Zoladex 10.8mg

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Goserelin acetate 11.34mg equivalent to 10.8 mg goserelin;  

Available from:

AstraZeneca Limited

INN (International Name):

Goserelin acetate 11.34 mg (equivalent to 10.8 mg goserelin)

Dosage:

10.8 mg

Pharmaceutical form:

Injection (depot)

Composition:

Active: Goserelin acetate 11.34mg equivalent to 10.8 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 10.8 mg is indicated for the management of: 1. Prostate cancer suitable for hormonal manipulation.

Product summary:

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

Authorization date:

1995-02-13

Patient Information leaflet

Zoladex® 10.8 mg CMI 080520
Copyright
1(6)
ZOLADEX
®
10.8 MG
GOSERELIN ACETATE, 10.8 MG, INJECTABLE IMPLANT
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
ZOLADEX 10.8. It does not
contain all the information that is known about ZOLADEX 10.8.
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 10.8 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 10.8 IS USED FOR
ZOLADEX 10.8 is a special preparation of goserelin acetate which is
designed to work in the body for
12 to 13 weeks after each injection. Most people will need one
injection for each 12 to 13 weeks of
treatment. ZOLADEX 10.8 is otherwise similar to Zoladex 3.6 mg which
you may have received in the
past. Zoladex 3.6 mg lasts for only 28 days.
ZOLADEX 10.8 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 10.8 lowers sex hormones, all these actions will be
reduced. Due to the action of
ZOLADEX 10.8 on hormones, ZOLADEX 10.8 can treat very different
illnesses in both men and women.
_ _
_MEN: _
_PROSTATE CANCER _
ZOLADEX 10.8 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: _
_ENDOMETRIOSIS _
For endometriosis, ZOLADEX 10.8 may be used instead of

Summary of Product characteristics

Z
OLADEX
10.8 mg Data Sheet 080520
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1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Z
OLADEX
®
10.8 mg Depot Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin (present as goserelin acetate) 10.8 mg injection.
3.
PHARMACEUTICAL FORM
Injection (depot)
A sterile, white to cream coloured cylindrical depot in which
goserelin acetate (equivalent to
10.8 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
10.8
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.
Endometriosis: Z
OLADEX
alleviates symptoms including pain, and reduces the size and
number of endometrial lesions.
4.
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.
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.
Use extra care when administering Z
OLADEX
to patients with a low BMI and/or who are
receiving full anticoagulation medication (see section 4.4).
Z
OLADEX
10.8 mg Data Sheet 080520
Copyright
2
For correct administration of Z
OLADEX
, see instructions on the administration card (also see
Method of administration below).
ADULT MEN
One depot of Z
OLADEX
10.8 mg injected subcutaneously into the anterior abdominal wall every
3 months.
Adjuvant and/or neoadjuvant Z
OLADEX
therapy in combination with radio