TAPROS 3M DEPOT

国家: 印度尼西亚

语言: 印度尼西亚文

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

有效成分:

LEUPRORELIN ACETATE

可用日期:

TAKEDA INDONESIA - Indonesia

INN（国际名称）:

LEUPRORELIN ACETATE

剂量:

11,25/VIAL

药物剂型:

SERBUK INJEKSI

每包单位数:

DUS, 1 VIAL @ 11,25 MG + 1

厂商:

TAKEDA PHARMACEUTICAL COMPANY - Japan

授权日期:

2017-12-07

产品特点

Page 1 of
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TAPROS

3 M DEPOT
LEUPRORELIN ACETATE
1
NAME OF THE MEDICINAL PRODUCT
TAPROS

3 M DEPOT
2
COMPOSITION
Each vial contains 11.25 mg Leuprorelin Acetate
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White powder and clear, colorless solvent for suspension for
injection.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
-
Treatment of prostatic cancer with metastase.
-
Treatment of endometriosis at genital and extragenital localization
(from stage I to stage IV).
The clinical knowledge concerning the endometriosis treatment is
limited to women over 18
years old.
The treatment duration is limited to 6 months.
It is not recommended to start a second treatment period with TAPROS
or with another Gn-RH
analogue.
-
Breast cancer in pre-menopausal and peri-menopausal women, provided
endocrine treatment is
indicated.
-
Treatment of central precocious puberty.
4.2
Posology and method of administration
-
Prostatic cancer and breast cancer
One subcutaneous or intramuscular injection which will be renewed
every 3 months.
-
Endometriosis
The treatment should start during the five first days of the menstrual
cycle.
One subcutaneous or intramuscular injection will be renewed every 3
months.
Duration: endometriosis will be treated during no more than 6 months
whatever is the stage.
-
Central Precocious Puberty
The treatment of children with leuprorelin acetate should be under the
overall supervision of
the paediatric endocrinologist.
The dosing scheme needs to be adapted individually.
The recommended starting dose is dependent on the body weight.
Children with a body weight ≥ 20 kg
2 ml (11.25 mg leuprorelin acetate) suspension of 1 vial injection
powder in 2 ml vehicle solution
(1 ampoule) are administered every 3 months as a single subcutaneous
injection.
Children with a body weight < 20 kg
Tapros 3M Depot is not recommended for use in children with a
bodyweight under 20 kg.
In these rare cases Tapros 1.88mg 1M depot is available for use in
these patients.
DISETUJUI OLEH BPOM : 20/05/2021
ID : EREG100