TAPROS

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

LEUPRORELIN ACETATE

제공처:

TAKEDA INDONESIA - Indonesia

INN (International Name):

LEUPRORELIN ACETATE

복용량:

1.88 MG

약제 형태:

SERBUK INJEKSI

패키지 단위:

DUS, 10 VIAL @ 1,88 MG

Manufactured by:

TAKEDA PHARMACEUTICAL COMPANY - Japan

승인 날짜:

2018-09-12

제품 특성 요약

Page 1 of 7
TAPROS

DEPOT 1.88 mg
LEUPRORELIN ACETATE
1
NAME OF THE MEDICINAL PRODUCT
TAPROS
2
COMPOSITION
Each vial contains 1.88 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
1.
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.
2.
Treatment of central precocious puberty.
4.2
Posology and Method of Administration
1.
Endometriosis
Usually,
for
adults,
3.75
mg
of
leuprorelin
acetate
is
administered
subcutaneously
or
intramuscularly once every 4 weeks for a period of 6 months only.
However, when the patient’s weight is less than 50 kg, 1.88
preparation may be used.
The treatment should start during the five first days of the menstrual
cycle.
2.
Central precocious puberty
Usually, a dose of 30 μg/kg administer subcutaneously once every 4
weeks. Depending upon the
patient’s condition, the dosage may be increased up to 90 μg/kg.
The safety of Tapros in prematures, newborns, and nursing infants has
not been established.
4.3
Contraindications
All patient populations
-
Hypersensitivity to leuprorelin, Gn-RH derivatives, to Gn-RH analogues
or to one of the components.
All females (adult and pubescent pediatric females)
-
Vaginal bleedings of non determined origin.
-
Pregnancy. Do not use when pregnancy. The non pregnancy must be
confirmed before treatment.
-
Nursing. Because of the lack of data regarding TAPROS excretion in
milk and its potential effects on
nursing mothers, TAPROS will not have to be used in this case.
DISETUJUI OLEH BPOM : 20/05/2021
ID : EREG10023512100012
Page 2 of 7
4.4
Special warnings and precautions for use
PRECAUTION
All patient populations
Since Tapros is a sustained release preparation with its action
lasting 4 weeks, administration at an
in