|
TRANSITION UPDATE: The first of the replacement products have now been approved for supply in Australia by the Therapeutic Goods Administration:
ALBUREX 20 AU which will be replacing Albumex 20 PRIVIGEN AU which will be replacing Intragam 10
In preparation for the introduction of ALBUREX 20 AU and PRIVIGEN AU the products have been placed in the BloodNet User Acceptance Testing (UAT) and System Integration Testing (SIT) environments. Facilities are asked to add the BloodNet Product IDs to their Laboratory Information System to enable the products to be received into stock, and scan the test barcodes to ensure your system is configured to read them. The BloodNet Product IDs are in the table below.
Sample barcodes for both products can be found here:
Note that your barcode scanners need to be programmed to the GS1 standard to read a GS1 2D DataMatrix barcode. Programming them to the standard will mean they can read any GS1 2D DataMatrix barcode regardless of the order of the GTIN, batch number and expiry. This will allow GS1 barcodes of other suppliers to also be read. More details on the transition of these two products will be released shortly however it is likely to commence:
from early April 2023 for ALBUREX 20 AU from mid-late April 2023 for PRIVIGEN AU.
|
On 19 May 2022 the National Blood Authority announced that five of Australia’s domestic plasma products will be changing.
Will this product change affect me?
The following products are being replaced during calendar years 2023 and 2024:
INTRAGAM 10 (10% intravenous immunoglobulin)
EVOGAM (16% subcutaneous immunoglobulin)
ALBUMEX 4 (4% albumin)
ALBUMEX 20 (20% albumin)
PROTHROMBINEX-VF (prothrombin complex concentrate containing clotting factors II, IX and X)
What are the new products?
Some information on the replacement products which are undergoing registration with the Therapeutic Goods Administration (TGA) are in the table below. CSL Behring is developing educational material that will be made available on its website once this registration process is completed for each product. The Additional Resource section below will be updated with links to this material as it becomes available.
The products are clinically comparable to the current products, will continue to be manufactured from Australia’s plasma, and assessed by the TGA in accordance with the usual high standards of safety and effectiveness.
Summary of product changes (subject to TGA approval)
|
Current Plasma Product |
Replacement Plasma Product |
Replacement Product Presentations |
Replacement Product Storage Conditions |
Replacement Product Shelf Life |
Expected Timing for Introduction to Hospitals |
|
ALBUMEX 20 (20% albumin) |
ALBUREX 20 AU* (20% albumin manufactured using the ALBUREX process) |
100mL, 20g 50mL, 10g |
Store below 25°C Do not freeze. Protect from light. | 36 months |
March 2023
New timing - early April 2023. |
|
INTRAGAM 10 (10% intravenous immunoglobulin) |
PRIVIGEN AU* (10% intravenous immunoglobulin manufactured using the PRIVIGEN process) |
200mL, 20g 100mL, 10g 50mL, 5g
|
Store below 25°C. Do not freeze. Protect from light. |
36 months |
April 2023#
New timing - mid-late April 2023. |
|
EVOGAM (16% subcutaneous immunoglobulin) |
HIZENTRA AU* (20% subcutaneous immunoglobulin manufactured using the HIZENTRA process) |
20mL, 4g 5mL, 1g |
Store below 25°C. Do not freeze. Protect from light. |
30 months |
May 2023# |
|
ALBUMEX 4 (4% albumin) |
ALBUREX 5 AU* (5% albumin manufactured using the ALBUREX process) |
500mL, 25g 250mL, 12.5g |
Store below 25°C. Do not freeze. Protect from light. |
36 months |
October 2023# |
|
PROTHROMBINEX-VF (prothrombin complex concentrate containing clotting factors II, IX and X) |
BERIPLEX AU* (prothrombin complex containing clotting factors II, VII, IX and X manufactured using the BERIPLEX process) |
500IU FIX |
Store below 25°C. Do not freeze. Protect from light. |
36 months |
Mid 2024# |
* the AU denotes the product is manufactured from plasma collected in Australia.
# timing is subject to TGA approval of the replacement product
Why are the products changing?
CSL Behring is expanding its manufacturing facility to support the processing of Australia’s growing plasma collections into plasma products. As part of this expansion CSL Behring will be changing how it manufactures these products to be in line with its global manufacturing processes. This alignment brings efficiencies that come from being part of the standardised global process and the opportunity to directly benefit from CSL Behring’s global investment in research and development.
When are the products changing?
The product transitions will be occurring during 2023 and 2024 with the first of the products expected to become available from April 2023. The timings shown in the table above are indicative and will depend on TGA approval for each product.
Further advice will be provided closer to the implementation date regarding ordering and inventory transition arrangements.
What do I need to do?
Hospitals and clinicians need to start preparing for the product changes by updating relevant protocols and systems.
Detailed information on the replacement products will be available on the CSL Behring website with links added to the Additional Resource section as each product is registered with the TGA.
Sample barcodes of the replacement products can also be found on the NBA website here. Some information systems may need to be updated as the format of the barcode for these products will only include a GS1 DataMatrix and human readable information as the Codabar format will be removed to meet international standards. This change is in line with other similar products supplied under the national blood arrangements and is in accordance with the relevant barcode specifications.
Clinicians who have patients that use the products that are no longer being manufactured are encouraged to discuss the change with their patients.
BloodSTAR and BloodNet records will be updated by the NBA prior to supply of the replacement products.
Where can I find out more information?
As each replacement product is registered, educational material will be available on the CSL Behring website and distributed by CSL Behring to hospitals. This material will include information on key differences between the existing and replacement products and information on dosing and administration.
For medical information please direct queries to the CSL Behring medical team on medicalinformation@cslbehring.com.au or 1800 642 865.
Queries can also be directed to your local Lifeblood Medical Services.
General queries can be directed to Supply.Management.Plasma@blood.gov.au or 13 000 BLOOD (13 000 25663).
Alburex 20 AU approved Product Information
Privigen AU approved Product Information
Switching Immunoglobulin Products Pamphlet
Related NBA announcements
Print
Email this page