Pharmaceutically Licensed Plasma
octaplasLG® and octaplas® are human plasma for infusion of pharmaceutical grade with standardised quality and unique safety profiles due to their integrated pathogen safety concept that represents state-of-the-art security for patients.
The standardised content in octaplasLG® and octaplas® is achieved by pooling between 630 and 1520 single plasma units from multiple donors.
The safety measures present during the manufacturing include:
NAT (Nucleic Acid Test) testing of the plasma pool for: HIV, HAV, HBV, HCV, HEV and PB19;
Ligand affinity chromatography for prion reduction (only octaplasLG®).
octaplasLG® and octaplas® are indicated in complex deficiencies of coagulation factors such as:
Coagulopathy due to severe hepatic failure or massive transfusion;
Substitution therapy in coagulation factor deficiencies, when a specific coagulation factor concentrate (e.g. factor V or factor XI) is not available or in emergency situations when a precise laboratory diagnosis is not possible.
Rapid reversal of the effects of oral anticoagulants (coumarin or indanedione type), when a prothrombin complex concentrate is not available for use or administration of vitamin K is insufficient due to impaired liver function or in emergency situations.
Potentially dangerous haemorrhages during fibrinolytic therapy, using e.g. tissue plasminogen activators, in patients who fail to respond to conventional measures.
Therapeutic plasma exchange procedures, including those in thrombotic thrombocytopenic purpura (TTP).
octaplasLG® and octaplas® are presented in 200 mL bags containing 9 - 14 g of ABO-blood group specific human plasma proteins (45 - 70 mg/mL).
They are supplied in separate presentations according to the following blood groups: A, B, AB, 0.
octaplasLG® and octaplas® must be stored and transported frozen (at ≤ -18°C) in the original package in order to protect from light. The shelf life is four years. In most European countries, five days stability after thawing has been approved.
1. octaplasLG® - Summary of product characteristics (EU)
2. octaplas® - Summary of product characteristics (EU)
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