देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: 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 पूरा दस्तावेज़ पढ़ें