Instructions for Use: Dilution: Anzatax Injection Concentrate MUST BE DILUTED PRIOR TO INTRAVENOUS INFUSION. It should be diluted in 5% glucose or 0.9% sodium chloride intravenous infusion.
Dilution should be made to a final concentration of 0.3 to 1.2 mg/mL.
After the final dilution of Anzatax Injection Concentrate, the bottle should be swirled gently to disperse the paclitaxel. DO NOT SHAKE.
Avoid contact of paclitaxel solutions with plasticised polyvinyl chloride (PVC) equipment, infusion lines or devices used when preparing infusion solutions. Prepare and store diluted paclitaxel solutions in glass bottles or non-PVC infusion bags. These precautions are to avoid leaching of the plasticiser DEHP (di-[2-ethylhexyl] phthalate) from PVC infusion bags or sets.
Paclitaxel solutions should be administered through polyethylene lined administration sets (e.g. Gemini 20 giving set), using an IMED pump.
Although solutions of paclitaxel for infusion prepared as outlined previously are chemically stable for 3 days at room temperature (25°C) and 14 days at 2°C to 8°C, it is recommended that the solution for infusion should be administered immediately after preparation as it does not contain an antimicrobial agent. The infusion should be completed within 24 hours of preparation of the solution and any residue discarded, according to the guidelines for the disposal of cytotoxic drugs (see Handling and Disposal as follows). Use in one patient on one occasion only.
Compounding centres which have validated aseptic procedure and regular monitoring of aseptic technique may apply the following shelf lives when stored under the specified conditions: (see table.)
Click on icon to see table/diagram/image
Solutions prepared this way have been shown to be chemically stable for these periods.
Administration should be completed within 24 hours of the start of the infusion and any residue discarded according to the guidelines for the disposal of cytotoxic drugs. Do not use paclitaxel if any precipitation forms or if the diluted solution appears cloudy.
Incompatibilities: PEG 35 Castor Oil can result in di-(2-ethylhexyl) phthalate [DEHP] leaching from plasticized polyvinyl chloride (PVC) containers, at levels which increase with time and concentration.
Consequently, the preparation, storage, and administration of paclitaxel should be carried out in non-PVC containing equipment such as glass, polypropylene, or polyolefin.
Special precautions for disposal: Handling and Disposal: The published guidelines related to procedures for the proper handling and disposal of cytotoxic drugs should be followed.
Care must be taken whenever handling cytostatic products. Always take steps to prevent exposure. This included appropriate equipment, such as wearing gloves and washing hands with soap and water after handling such products.
Paclitaxel is a cytotoxic anticancer drug and as with other potentially toxic compounds, caution should be exercised in handling paclitaxel. The use of gloves is recommended. Following topical exposure, tingling, burning, redness have been observed. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnoea, chest pain, burning eyes, sore throat and nausea have been reported. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.