ZOLADEX 10.8 IMPLANT goserelin 10.8mg (as acetate) implant syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

goserelin, Quantity: 10.8 mg

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Implant

Composition:

Excipient Ingredients: polyglactin

Administration route:

Subcutaneous

Units in package:

1 syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prostate Cancer: Palliative treatment of metastatic or locally advanced prostate cancer , where suitable for hormonal manipulation. Adjuvant and neo-adjuvant therapy in combination with radiotherapy for the management of locally advanced prostate cancer in men suitable for hormonal manipulation.

Product summary:

Visual Identification: White to cream coloured cylindrical pieces of rigid polymeric material which are free or practically free from visible impurities.; Container Type: Syringe; Container Material: Plastic; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1996-05-22

Patient Information leaflet

ZOLADEX
®
10.8MG
IMPLANT SAFESYSTEM™
_Goserelin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
ZOLADEX 10.8mg implant. It does
not contain all the information that is
known about ZOLADEX 10.8mg.
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 10.8mg 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 IS FOR
ZOLADEX can treat prostate cancer
in some men. It is not a cure for
prostate cancer. ZOLADEX lowers
the amount of sex hormones in the
body. In men it reduces the level of
testosterone.
Your doctor will have explained why
you are being treated with
ZOLADEX 10.8mg and told you
what dose you will be given.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
ZOLADEX 10.8mg is not addictive.
BEFORE YOU ARE GIVEN
ZOLADEX 10.8MG
_WHEN YOU MUST NOT BE GIVEN_
_IT_
ZOLADEX 10.8MG WILL NOT
NORMALLY BE USED IN FEMALES.
There is not enough evidence to
support its use in women.
ZOLADEX 10.8MG WILL NOT BE
GIVEN TO CHILDREN.
There is no information on its use in
children.
IT WILL NOT BE USED AFTER THE USE BY
(EXPIRY) DATE PRINTED ON THE PACK.
It may have no effect at all, or worse,
an entirely unexpected effect if it is
used it after the expiry date.
ZOLADEX 10.8MG WILL NOT BE
USED IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
_BEFORE YOU START TO USE IT_
YOU MUST TELL YOUR DOCTOR IF:
•
you have allergies to any
ingredients listed at the end of
this leaflet or any other
substances
If you have an allergic reaction, you
may get a rash, hay fever, difficulty
breathing or feel fa

Summary of Product characteristics

ZOLADEX 10.8 mg IMPLANT Product Information
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ZOLADEX 10.8 MG IMPLANT
goserelin
PRODUCT INFORMATION
NAME OF THE MEDICINE
Goserelin acetate. It is a Gonadotrophin Releasing Hormone Agonist
(GnRH
Agonist) - [also known as Luteinising Hormone Releasing Hormone
Agonist
(LHRH Agonist)].
CHEMICAL STRUCTURE:
Structural Formula:
N
H
N
H
N
H
N
H
N
H
N
H
N
H
O H
N H
N H
2
N
H
N H
O
N H
O H
N
N
H
N
H
N H
2
O
O
O
O
O
O
O
O
O
O
N
N H
O t
B
u
Goserelin acetate
HOAc
CAS Registry Number: 65807-02-5 (Goserelin base)
Molecular Formula: C
59
H
84
N
18
O
14
(base)
Molecular Weight: 1269 (base)
DESCRIPTION
ZOLADEX 10.8 mg SafeSystem™ Implant contains goserelin acetate in an
amount equivalent to 10.8 mg of goserelin base.
A sterile white to cream coloured cylindrical sustained release
implant in which
goserelin acetate is dispersed in a polyglactin co-polymer
biodegradable matrix.
The implant is supplied in a single dose syringe applicator. The
SafeSystem™
incorporates a protective needle sleeve that automatically locks in
place following
administration of the implant to aid in the prevention of needle stick
injury.
ZOLADEX 10.8 mg IMPLANT Product Information
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PHARMACOLOGY
Goserelin acetate is a potent synthetic decapeptide analogue of
luteinising
hormone releasing hormone (LHRH). When given acutely, goserelin
acetate will
release luteinising hormone (LH) from the pituitary gland. However,
following
chronic administration, goserelin acetate is a potent inhibitor of
gonadotrophin
production resulting in gonadal suppression and consequently sex organ
regression.
In animals and humans, following an initial stimulation of pituitary
LH secretion and
a transient elevation in serum testosterone, chronic administration
results in
inhibition of gonadotrophin secretion. The result is a sustained
suppression of
pituitary LH occurring within approximately 3 weeks after initiation
of therapy, and
a reduction in serum testosterone levels in males to a range normally
seen in
surgically castr