ZOLADEX DEPOT INJECTION 3.6 mgsyringe

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

GOSERELIN ACETATE EQV PEPTIDE

Beschikbaar vanaf:

ASTRAZENECA SINGAPORE PTE LTD

ATC-code:

L02AE03

Dosering:

3.6 mg/syringe

farmaceutische vorm:

INJECTION

Samenstelling:

GOSERELIN ACETATE EQV PEPTIDE 3.6 mg/syringe

Toedieningsweg:

SUBCUTANEOUS

Prescription-type:

Prescription Only

Geproduceerd door:

ASTRAZENECA UK LTD

Autorisatie-status:

ACTIVE

Autorisatie datum:

1988-05-25

Bijsluiter

ZOLADEX
®
3.6mg
goserelin
GOSERELIN 3.6MG
CONTAINS ONE DEPOT IN A PREFILLED SAFESYSTEM
® SYRINGE WITH A PROTECTIVE SLEEVE.
USE IMMEDIATELY AFTER OPENING POUCH.
USE ONLY IF POUCH IS UNDAMAGED.
Contains goserelin acetate equivalent to 3.6mg peptide base in
sustained release depot.
Also contains Lactide/Glycolide copolymer.
For subcutaneous injection.
To be administered as directed by the prescriber.
_FOR ADMINISTRATION EVERY FOUR WEEKS. _
See reverse for directions for use.
Do not store above 25°C.
Keep out of the reach of children.
This pouch contains a small white desiccant capsule which is to be
discarded after opening
the pouch.
ASTRAZENECA UK LIMITED
Macclesfield, Cheshire
United Kingdom
Made in United Kingdom
ZOLADEX SAFESYSTEM is a trademark of the AstraZeneca group of
companies.
© AstraZeneca 2021
To open tear at arrows.
ZOLADEX
® 3.6MG
goserelin
The following information is intended for medical or healthcare
professionals only:
ZOLADEX IS ADMINISTERED BY SUBCUTANEOUS INJECTION - READ AND
UNDERSTAND ALL THE INSTRUCTIONS
FULLY PRIOR TO ADMINISTRATION
1.
Put the patient in a comfortable position with the upper part of the
body slightly raised.
Prepare the injection site according to the local policy and
procedure.
NOTE: Caution should be taken while injecting Zoladex into the
anterior abdominal wall due to the
proximity of underlying inferior epigastric artery and its branches;
very thin patients may be at higher
risk of vascular injury.
2.
Examine the foil pouch and syringe for damage. Remove the syringe from
the opened foil pouch
and hold the syringe at a slight angle to the light.
Check that at least part of the Zoladex depot is visible
(FIGURE 1).
FIGURE 1.
3.
Grasp the plastic safety tab and pull away from the syringe and
discard
(FIGURE 2).
Remove
needle cover. UNLIKE LIQUID INJECTIONS, THERE IS NO NEED TO REMOVE AIR BUBBLES AS
ATTEMPTS TO DO SO
MAY DISPLACE THE ZOLADEX DEPOT.
FIGURE 2.
4.
Holding the syringe around the protective sleeve, using an aseptic
technique, pinch the patient’s
skin and i

Productkenmerken

1
ZOLADEX
® 3.6 MG_ _
(GOSERELIN)
1.
NAME OF THE MEDICINAL PRODUCT
ZOLADEX 3.6 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate (equivalent to 3.6 mg goserelin)
3.
PHARMACEUTICAL FORM
Depot, pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
i)
Prostate cancer: ZOLADEX 3.6 mg is indicated in the management of
prostate cancer
suitable for hormonal manipulation.
ii)
Breast cancer: ZOLADEX 3.6 mg is indicated in the management of breast
cancer in
premenopausal and perimenopausal women suitable for hormonal
manipulation.
iii)
Endometriosis: In the management of endometriosis, ZOLADEX 3.6 mg
alleviates
symptoms, including pain, and reduces the size and number of
endometrial lesions.
iv)
Endometrial thinning: ZOLADEX 3.6 mg is indicated for the prethinning
of the uterine
endometrium prior to endometrial ablation or resection.
v)
Uterine fibroids: In conjunction with iron therapy in the
haematological improvement of
anaemic patients with fibroids, prior to surgery.
vi)
Assisted reproduction: Pituitary downregulation in preparation for
superovulation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Caution should be taken while inserting ZOLADEX 3.6 mg into the
anterior abdominal wall
due to the proximity of underlying inferior epigastric artery and its
branches.
Use extra care when administering ZOLADEX 3.6 mg to patients with a
low body mass index
and/or who are receiving full anticoagulation medication.
For correct administration of ZOLADEX 3.6 mg, see instructions on
instruction card.
ADULTS
One 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior
abdominal wall,
every 28 days.
2
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 days.
When
downregulation
is
achieved,
superovulation
(controlled
ovarian
stimulation)
with
gonadotrophin is commenced. The downregulation achieved