Zoladex 3.6mg

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Goserelin acetate 3.8mg equivalent to 3.6 mg goserelin;  

Available from:

AstraZeneca Limited

INN (International Name):

Goserelin acetate 3.8 mg (equivalent to 3.6 mg goserelin)

Dosage:

3.6 mg

Pharmaceutical form:

Injection (depot)

Composition:

Active: Goserelin acetate 3.8mg equivalent to 3.6 mg goserelin   Excipient: Polyglactin

Units in package:

Syringe, depot implant, 1 implant

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

AstraZeneca UK Ltd

Therapeutic indications:

ZOLADEX 3.6 mg is indicated for the management of: 1. Prostate cancer suitable for hormonal manipulation.

Product summary:

Package - Contents - Shelf Life: Syringe, depot implant physician sample pack - 1 implants - 36 months from date of manufacture stored at or below 25°C - Syringe, depot implant - 1 implants - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1987-04-30

Patient Information leaflet

Zoladex® 3.6 mg CMI 080520
Copyright
1(7)
ZOLADEX
®
3.6 MG
GOSERELIN ACETATE, 3.6 MG, INJECTABLE IMPLANT
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
ZOLADEX 3.6. It does not
contain all the information that is known about ZOLADEX 3.6.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking
ZOLADEX 3.6 against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT ZOLADEX 3.6 IS USED FOR
ZOLADEX 3.6 is a special preparation of goserelin acetate which is
designed to work in the body for 28
days after each injection. ZOLADEX 3.6 is a member of the
anti-hormonal group of medicines. This
means that it affects the levels of various hormones (natural
chemicals produced by the body). In
men it will reduce levels of the male hormone, testosterone. In women
it will reduce the levels of the
female hormone, oestrogen.
In women, female hormones make the breasts grow, prepare the womb and
other sex organs for
pregnancy, and increase the sex drive.
In men, male hormones make the testicles grow, assist an erection, and
increase the sex drive.
When ZOLADEX 3.6 lowers sex hormones, all these actions will be
reduced. Due to the action of
ZOLADEX 3.6 on hormones, ZOLADEX 3.6 can treat very different
illnesses in both men and women.
_ _
_MEN: _
_PROSTATE CANCER _
ZOLADEX 3.6 can treat prostate cancer in some men. It is not a cure
for prostate cancer, and does not
work in every patient with prostate cancer.
_WOMEN_:
_BREAST CANCER _
ZOLADEX 3.6 is used to treat hormone sensitive breast cancer in women
before menopause. It is not a
cure for breast cancer. It can often keep the cancer controlled for a
period of time.
_ENDOMETRIOSIS _
For endometriosis, ZOLADEX 3.6 may be used instead of surgery. ZOLADEX
3.6 is

Summary of Product characteristics

Z
OLADEX
®
3.6 mg Data Sheet 080520
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Z
OLADEX
®
3.6 mg Depot Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin (present as goserelin acetate) 3.6 mg injection.
3.
PHARMACEUTICAL FORM
Injection (depot)
A sterile, white to cream coloured cylindrical implant in which
goserelin acetate (equivalent to
3.6 mg of peptide base) is dispersed in a biodegradable matrix. It is
supplied in a single dose
syringe
applicator.
The
SafeSystem
TM
incorporates
a
protective
needle
sleeve
that
automatically locks in place following administration of the implant
to aid in the prevention of
needle stick injury.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Z
OLADEX
3.6 mg is indicated for the management of:
1.
Prostate cancer suitable for hormonal manipulation.
2.
Adjuvant and neoadjuvant therapy in combination with radiotherapy for
the management
of locally advanced prostate cancer in men suitable for hormonal
manipulation.
3.
Pre- and peri-menopausal women with hormone receptor positive breast
cancer suitable
for hormonal manipulation.
4.
Endometriosis:- Z
OLADEX
alleviates symptoms including pain, and reduces the size and
number of endometrial lesions.
5.
Uterine fibroids:- Z
OLADEX
shrinks the lesions, reduces symptoms including pain, and
causes cessation of menses in the majority of patients thereby
improving haematological
status when previous heavy menstrual loss has caused anaemia.
6.
Endometrial thinning:- Use as an endometrial thinning agent prior to
endometrial ablation.
As a prethinning agent Z
OLADEX
3.6 mg should be administered as two implants, four
weeks apart, with surgery planned for between zero and two weeks after
the second
implant injection.
7.
Assisted reproduction:- Pituitary down regulation in preparation for
superovulation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Caution should be taken while inserting Z
OLADEX
into the anterior abdominal wall due to the
proximity of underlying inferior epigastric artery and its branches.
Z
OLADEX
®
3.6 mg D