Trade name
Entyvio
Presentation and preparation
|
Vial size
(powder volume) |
Fluid to add
|
Volume to add
|
Resulting concentration
|
|---|---|---|---|
| 300 mg (0.2 mL) |
Water for injections | 4.8 mL | 60 mg/mL |
Slowly add 4.8 mL water for injections down the wall of the vial to avoid foaming. Gently swirl for at least 15 seconds. Do not shake or invert. Stand the vial for up to 20 minutes to allow any foam to settle, the vial can be swirled and inspected for dissolution during this time. If not fully dissolved, allow to stand for another 10 minutes for dissolution. Do not use the vial if the drug product is not dissolved within 30 minutes.
Prefilled pen or syringe
108 mg/0.68 mL
IV administration
Vial only
Gently invert the reconstituted vial 3 times prior to dilution.
Dilute to 1.2 mg/mL with a compatible fluid and give over 30 minutes. Gently invert bag to mix. Do not shake.
Other routes of administration
IM: Not recommended.
SC: Suitable. Prefilled pen or syringe only. Remove from refrigerator, allow to come to room temperature for 30 minutes before injecting.
Compatible IV fluids
Prepared solutions should be used immediately
Sodium chloride 0.9%
Hartmann’s (8 hours if refrigerated)
Additional information
Observe closely for anaphylactic reactions.
Use only when facilities for cardiac monitoring and cardio-respiratory resuscitation exist.
Monitor patient for infusion reactions and reduce rate of administration if not tolerated.
Reconstituted vial is stable for 8 hours if refrigerated.
Reconstituted solution should be clear or opalescent, colourless to light yellow. Prefilled pen or syringe solution should be colourless to yellow.
Discard any unused vial, syringe, or pen contents.
Refrigerate, do not freeze.
Protect from light during storage.