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Incompatibilities: This product must not be mixed with other medicinal products except those mentioned in Method of Administration under Dosage & Administration.
Special precautions for disposal and other handling: General precautions: Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of MYBORTE 1.0MG. Use of gloves and other protective clothing to prevent skin contact is recommended.
Aseptic technique must be strictly observed throughout the handling of MYBORTE 1.0MG, since it contains no preservative.
There have been fatal cases of inadvertent intrathecal administration of BORTEZOMIB. MYBORTE 1.0MG is for intravenous use. MYBORTE 1.0MG should not be administered intrathecally.
MYBORTE 1.0MG is available for intravenous administration.
Instructions for reconstitution: MYBORTE 1.0MG must be reconstituted by a healthcare professional.
Intravenous injection: Each 5 ml vial of bortezomib must be reconstituted with 1 ml of sodium chloride 0.9% solution for injection. Dissolution of the lyophilized powder is completed in less than 2 minutes.
After reconstitution, each ml solution contains 1 mg bortezomib. The reconstituted solution is clear and colorless, with a final pH of 4 to 7.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Disposal: MYBORTE 1.0MG is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
