Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Paclitaxel
Fresenius Kabi Limited
L01CD; L01CD01
Paclitaxel
6 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Taxanes; paclitaxel
Marketed
2009-04-03
PACLITAXEL - PACKAGE INSERT - IRELAND+UK (BORDON) (Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\Travesh\Paclitaxel (Bordan)\Ireland-UK\16 Sep 2016\Paclitaxel - Package Insert - Ireland+UK (Bordon).indd SIZE: 592 X 300 MM LFT00285 7220132501 V003/BO 18 JANUARY 2017 1:27 PM VER. 01 TIMES NEW ROMAN 10 PTS. Black THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: HANDLING : As with all antineoplastic agents, caution should be exercised when handling paclitaxel. Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Adequate protective gloves should be worn. Precautions should be taken to avoid contact with the skin and mucous membranes. In the event of contact with the skin, the area should be washed with soap and water. Following topical exposure, tingling, burning and redness have been observed. In the event of contact with the mucous membranes, these should be flushed thoroughly with water. Upon inhalation, dyspnoea, chest pain, burning throat and nausea have been reported. If unopened vials are refrigerated, a precipitate may form that redissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Following multiple needle entries and product withdrawals, the vials maintain microbial, chemical and physical stability for up to 28 days at 25°C. Other in-use storage times and conditions are the responsibility of the user. The Chemo-Dispensing Pin device or similar devices with spikes should not be used since they can cause the vial stopper to collapse, resulting in loss of sterile integrity. PREPARATION FOR IV ADMINISTRATION: Prior to infusion, paclitaxel must be diluted using aseptic techniques in 5% Glucose solution, 0.9% Sodium Chloride solution, 5% Glucose solution in Ringer solution, and 5% Glucose solution/0.9% Sodium Chloride solution to a final concentration of 0.3 to 1.2 mg/ml. Chemical and physical in Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paclitaxel 6 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 6 mg of paclitaxel. One 5 ml vial contains 30 mg paclitaxel. One 16.7 ml vial contains 100 mg paclitaxel. One 25 ml vial contains 150 mg paclitaxel. One 50 ml vial contains 300 mg paclitaxel. One 100 ml vial contains 600 mg paclitaxel. Excipients with known effect: Ethanol, anhydrous 393 mg/ml (49.7 % (v/v) Macrogolglycerol ricinoleate, 530 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, slightly yellowish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OVARIAN CARCINOMA: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease ( > 1 cm) after initial laparotomy, in combination with cisplatin. In the second-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of standard, platinum containing therapy. BREAST CARCINOMA: In the adjuvant setting, paclitaxel is indicated for the treatment of patients with node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy. Adjuvant treatment with paclitaxel should be regarded as an alternative to extended AC therapy. Paclitaxel is indicated for the initial treatment of locally advanced or metastatic breast cancer either in combination with an anthracycline in patients for whom anthracycline therapy is suitable, or in combination with trastuzumab, in patients who over-express HER-2 (human epidermal growth factor receptor 2) at a 3+ level as determined by immunohistochemistry and for whom an anthracycline is not suitable (see section 4.4 and 5.1). As a single agent, paclitaxel is indicated for the treatment of metastatic carcinoma of the breast in patients wh Soma hati kamili