octaplasLG® / octaplas®

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:

  • Donor screening;
  • NAT (Nucleic Acid Test) testing of the plasma pool for: HIV, HAV, HBV, HCV, HEV and PB19;
  • Immunoneutralisation;
  • Solvent/detergent treatment;
  • Ligand affinity chromatography for prion reduction (only octaplasLG®).
Indication1,2

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).
 
Presentation

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. 

 
References

1. octaplasLG® - Summary of product characteristics (EU)
2. octaplas® - Summary of product characteristics (EU)

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