国家: 以色列
语言: 英文
来源: Ministry of Health
PACLITAXEL
SALOMON,LEVIN & ELSTEIN LTD
L01CD01
CONCENTRATE FOR SOLUTION FOR INFUSION
PACLITAXEL 6 MG/ML
I.V
Required
PHARMACHEMIE BV, HOLLAND (TEVA GROUP)
PACLITAXEL
PACLITAXEL
Ovarian carcinoma : Paclitaxel Teva is indicated alone or in combination for the treatment of advanced carcinoma of the ovary. Breast carcinoma : Paclitaxel Teva is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin - containing combination chemotherapy. Paclitaxel Teva is indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Advanced non small cell lung cancer : Paclitaxel Teva associated with cisplatium 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 sarcoma : Paclitaxel Teva is indicated in the second- line treatment of AID'S related Kaposi's sarcoma. Gastric carcinoma : Paclitaxel Teva for the treatment of advanced gastric carcinoma.
2012-02-28
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _______ JANUARY 8, 2015 __ םש רישכת תילגנאב רפסמו םושירה PACLITAXEL TEVA 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION 136 41 31278 00 , 136 41 31278 01 םש לעב םושירה SALOMON, LEVIN & ELSTEIN LTD. POBOX 3696 PETACH TIKVA _ ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATION CONTRAINDICATIONS POSOLOGY, DOSAGE & ADMINISTRATION SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE ADVERSE EVENTS SKIN AND SUBCUTANEOUS TISSUE DISORDERS _Very common_: alopecia SKIN AND SUBCUTANEOUS TISSUE DISORDERS _Very common_: alopecia _Alopecia_ was observed in >80% of the patients treated with paclitaxel. The majority of alopecia events occurred less than one month after initiation of paclitaxel. Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia. PHARMACODYNAMIC PROPERTIES OVERDOSE PHARMACOKINETIC PROPERTIES PHARMACEUTICAL PARTICULARS 阅读完整的文件
93.130.565-H PACLITAXEL TEVA CONCENTRATE FOR SOLUTION FOR INFUSION FOR I.V. INFUSION SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paclitaxel Teva, 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 50ml contains 300mg of paclitaxel. Excipient with known effect: 1ml contains 527mg of the excipient, macrogolglycerol ricinoleate (castor oil polyoxyl) and 396 mg of the excipient ethanol anhydrous. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear, colourless or slightly yellow viscous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Ovarian cancer: paclitaxel is indicated alone or in combination, for the treatment of advanced carcinoma of the ovary. • Breast Cancer: - Paclitaxel is indicated 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. • Kaposi’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 section 4.5). SECOND-LINE C 阅读完整的文件