TAPRos DEPOT 1.88 mg LEUPRORELIN ACETAT

Transcription

1 (" I I TAPRos DEPOT 1.88 mg LEUPRORELIN ACETAT 1 NAME OF THE MEDICINAL PRODUCT TAP ROS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Powder: Leuprorelin Copolymer (DL-Lactic acid/glycolic acid) 75/25 mol% Mannitol For one vial 1.88 mg mg 3.30 mg Solvent: Sodium carboxymethylcellulose Mannitol Polysorbate 80 Water for injection... sufficient quantity for For one ampoule mg mg 2.00 mg 2 ml 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 Ta pros in prematures, newborns, and nursing infants has not been established. I Pl_Taprosl.88 veroi_jul 14 1 of7

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8 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% mg Mannitoi 6.60 mg For one vial Solvent: Sodium carboxymethylcellulose mg Mannitol mg Polysorbate 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

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18 TAPROS 3M DEPOT LEUPRORELIN ACETATE 1 NAME OF THE MEDICINAL PRODUCT TAPROS 3M DEPOT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Powder: Leuprorelin acetate Polylactic acid Mannitol mg mg mg ) For one vial Solvent: Sodium carboxymethyl cellulose Mannitol Polysorbate 80 Water for injection sufficient quantity for For one ampoule mg mg 2.00 mg 2 ml 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

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