ZOLADEX

מדינה: אינדונזיה

שפה: אינדונזית

מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

מרכיב פעיל:

GOSERELIN ACETATE

זמין מ:

ASTRAZENECA INDONESIA - Indonesia

INN (שם בינלאומי):

GOSERELIN ACETATE

כמות:

3,6 MG/DEPOT

טופס פרצבטיות:

CAIRAN INJEKSI

יחידות באריזה:

DUS, 1 SYRINGE @ 3,6 MG

תוצרת:

ASTRAZENECA UK LIMITED

תאריך אישור:

2017-10-07

מאפייני מוצר

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Page 1 of 9
ZOLADEX
®
_ _
_goserelin _
IMPLANT/DEPOT 3.6 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate (equivalent to 3.6 mg goserelin)
PHARMACEUTICAL FORM
ZOLADEX is presented as a sterile, white to cream coloured cylindrical
depot in which
goserelin acetate (equivalent to 3.6 mg of goserelin) is dispersed in
a biodegradable matrix
of lactide-glycolide copolymer. It is supplied as a single dose
SafeSystem
™
syringe
applicator with a protective sleeve in a sealed pouch which contains a
desiccant.
THERAPEUTIC INDICATIONS
i)
Prostate cancer: ZOLADEX is indicated in the management of prostate
cancer suitable
for hormonal manipulation.
ii)
Breast cancer: ZOLADEX 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
alleviates symptoms,
including pain, and reduces the size and number of endometrial
lesions.
iv) Endometrial thinning : ZOLADEX is indicated for the prethinning of
the uterine
endometrium prior to endometrial ablation or resection and endometrial
biopsy prior to
using Zoladex is not showing malignancy or atypical endometrial
hyperplasia or pelvic
inflammatory disease.
v) Assited reproduction : Pituitary downregulation in preparation for
superovulation.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Caution should be taken while inserting ZOLADEX into anterior
abdominal wall due to the
proximity of underlying inferior epigastric artery and its branches
Use extra care when administering ZOLADEX to patients with a low body
mass index (BMI)
and/or who are receiving full anticoagulation medication (_see special
warning and special _
_precautions for use_)
For correct administration of ZOLADEX, see instructions on the
instruction card.
One 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior
abdominal wall
every 28 days.
DISETUJUI BPOM: 15/10/2019
ID: EREG10042211900037
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Assisted reproduction: ZOLADEX is administered to downre