Pharmaceutical Company / Marketing Authorisation Holder
DRK-Blutspendedienst West gemeinnützige Gesellschaft mit beschränkter Haftung der Landesverbände Nordrhein, Westfalen-Lippe, Rheinland-Pfalz und Saarland, Feithstr. 182, 58097 Hagen.
Designation LyoPlas N - w
Composition of the medicinal product / active ingredients (qualitative and quantitative)
Active ingredients: 0.70 to 0.85 ml/ml coagulation-promoting human plasma
Other ingredients: citrate, phosphate, glucose
- Emergency substitution in patients with clinically relevant bleeding tendencies or manifest bleeding with a complex disorder of the haemostatic system, particularly involving severe damage to the hepatic parenchyma or disseminated intravascular coagulation (DIC). Treatment of the underlying disease must take priority in all cases. As DIC always signifies a complication of a severe underlying disease (such as sepsis, shock, polytrauma), LyoPlas N - w should only be administered if the underlying pathological mechanisms are also treated.
- Coagulopathy due to blood thinning and/or blood loss
- Substitution in Factor V and Factor XI insufficiency
- Thrombotic thrombocytopenic purpura
- Exchange transfusion
- The use of LyoPlas N - w is not indicated as a volume, protein or albumin substitute, for immunoglobulin substitution or as parenteral nutrition.
- Plasma protein intolerance
- Cardiac decompensation, hypervolaemia, hyperhydration, pulmonary oedema
- Proven IgA insufficiency
- Volume overload may lead to acute heart failure with pulmonary oedema, particularly in cardiovascular diseases.
- Risk of citrate intoxication in case of rapid transfusion and/or larger volumes, particularly in hepatic dysfunction, shock, acidosis, hypothermia and in neonates.
- Transfusion related acute lung injury (TRALI).
- Anaphylactoid reactions have been observed in rare cases.
- Coagulation factor inhibitors may develop.
- The risk of bacterial contamination may never be ruled out with absolute certainty.
- When using medicinal products made from human blood, it is never possible to entirely rule out the risk of transmitting pathogens - including those of a previously unknown kind - which may subsequently cause infectious diseases. This applies to hepatitis, for example, and more rarely to the acquired immune deficiency syndrome (AIDS). In the United Kingdom sporadic cases have been reported of "causative organisms" (so-called prions) being found in recipients of blood transfusions from donors who later developed variant Creutzfeldt-Jakob disease (vCJD). vCJD may be acquired through the consumption of certain beef products made from cattle affected by BSE. So far, however, vCJD has not been observed in Germany.
are not required.
only available on prescription
For risks and side effects, please read the package insert and ask your doctor or chemist.