Instructions for Use: Handling: As with other cytotoxic agents, utmost caution should be exercised when handling paclitaxel.
Dilution of paclitaxel should take place in a designated area under aseptic conditions and be carried out by specially trained medical staff. The use of protective gloves is recommended. Contact with skin or mucous membranes must be strictly avoided. If skin contact occurs, immediate washing with water and soap is required. Upon direct contact a tingling and burning feeling and redness of the skin have been observed.
In case of contamination of the eyes, immediate rinsing with water and medical assistance are needed.
Pregnant women should be excluded from the handling of paclitaxel. Dyspnoea, thoracic pain, throat burning and nausea were reported after inhalation.
Guidelines for the handling and disposal of cytotoxic agents must be observed.
Caution should be exercised when handling paclitaxel. Contact with skin should be avoided.
The use of chemo-dispensing pins or any other pointed devices is not recommended as they may cause the stopper to collapse, sacrificing sterility of the paclitaxel solution.
Preparation of an intravenous infusion: Prior to infusion, Ebetaxel must be diluted under aseptic conditions in 0.9% sodium chloride injection or 5% glucose injection or 5% glucose and 0.9% sodium chloride solution up to a final concentration of 0.3 to 1.2 mg/ml. Chemical and physical stability of the reconstituted solution has been demonstrated for up to 48 hours (including preparation and application) at room temperature (approx. 25°C) and exposure to light. Diluted solutions should not be stored in the refrigerator.
Streaks may appear in the solution after dilution, which result from the solvent and cannot be eliminated through filtration. Infusion of Ebetaxel must take place using a filter (in-line filter) with a microporous membrane and a pore size of <0.22 µm. In a trial with a respective infusion system using an in-line filter no significant efficiency loss was detected.
In rare cases the formation of precipitates, mostly towards the end of a 24-hour infusion of Ebetaxl, was observed. These precipitates may be an indication of oversaturation of the diluted solution. Ebetexel should be used immediately after reconstitution to reduce the risk of precipitates. Excessive handling, vibrations or shaking should be avoided. Infusion sets should be carefully flushed prior to use. The solution should be closely inspected for any signs of precipitates throughout the infusion; if precipitates are observed, the infusion should be discontinued.
To minimise patient exposure to DEHP, which may be leached from PVC infusion bags, sets or other medicinal instruments, Ebetaxel preparations should only be stored in non-PVC-containing bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined infusion sets. The use of filtering devices with short PVC inlet or outlet tubing does not lead to a significant release of DEHP.
Incompatibilities: Ebetaxel as well as reconstituted paclitaxel solutions must not get in contact with containers or medical devices made of or containing PVC as the excipient macrogol glycerol ricinoleate may cause leaching of the plasticizer di-(2-ethoxyhexyl) phthalate (DEHP).
The leached amount is time- and concentration-dependent. This applies to the manufacturing and storage as well as to the administration of paclitaxel solutions. Paclitaxel should be administered by using polyethylene-lined infusion sets.
The use of filtering devices with short PVC-coated inlet or outlet tubing has not resulted in significant leaching of DEHP.