ZOLADEX LA CAIRAN INJEKSI 10,8 MG/DEPOT

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

GOSERELIN ACETATE

Tilgængelig fra:

ASTRAZENECA INDONESIA - Indonesia

INN (International Name):

GOSERELIN ACETATE

Dosering:

10,8 MG/DEPOT

Lægemiddelform:

CAIRAN INJEKSI

Enheder i pakken:

DUS, 1 SYRINGE @ 10,8 MG

Fremstillet af:

ASTRAZENECA UK LIMITED

Autorisation dato:

2015-06-04

Produktets egenskaber

Page 1 of
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ZOLADEX
®
LA
_goserelin_
IMPLANT/DEPOT 10.8 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate (equivalent to 10.8 mg goserelin)
PHARMACEUTICAL FORM
ZOLADEX LA is presented as a sterile, white to cream coloured
cylindrical depot in which
goserelin acetate (equivalent to 10.8 mg of goserelin) is dispersed in
a biodegradable matrix of
lactide-glycolide co-polymer. It is supplied as a single dose
SafeSystem™ syringe applicator
with a protective sleeve in a sealed pouch which contains a desiccant.
THERAPEUTIC INDICATIONS
PROSTATE CANCER : ZOLADEX LA is indicated in the management of
prostate cancer suitable
for hormonal manipulation.
PREMENOPAUSAL BREAST CANCER : ZOLADEX LA is indicated in the
management of
premenopausal breast cancer for hormone receptor positive.
ENDOMETRIOSIS : ZOLADEX LA is indicated in the management of
endometriosis including
alleviation of symptoms such as pain. Experience with Zoladex LA for
the management of
endometriosis has been limited to women 18 years of age and older
treated for 6 months.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULT MALES (INCLUDING THE ELDERLY)
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 10.8 mg depot of ZOLADEX LA injected subcutaneously into the
anterior abdominal wall,
every 12 weeks.
No dosage adjustment is necessary for patients with renal impairment.
No dosage adjustment is necessary for patients with hepatic
impairment.
FEMALES
One 10.8 mg depot of ZOLADEX LA injected subcutaneously into the
anterior abdominal wall,
every 12 weeks.
DISETUJUI BPOM : 16/03/2020
ID : EREG10042211900038
Page 2 of
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CHILDREN
ZOLADEX LA is not indicated for use in ch