TAPROS

País: Indonesia

Idioma: indonesio

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

Disponible desde:

TAKEDA INDONESIA - Indonesia

Dosis:

3,75 MG/VIAL

formulario farmacéutico:

SERBUK INJEKSI

Unidades en paquete:

DUS, 200 AMPUL @ 2 ML (BULK)

Fabricado por:

TAKEDA PHARMACEUTICAL COMPANY - Japan

Fecha de autorización:

2018-09-12

Ficha técnica

Page 1 of 11
TAPROS

DEPOT 3.75 mg
LEUPRORELIN ACETATE
1
NAME OF THE MEDICINAL PRODUCT
TAPROS

DEPOT 3.75 mg
2
COMPOSITION
Each vial contains 3.75 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.
-
Pre-operative management of uterine myoma (fibroid) to reduce their
size and associated
bleeding.
-
Treatment of central precocious puberty.
-
Breast cancer in pre-menopausal and peri-menopausal women, provided
endocrine treatment is
indicated.
It is not recommended to start a second treatment period with Tapros
or with another Gn-RH
analogue.
4.2
Posology and method of administration
-
Prostatic cancer and breast cancer
One subcutaneous injection which will be renewed every four weeks.
-
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.
-
Uterine myoma (fibroid)
One subcutaneous or intramuscular injection will be renewed every 4
weeks.
The treatment should start during the five first days of the menstrual
cycle.
-
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 Gn-RH, to Gn-RH analogues or to one of the