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This medicinal product has only been shown to be compatible with sodium chloride 9 mg/mL (0.9% w/v) solution for injection. Accordingly, only this diluent should be used for reconstitution. Compatibility with other active substances has not been studied. Therefore, it is not recommended to mix this medicinal product with other active substances when reconstituted.
Reconstitution at concentrations greater than 38 mg/mL may result in incomplete dissolution, and should be avoided.
To reconstitute, slowly add the appropriate volume of sodium chloride 9 mg/mL (0.9% w/v) solution for injection (as stated in the table as follows) and shake to dissolve. (See Table 8.)
Click on icon to see table/diagram/imageThe appropriate amount of medicinal product may be further diluted with sodium chloride 9 mg/mL (0.9% w/v) solution for injection.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration, prior to administration, whenever solution and container permit.
Any unused solution should be discarded as described as follows.
Guidelines for the Safe Handling of Cytotoxic Medicinal Products: Local guidelines on safe preparation and handling of cytotoxic medicinal products must be adhered to. Cytotoxic preparations should not be handled by pregnant staff. The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used. This should be performed in a designated area. The work surface should be covered with disposable plastic-backed absorbent paper.
Suitable eye protection, disposable gloves, face mask and disposable apron should be worn. Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. If accidental contamination occurs, the eye should be washed with water thoroughly and immediately.
Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended). Large bore needles are recommended to minimise pressure and the possible formation of aerosoles. The latter may also be reduced by the use of a venting needle.
Actual spillage or leakage should be mopped up wearing protective gloves. Excreta and vomit must be handled with care.
Disposal: Adequate care and precaution should be taken in the disposal of items used to reconstitute this medicinal product. Any unused dry 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. Waste material should be destroyed by unused incineration. Any product or waste material should be disposed of in accordance with local requirements.
