Special precautions for disposal and other handling: Inspection prior to use: As with all parenteral drug products, Docetaxel Sandoz concentrate for solution for infusion should be inspected visually for particulate matter and discolouration prior to use, whenever solution and container permit, solutions containing a precipitate should be discarded.
Preparation of the infusion solution: Must be diluted before use.
Infusion solutions have to be prepared with either 0.9% sodium chloride or with 5% glucose and administered as an intravenous infusion. The infusion solution may be prepared at most 4 hours before use.
The required volume can be directly withdrawn from the vial.
More than one vial may be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume containing 10 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel concentrate for solution for infusion.
Inject the required volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
If a dose greater than 200mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded. Mix the infusion bag or bottle manually using a rocking motion.
The Docetaxel infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting condition. From a microbiological point of view, the product should be used immediately.
Contact of the Docetaxel Sandoz concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer (DEHP) (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the final Docetaxel Sandoz dilution for infusion should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
pH and osmolality of reconstituted solution: 0.3 mg/mL in Glucose 5%: pH ≈ 3.6; 517 mOsm/kg.
0.74 mg/mL in NaCl 0.9%; pH ≈ 3.3 - 3.6; 849 mOsm/kg.
Guidelines for the Safe Handling of Antineoplastic Agents: Cytotoxic preparations should not be handled by pregnant staff. Trained personnel should dilute the drug. This should be performed in a designated area. The work surface should be covered with disposable plastic-backed absorbent paper.
Adequate protective gloves, masks, and clothing should be worn. Precautions should be taken to avoid the drug accidentally coming into contact with skin or mucous membranes; the affected area should be cleaned thoroughly with soap and water. if accidental contamination occurs with the eyes, they should be washed with water thoroughly and immediately.
Use Luer-lock fittings on all syringes and sets. Large bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.
Any unused contents should be discarded. Adequate care and precaution should be taken in the disposal of items used to dilute Docetaxel Sandoz. Any unused product or contaminated materials should be placed in a high-risk waste bag. Sharp objects (needles, syringes, vials, etc) should be placed in a suitable rigid container. Personnel concerned with the collection and disposal of this waste should be aware of the hazard involved. Any unused product or waste material should be disposed of in accordance with standard procedures applicable to cytotoxic agents. Any excess drug solution should be flushed directly into a drain with copious amounts of water.
This medicinal product is for single use only.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except for those mentioned in Description.