国: インドネシア
言語: インドネシア語
ソース: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 7 BLISTER@ 4 KAPSUL
2022-06-04
TAXOL® PACLITAXEL INJECTION TAXOL ® 6 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION 1. NAME OF THE MEDICINAL PRODUCT Taxol ® 6 mg/ml, concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Paclitaxel: 6 mg per 1 ml of concentrate for solution for infusion. A vial of 5 ml contains 30 mg of paclitaxel. A vial of 16.7 ml contains 100 mg of paclitaxel. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Taxol ® is a clear, colourless to slightly yellow viscous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TAXOL is indicated for the treatment of the following: OVARIAN CARCINOMA · First-line therapy in combination with a platinum compound for the treatment of advanced metastatic carcinoma of the ovary. · Second-line therapy for the treatment of advanced metastatic carcinoma of ovary. BREAST CARCINOMA · Adjuvant treatment of node-positive breast cancer administered sequentially to standard combination therapy. · Therapy after relaps within 6 months of adjuvant therapy. Prior therapy should have included an anthracycline unless clinically contraindicated. · Second-line therapy after failure of combination chemotherapy for metastatic disease. Prior therapy should have included an anthracycline unless clinically contraindicated. · For the treatment of advanced or metastatic breast cancer in combination with trastuzumab in patients who over express HER-2 at 3+ level as determined by immunohistochemistry or FISH + NON-SMALL CELL LUNG CARCINOMA · First-line therapy in combination with a platinum compound for the treatment of non- small cell carcinoma of the lung in patients who are not candidates for potentially curative surgery and/or radiation therapy. KAPOSI’S SARCOMA · Second-line treatment of AIDS-related Kaposi’s Sarcoma 4.2 POSOLOGY AND METHOD OF ADMINISTRATION All patients must be premedicated with corticosteroids, antihistamines, and H2 antagonists prior to Taxol, e.g. DRUG DOSE ADMINISTRATION PRIOR TO 完全なドキュメントを読む