PatientsVisitorsLocations & ServicesAbout the RegionJoin Our TeamPhysicians
Find:  Locations | Services
Pathology and Laboratory Medicine HomeTest and Services CatalogueTransfusion Medicine Product CataloguePolicy and ProcedureJob AidsSpecimen Collection and TransportRequisitionsAntibiogramsGenetic Testing and Molecular GeneticsMicrobiology EssentialsTransfusion EssentialsReference RangesLaboratory SuppliesAcute Care SCM GuidelinesContact InformationPhysician Access to Patient ResultsNew Clinic or Provider Information Changes
Pathology and Laboratory Medicine
Product Catalogue

​Berinert®

Transfusion Medicine

​Class:
C1 Esterase Inhibitor, Human
​Alternate Product Name:
Berinert® 500/Berinert® 1500
​Company/Supplier:
CSL Behring Canada, Inc.
​Routes
Intravenous
Other
​Direct IV
​Intermittent
IV Infusion
​Continuous
Infusion
​Subcutaneous
Intramuscular​
Other​
​Acceptable Routes
​Yes
​Yes
​No
​No
No​
​N/A


​Description
  • Is a purified, pasteurized Nano filtered, lyophilized concentrate of human C1 esterase inhibitor (C1-INH) to be reconstituted for intravenous administration
  • It is prepared from large pools of human plasma​
​Availability
  • Vial sizes/dosages:
    • 500 units per vial reconstituted with 10 mL of diluent
    • 1500 units per vial reconstituted with 3 mL of diluent
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock available at your site​
​Indications
  • For the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity in pediatric and adult patients
  • Treatment should be initiated and supervised by a healthcare practitioner experienced in the use of coagulation agents and in the management of HAE​.
​Contraindications
  • Patients who have experienced life-threatening allergic reaction, including anaphylaxis, to constituents of the preparation
  • ​For a complete listing, see the contraindications section of product monograph
​Warnings
​Dosage
  • Dosage should be determined by a physician experienced in the care of HAE patients
  • For the treatment of acute HAE attacks of moderate to severe intensity, a dose of 20 units per kg body weight administered by intravenous injection is recommended
  • For further information about dosage please review the product monograph
  • Consult with Hematologist or Immunologist for safe dosing recommendations by paging through switchboard at (306)655-1000​
​Pre-Administration Testing Requirements
  • As directed by most responsible healthcare practitioner (MRHP)​
​Ordering
  • ​Specify type of concentrate and dosage required
  • Off-label requests must be approved by the Transfusion Medicine Medical Physician, available through RUH Switchboard (306)655-1000
  • To request product from the transfusion medicine laboratory, use the Plasma Protein Product Request Form #103221
​Forms Required
  • ​Informed Consent for Blood Components and/or Plasma Protein Products # 101479
  • Plasma Protein Product Request Form #103221
  • Transfusion/Infusion Administration and Assessment Record #103221
  • Saskatchewan Transfusion Adverse Event Report Form #103695 (only needed if adverse event occurs)
  • Notification of Administration of Blood and/or Blood Products Form #103854
  • Forms can be located in the Lab Services Manual or Forms on Demand
​Supplies Required
  • The product package contains:
    • One single-​use Berinert® vial
    • One single-use sterile water for injection vial
    • a needle-less filter transfer device called Mix2Vial for the reconstitution and withdrawal of the product
  • Additional supplies needed:
    • One luer lock syringe (appropriate size based on volume) for administration
    • Alcohol swab (for cleaning the tops of the vials)
​Administration
  • Blood consent: is required due to human plasma component
  • Pre-infusion: Ensure recent patient weight is on file and pertinent laboratory results are available
  • Perform all other appropriate pre-administration checks per protocol, detailed in the Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141

  • Administration
    Room temperature product to be given by slow intravenous injection at maximum rate of 4 mL per minute. Can be infused using the Plum 360 SMART IV pump; "blood c1 esterase" it the drug line that can be used and is found under various adult CCAs

