Transfusion medicine handbook

5. Fractionated Products

Overview

Fractionated products, also known as plasma derivatives, are partially purified therapeutic preparations of human plasma proteins. They are manufactured under pharmaceutical conditions from large volumes of donor plasma with the final products supplied as freeze-dried powders or solutions.

Careful screening of every donation contributing to a plasma pool is vital since any one donation could potentially introduce infectious agents into the pool. Even with rigorous screening of every donor and infectious diseases testing of every donation, some infectious agents might still find their way into the plasma pool. To counter this risk, manufacturing processes include two or more specific steps to inactivate any such agents that may escape detection.

Some points to note regarding transfusion of fractionated products:

• The manufacturer’s instructions should be carefully read. Specific information about the administration of each product is given in the product information sheet, which comes packaged with each unit.
• Products should be transfused promptly following issue from the blood bank. If there is any delay they must be stored in accordance with the manufacturer’s recommendations or returned to blood bank.
• Freeze-dried preparations must be infused immediately after reconstitution. Do not refrigerate after reconstitution. The majority of coagulation factors are stable for only 3-4 hours after reconstitution.
• Products not containing an antimicrobial preservative must be transfused within 4 hours of breaking the product seal. Vented infusion sets are required for solutions such as albumin and intravenous immunoglobulin.
• Multiple vials or bottles of the same product may be pooled together immediately prior to infusion to the patient.
• Products should not be used if turbidity or particulate matter is present in the vial or bottle. If observed this should be reported to NZBS.
• ABO compatibility does not normally need to be considered. Residual anti-A and anti-B in the final product are usually at clinically insignificant levels. However, in some situations, such as administration of high doses of Intravenous Immunoglobulin product to non-group O patients, there should be monitoring for signs of intravascular haemolysis.
• Patients may experience adverse reactions due to transfusion of fractionated products. These should be reported as soon as possible to NZBS using the Fractionated Blood Product – Adverse Event Notification form available at https://www.nzblood.co.nz/clinical-information/transfusion-medicine/adverse-reaction-reporting-and-management/.
• When evaluating patients with adverse reactions to immunoglobulins products, assess the rate of administration, the hydration status and the need for pre-medication (anti-histamines) prior to subsequent infusions. For more information about managing adverse events, including a possible change to the approved immunoglobulin product for a specific patient, please get in touch with an NZBS Transfusion Medicine Specialist/ Medical Officer.

The information contained within this chapter relates to the fractionated products distributed by NZBS and has been adapted from the most recently available datasheet and/or the manufacturer’s product information sheet for each product. These sources should be consulted prior to administration. Current versions of the datasheets can be accessed through the websites of NZBS (https://www.nzblood.co.nz/clinical-information/transfusion-medicine/health-professionals-medicine-datasheets/ ) and Medsafe ( ). NZBS Transfusion Medicine Specialists/Medical Officers and Transfusion Nurse Specialists can also provide valuable information regarding the use of fractionated products.