What has changed?

Australian plasma. Global process.

Under the National Fractionation Agreement for Australia in place between the National Blood Authority and CSL Behring, CSL Behring has been investing in new facilities to provide expanded capacity for processing Australia’s growing annual domestic plasma collections.

CSL Behring is transitioning Australia’s human prothrombin complex product to being manufactured within these new, purpose-built manufacturing facilities in Broadmeadows, Victoria.

Australian domestic plasma products will be manufactured in Australia from plasma collected onshore by the Australia Red Cross Lifeblood but will be manufactured using CSL Behring’s innovative global manufacturing processes. As per the current products, the new products will comply with the safety and efficacy requirements set by the Therapeutic Goods Administration.

During the transition to Beriplex® (manufactured from Australian-sourced plasma) there will be a short period where the available Beriplex® will be manufactured from globally-sourced plasma. 

DifferencesProthombinex-®VFBeriplex® P/N
500 IU
Beriplex® AU
500 IU
Active ingredientsFactor II (approx. 500 IU)
Factor IX (500 IU)
Factor X (approx. 500 IU)
Factor II (400–960 IU)
Factor VII (200–500 IU)
Factor IX (400–620 IU)
Factor X (440–1200 IU)
Protein S (240–760 IU)
Protein C (300–900 IU)
DosingDosing differences between PROTHROMBINEX®-VF and BERIPLEX® include the dosing algorithm (initial International Normalised Ratio (INR) ranges, target INR and related dose), maximum single dose by INR range and inclusion of dosing in mL/kg body weight.
Rate of administrationApproximately 3 mL per minute or as tolerated by patientNot exceeding 3 IU/kg body weight/minute, max. 210 IU/minute (approximately 8 mL per minute)
Shelf life3 years
Storage conditionsStore 2–8°C (do not freeze). Can be stored below 25°C for a single period of 6 monthsStore below 25°C (do not freeze)
Plasma sourceAustraliaInternationalAustralia
Estimated date availableFrom mid 2024From mid 2024From late 2024/ early 2025*

*Variation to manufacture using Australian plasma pending regulatory approval.

BERIPLEX® indication 

Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.1

Preview Product info laptop

Product information

View the Approved Product Information for Beriplex®

Reference: 1. Beriplex® Product Information. ® PROTHROMBINEX is a registered trade mark of CSL Limited. Beriplex® is a registered trade mark of CSL Limited.

For information: CSL Behring (Australia) Pty Ltd: For Medical/Technical Inquiries: Phone: 1800 642 865. For Customer Service Inquiries: Phone: 1800 063 892. E-mail: customerservice@cslbehring.com.au. Internet: www.cslbehring.com.au. CSL Behring (Australia) Pty Ltd 655 Elizabeth Street, Melbourne, Vic, 3000. ABN: 48 160 734 761. July 2024. AU-BAU-0025. 002046.

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