  • For additional preparation/reconstitution and administration steps see administration section of the product monograph
  • Access: Can be given via CVC, PICC, Port-a-Cath, or peripheral IV
  • Compatible solutions: can flush line with 0.9% normal saline pre and post administration of Berinert®. Separate line for infusion is recommended. No other drugs/solutions (including normal saline) can be co-administered in the same line while Berinert® is being infused

  • Preparation and Reconstitution
    NOTE: Reconstitute only immediately before administration
    • Administer within 3 hours of reconstitution
    • DO NOT refrigerate after reconstitution
    • DO NOT further dilute in any IV solutions
    • Do not mix with other drugs or IV solutions
Use aseptic technique (clean and germ free) when preparing and reconstituting Berinert®
Allow the vials of Berinert® and diluent to reach room temperature before use. This can be done by warming of both unopened vials in your hands to a comfortable temperature or by leaving the unopened vials at room temperature for about half an hour prior to administration. Warming of the vials will ease with dissolving the powder and lessen patient discomfort in the vein when administering

​Place the Berinert® vial, diluent vial and Mix2Vial transfer set on a flat surface
​Remove Berinert® vial and diluent vial flip caps and wipe the stoppers with an antiseptic. Allow to dry prior to opening the Mix2Vial transfer set package
​Open the Mix2Vial® transfer set package by peeling away the lid (fig. 1). To maintain sterility, leave the Mix2Vial® transfer set in its clear outer package
Berinert fig 1.gif
​Place the diluent vial on an even flat surface and hold the vial tightly. Grip the Mix2Vial® transfer set keeping it in the clear package and push the plastic spike of the blue end of the Mix2Vial® transfer set firmly though the center of the diluent vial stopper (fig. 2)
Berinert fig 2.gif
​While holding the diluent vial, carefully remove the outer package from the Mix2Vial® transfer set. Make sure to pull off only the clear package, not the Mix2Vial® transfer set (fig. 3)
Berinert fig 3.gif
​Place the Berinert® vial on an even flat surface and hold the vial tight. Invert the diluent vial with the Mix2Vial® transfer set attached to it and push the plastic spike of the clear end of the Mix2Vial® firmly through the center of the stopper of the Berinert® vial (fig. 4). The diluent will transfer into the Berinert® vial automatically.
Berinert fig 4.gif
​With the diluent and Berinert® vial still attached to the Mix2Vial® transfer set, gently swirl the Berinert® vial to ensure that the Berinert® is fully dissolved (fig. 5). Do not shake the vial
Berinert fig 5.gif
​With one hand, grip the clear end of the Mix2Vial® transfer set and with the other hand grip the blue end of the Mix2Vial® transfer set, and unscrew counter clockwise the set into two pieces (fig. 6)
Berinert fig 6.gif
​Draw air into an empty, sterile syringe. With the Berinert® vial upright, Screw the syringe to the Mix2Vial® transfer set. Inject air into the Berinert® vial. While keeping the syringe plunger pressed, invert the Berinert® vial and draw the solution into the syringe by pulling the plunger back slowly
Berinert fig 7.gif
​Once the solution has been transferred into the syringe, firmly grip the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe counter clockwise from the Mix2Vial® transfer set (fig. 8). Attach the syringe to an infusion set or another suitable administration set
Berinert fig 8.gif
​If patient is to receive more than one vial, the contents of multiple vials may be pooled into a single syringe. Use a separate unused Mix2Vial® transfer set for each product vial.
  • Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP)

​Nursing Implications
​Adverse Events
​Comments
  • Contact the Saskatchewan Bleeding Disorders Program for further education and administration assistance at (306)381-4185, Monday to Friday 0800-1630​
​References


​If you choose to print this information, it is valid only on date of print.

Laboratory Controlled Document LSM-1024 v1

Last Modified: Tuesday, May 12, 2020 |
Questions or feedback about this page?