Sindaxel Caution For Usage

Paclitaxel contains: Alcohol (ethanol) approximately 50% by volume, that is up to about 20 g per dose. This is equivalent to half a litre of beer per dose or a large glass (210ml) of wine per dose. This amount may be dangerous for patients suffering from alcoholism and for high risk patients including those with liver problems or epilepsy (fits). The amount of alcohol in this product may alter the effects of other medicines.
Macrogolglycerol ricinoleate, which can cause severe allergic (hypersensitivity) reactions.
Instructions for use: Cytostatic Agent: Handling of Paclitaxel: As with all cytostatic agents, caution should be exercised when handling Paclitaxel. Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Precautions should be taken to avoid contact with the skin and mucous membranes. Following topical exposure, tingling, burning and erythema have been observed. Upon inhalation, dyspnoea, chest pain, burning throat and nausea have been reported.
Protection instructions for preparation of Paclitaxel solution for infusion: 1. Protective chamber should be used and protective gloves as well as protective gown should be worn. If there is no protective chamber available mouth cover and goggles should be used.
2. Opened containers, like injection vials and infusion bottles and used canules, syringes, catheters, tubes, and residuals of cytostatics should be considered as hazardous waste and undergo disposal according to local guidelines for the handling of hazardous waste.
3. Follow the instructions below in case of spillage: protective clothing should be worn; broken glass should be collected and placed in the container for hazardous waste; contaminated surfaces should be flushed properly with copious amounts of cold water; the flushed surfaces should then be wiped thoroughly and the materials used for wiping should be disposed as hazardous waste.
4. In the event of Paclitaxel contact with the skin, the area should be rinsed with plenty of running water and then washed with soap and water. In case of contact with mucous membranes, wash the contacted area thoroughly with water. If the patient has any discomfort, contact a doctor.
5. In case of contact of Paclitaxel with eyes, wash them thouroughly with plenty of cold water. Contact an ophthalmologist immediately.
Preparation of infusion solution: So called "closed system", e.g. the Chemo-Dispensing Pin device or similar devices, should not be used for withdrawal of the doses from injection vial since they can cause the vial stopper to collapse, resulting in loss of sterile integrity.
Preparation, storage and administration should be carried out in non-PVC containing equipment (see section "Incompatibilities" as follows).
Prior to infusion, Paclitaxel 6mg/ml concentrate for solution for infusion must be diluted, using aseptic techniques. The following solutions for infusion can be used for dilution: 0.9% Sodium Chloride solution for infusion, or 5% Glucose solution for infusion, or 5% Glucose and 0.9% Sodium Chloride solution for infusion, or 5% Glucose in Ringer's solution for infusion, to a final concentration of 0.3 to 1.2mg/ml.
There have been rare reports of precipitation during paclitaxel infusions, usually towards the end of a 24 hour infusion period.
Although the cause of this precipitation has not been elucidated, it is probably linked to the supersaturation of the diluted solution. To reduce the precipitation risk, paclitaxel should be used as soon as possible after dilution and excessive agitation, vibration or shaking should be avoided.
Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle, and is not removed by filtration. In order to reduce the precipitation risk the diluted Paclitaxel infusion should be used as soon as possible after dilution.
Infusion technique: Paclitaxel infusion solution should be administered as intravenous infusion. Paclitaxel should be administered through an in-line filter with a microporous membrane ≤ 0.22 μm. (No significant losses in potency have been noted following simulated delivery of the solution through IV tubing containing an in-line filter.)
The infusion sets should be flushed thoroughly before use. During infusion, the appearance of the solution should be regurlarly inspected and the infusion should be stopped if precipitation is present.