Retrox

Retrox Caution For Usage

bortezomib

Manufacturer:

Idaman Pharma

Distributor:

Pharmaniaga Logistics
Full Prescribing Info
Caution For Usage
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Instruction for Use as follows.
Instructions for Use: General Precautions: Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of Bortezomib. Use of gloves and other protective clothing to prevent skin contact is recommended.
Aseptic technique must be strictly observed throughout the handling of bortezomib, since it contains no preservative.
There have been fatal cases of inadvertent intrathecal administration of bortezomib. Bortezomib 1 mg powder for solution for injection is for intravenous use only, while Bortezomib 3.5 mg powder for solution for injection is for intravenous or subcutaneous use. Bortezomib should not be administered intrathecally.
Instructions for reconstitution: Bortezomib must be reconstituted by a healthcare professional.
Intravenous injection: Each 10 ml vial of bortezomib must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.
After reconstitution, each ml solution contains 1 mg bortezomib. The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Subcutaneous injection: Each 10 ml vial of bortezomib must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.
After reconstitution, each ml solution contains 2.5 mg bortezomib. The reconstituted solution is clear and colourless, 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: Bortezomib is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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