Trade name
Myozyme
Presentation and preparation
|
Vial size
(powder volume) |
Fluid to add
|
Volume to add
|
Resulting concentration
|
|---|---|---|---|
| 50 mg (0.2 mL) |
Water for injections | 10.3 mL | 5 mg/mL |
Vials contain a significant amount of overage; Myozyme 50 mg vials contain 52.5 mg alglucosidase alfa and 0.2 mL powder volume.
Allow vials to reach room temperature prior to reconstitution. Reconstitute with 10.3 mL to provide a 5 mg/mL solution. Slowly add water for injections down the vial wall to avoid foaming. Tilt and roll gently, do not invert, swirl or shake.
IV administration
Slowly withdraw the dose to avoid foaming, then dilute to 0.5 – 4 mg/mL with sodium chloride 0.9%. Remove airspace from the infusion bag first, then add drug directly into fluid. Gently mix, do not shake.
Infuse via a 0.2 micron low protein binding in-line filter over approximately 4 hours.
Initial rate: 1 mg/kg/hour.
If tolerated, may increase rate by 2 mg/kg/hour every 30 minutes to a maximum rate of 7 mg/kg/hour.
Other routes of administration
IM: Not recommended
SC: Not recommended
Compatible IV fluids
Sodium chloride 0.9%
Additional information
Observe closely for anaphylactic reactions during and for 3 hours after administration.
Use only when facilities for cardiac monitoring and cardio-respiratory resuscitation exist.
Monitor vital signs before each rate increase.
For mild to moderate infusion reactions, decrease the rate or temporarily withhold the infusion.
Reconstituted solution should be clear and colourless or slightly yellow, and may contain thin translucent fibres. Do not use if solution is discoloured or contains opaque particles.
Protect reconstituted and diluted solutions from light. During administration cover solution with a light-excluding pouch.
Refrigerate, do not freeze.