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TAPRos ® DEPOT 1.88 mg

LEUPRORELIN ACETAT

1 NAME OF THE MEDICINAL PRODUCT

TAP ROS®

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Powder:
Leuprorelin 1.88 mg
Copolymer (DL-Lactic acid/glycolic acid) 75/25 mol% 16.88 mg
Mannitol 3.30 mg
For one vial

Solvent:
Sodium carboxymethylcellulose 10.00 mg
Mannitol 100.00 mg
Polysorbate 80 2.00 mg
Water for injection ............ sufficient quantity for 2 ml
For one ampoule

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.

I Pl_Taprosl.88 verOI_Jul 14 1 of7

 L

TAPROS ® DEPOT 3.75 mg

LEUPRORELIN ACETATE

1 Nil.ME OF THE MED!CINAL PRODUCT

TAP ROS,;;, DEPOT 3.75 m5

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Powder:
Leuprorelin 3.75 mg
Copolymer (DL-Lactic acid/glycolic acid)75/25 mol% 33.75 mg
Mannitoi 6.60 mg
For one vial
Solvent:
Sodium carboxymethylcellulose 10.00 mg
Mannitol 100.00 mg
,'
Polysorbate 80 2.00 mg
Water for injection......sufficient quantity for 2 ml
For one ampoule

3 PHARMACEUTICAL FORM
White powder and clear, colorless solvent for suspension for injection.

4 CLINICAL PARTICLJLARS

4.1 Therap2u�ic indications

- Treatment of r,rostatic cancer with metas�ase.
- 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 Poso!ogy 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 subcutaneous!y or
intramuscularly once every 4 weeks for a period of 6 months only.
However. when the pa�ient's ,:.eight is less than 50 kg, 1.88 preparation may be used.

The treatment should start during the five first days of the menstrual cycle.

PI_Tapros3.75 \,:r1ll_Jull..t
 TAPROS® 3M DEPOT
LEUPRORELIN ACETATE

1 NAME OF THE MEDICINAL PRODUCT

®
TAPROS 3M DEPOT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Powder:
Leuprorelin acetate 11.25 mg
Polylactic acid 99.30 mg
Mannitol 19.45 mg

For one vial

)
Solvent:
Sodium carboxymethyl cellulose 10.00 mg
Mannitol 100.00 mg
Polysorbate 80 2.00 mg
Water for injection sufficient quantity for 2 ml
For one ampoule

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.

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.

PI_Taprosl 1.25 verOI_Jull4 1