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Special precautions for disposal and other handling: Vials are for single use only.
Reconstitution: Aseptic technique should be used during reconstitution.
1. The number of vials have to be determined to be reconstituted based on individual patient's weight and the recommended dose of 20 mg/kg or 40 mg/kg.
Patient weight (kg) x dose (mg/kg) = patient dose (in mg). Patient dose (in mg) divided by 100 mg/vial = number of vials to reconstitute. If the number of vials includes a fraction, it should be rounded up to the next whole number.
Example: Patient weight (16 kg) x dose (20 mg/kg) = patient dose (320 mg). 320 mg divided by 100 mg/vial = 3.2 vials; therefore, 4 vials should be reconstituted.
Example: Patient weight (16 kg) x dose (40 mg/kg) = patient dose (640 mg).
640 mg divided by 100 mg/vial = 6.4 vials; therefore, 7 vials should be reconstituted.
2. The required number of vials needed for the infusion should be removed from the refrigerator and set aside for approximately 30 minutes to allow them to reach room temperature.
3. Each vial should be reconstituted by slowly injecting 10.0 ml of water for injections (WFI) to each vial. Each vial will yield 100 mg/10 ml (10 mg/ml). Forceful impact of the WFI on the powder and foaming should be avoided. This is performed by slow drop-wise addition of the WFI down the inside of the vial and not directly onto the lyophilised powder. Each vial should be tilted and rolled gently to dissolve the lyophilised powder. It should not be inverted, swirled, or shaken.
4. Immediate visual inspection should be performed on the reconstituted vials for particulate matter and discoloration. If upon immediate inspection particles are observed or if the solution is discoloured, the reconstituted medicinal product should not be used. The solution should be allowed to become dissolved.
Dilution: 5. The reconstituted solution should be diluted in 5% glucose in water to a final concentration of 0.5 mg/ml to 4 mg/ml. See Table 6 for the recommended total infusion volume based on the patient weight.
6. The volume of reconstituted solution from each vial should be slowly withdrawn (calculated according to patient's weight).
7. The reconstituted solution should be added slowly and directly into the 5% glucose solution. Foaming or agitation of the infusion bag should be avoided. Air introduction into the infusion bag should be avoided.
8. To mix the infusion bag solution, gently invert or massage the infusion bag to mix. It should not be shaken.
9. To avoid administration of inadvertently introduced particles during dose IV preparation, it is recommended to use an in-line, low protein binding, 0.2 μm filter to administer Nexviazyme. After the infusion is complete, the intravenous line should be flushed with glucose 5% in water.
10. Nexviazyme should not be infused in the same intravenous line with other medicinal products. (See Table 6.)
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