国: イスラエル
言語: 英語
ソース: Ministry of Health
PACLITAXEL
NOVARTIS ISRAEL LTD
L01CD01
CONCENTRATE FOR SOLUTION FOR INFUSION
PACLITAXEL 6 MG/ML
I.V
Required
EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA
PACLITAXEL
PACLITAXEL
Paclitaxel is indicated alone or in combination, for the treatment of advanced carcinoma of the ovary. For the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically containdicated. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. Advanced non small cell lung cancer: Paclitaxel associated with cisplatinum is indicated for the treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Kaposis's sarcoma: Paclitaxel is indicated in the second-line treatment of AIDS related Kaposi's sarcoma
2014-05-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ebetaxel 6mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml contains 6mg of the active ingredient, paclitaxel 1 vial of 5ml contains 30mg of paclitaxel 1 vial of 16.7ml contains 100mg of paclitaxel 1 vial of 25ml contains 150mg of paclitaxel 1 vial of 50ml contains 300mg of paclitaxel 1 vial of 100ml contains 600mg of paclitaxel 1ml contains 522.4mg of the excipient, polyoxyl castor oil (macrogol glycerol ricinolate) For full list of excipients, see 6.1 3 PHARMACEUTICAL FORM Concentrate for solution for infusion A clear, colourless to pale yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Paclitaxel is indicated alone or in combination, for the treatment of advanced carcinoma of the ovary. • For the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically containdicated. • Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. • Advanced non small cell lung cancer: paclitaxel associated with cisplatinum is indicated for the treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. • Kaposis's sarcoma: paclitaxel is indicated in the second-line treatment of AIDS related Kaposi's sarcoma. 4.2 Dosage and Method of Administration _ _ _FIRST-LINE CHEMOTHERAPY OF OVARIAN CANCER _ Since other dosage regimens have not yet been evaluated, the recommended first- line treatment of ovarian cancer is 135 mg/m 2 of paclitaxel as an infusion over 24 hours, followed by 75 mg/m 2 of cisplatin and a therapy-free interval of three weeks (see _“Interactions with Other Medicinal Products”)._ SECOND-LINE CHEMOTHERAPY OF OVARIAN AND METASTATIC BREAST CANCER The recommended dosage is 175 mg/m 2 of paclitaxel, given as a 完全なドキュメントを読む