C1 Esterase Inhibitor, Human
Trade name
Berinert IV, Berinert SC, Cinryze
Presentation and preparation
For IV administration:
|
Vial size
(powder volume) |
Fluid to add
|
Volume to add
|
Resulting concentration
|
|---|---|---|---|
|
Berinert IV: |
Water for injections provided using Mix2Vial filtering system |
10 mL |
50 units/mL |
|
Berinert IV: |
Water for injections provided using Mix2Vial filtering system |
3 mL |
500 units/mL |
|
Cinryze: |
Water for injections provided using transfer device provided |
5 mL |
100 units/mL |
Reconstitute as above. Swirl gently to dissolve. Do not shake.
For SC administration:
|
Vial size
(powder volume) |
Fluid to add
|
Volume to add
|
Resulting concentration
|
|---|---|---|---|
|
Berinert SC: |
Water for injections provided using Mix2Vial filtering system |
4 mL |
500 units/mL |
|
Berinert SC: |
Water for injections provided using Mix2Vial filtering system |
5.6 mL |
500 units/mL |
Reconstitute as above. Swirl gently to dissolve. Do not shake. May take up to 10 minutes to dissolve.
IV administration
Refer to the package insert and local guidelines for detailed instructions. Allow product to reach room temperature before administration.
Berinert IV 500 units vial:
Give undiluted at a maximum rate of 4 mL/minute (200 units/minute).
Berinert IV 1500 units vial:
Give undiluted as a slow injection over at least 3 minutes.
Cinryze:
Give undiluted at a rate of 1 mL/minute (100 units/minute).
May be given as an infusion.
Other routes of administration
IM: Not recommended.
SC: Suitable.
Berinert SC only: Inject into the abdomen.
Additional information
Observe closely for anaphylactic reactions.
If multiple vials of C1 esterase inhibitor are required, a separate Mix2Vial set must be used for each vial.
Use the syringe provided or a silicone-free syringe.
Protect from light during storage.
Discard any unused vial contents.
Derived from human plasma – document brand name and batch number for each dose administered according to local guidelines.
Berinert IV 500 units vial:
Reconstituted solution should be clear and colourless.
Reconstituted solution is stable for 24 hours when refrigerated in the vial.
Berinert IV 1500 units vial:
Reconstituted solution should be clear and colourless or slightly opalescent.
Reconstituted solution is stable for 8 hours when refrigerated.
Berinert SC:
Reconstituted solution should be clear and colourless to slightly opalescent. Reconstituted solution is stable for 6 hours when stored at 15 to 30°C in the vial.
Cinryze:
Reconstituted solution should be clear and colourless or slightly blue.
Reconstituted solution is stable for 3 hours when stored between 15 to 25°C.