Intratect® is a new generation of Biotest human intravenous immunoglobulin which uses cation exchange chromatography and nanofiltration in the manufacturing process. The active substance of Intratect® is human immunoglobulin for intravenous administration. Intratect® is manufactured from blood donated by a broad spectrum of the population and is likely to contain antibodies to most common infectious diseases. Adequate doses of Intratect® can restore normal values when blood levels of Immunoglobulin G are low.
Intratect® contains 50 g/l human plasma proteins of which at least 96 % is immunoglobulin G (IgG). The IgG subclass distribution is approx. 57% IgG1, 37% IgG2, 3% IgG3 and 3% IgG4. The maximum immunoglobulin A (IgA) content is 2000 micrograms/ml. The other ingredients are: glycine and water for injections.
Intratect® is used in adults, and children and adolescents (0-18 years) who do not have sufficient antibodies (replacement therapy) in cases of patients born with lack of antibodies (primary immunodeficiency syndromes) such as:
- Hypogammaglobulinemia and repeated bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and repeated bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation.
- Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).
- Congenital AIDS with recurrent bacterial infections.
Intratect® is also used in adults, and children and adolescents (0-18 years) to treat inflammatory disorders (immunomodulation) such as:
- Primary immune thrombocytopenia (ITP, where a patient has reduced blood platelets) when the patient will have surgery in the near future or is at risk of bleeding
- Guillain-Barré syndrome (a disease that damages the nerves in the whole body)
- Kawasaki disease (a disease in children which causes inflammations of several organs of the body and where the arteries in the heart become enlarged)
Please refer to the full prescribing information for more details.