TAPROS 3M DEPOT

Country: ইন্দোনেশিয়া

ভাষা: ইন্দোনেশীয়

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

সক্রিয় উপাদান:

LEUPRORELIN ACETATE

থেকে পাওয়া:

TAKEDA INDONESIA - Indonesia

INN (International Name):

LEUPRORELIN ACETATE

ডোজ:

11,25/VIAL

ফার্মাসিউটিকাল ফর্ম:

SERBUK INJEKSI

প্যাকেজ ইউনিট:

DUS, 10 VIAL @ 11,25 MG (BULK)

Manufactured by:

TAKEDA PHARMACEUTICAL COMPANY - Japan

অনুমোদন তারিখ:

2017-12-07

পণ্য বৈশিষ্ট্য

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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