatment periods. Repeat courses should not
be given due to concern
about loss of bone mineral density. In patients receiving ZOLADEX for
the treatment of
endometriosis, the addition of hormone replacement therapy (a daily
oestrogenic agent and a
progestogenic agent) has been shown to reduce bone mineral density
loss and vasomotor
symptoms.
For use in endometrial thinning, four or eight weeks treatment. The
second depot may be
required for the patient with a large uterus or to allow flexible
surgical timing.
Page 2 of 15
2
For women who are anaemic as a result of uterine fibroids: ZOLADEX 3.6
mg depot with
supplementary iron may be administered for up to three months before
surgery.
Assisted reproduction:
ZOLADEX 3.6 mg is administered to downregulate the pituitary gland, as
defined by serum
oestradiol levels similar to those observed in the early follicular
phase (approximately 150
pmol/l). This will usually take between 7 and 21