Human normal immunoglobulin, (IVIg)
Active substance: Human normal immunoglobulin (IVIg).Therapeutic indications: Replacement therapy in
- Primary immunodeficiency (PID) syndromes such as:
– congenital agammaglobulinaemia and hypogammaglobulinaemia
– common variable immunodeficiency
– severe combined immunodeficiency
– Wiskott Aldrich syndrome
- Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
- Children with congenital AIDS and recurrent infections.
Allogeneic bone marrow transplantation Description:
- Immune thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.
- Guillain-Barré syndrome.
- Kawasaki disease.
Privigen is a polyvalent immunoglobulin designed for IVIG.
One ml contains, human plasma, protein 100 mg (purity of at least 98% IgG).
- Plasma collection: Plasma currently used to manufacture Privigen comes from donors in the US, Germany, Austria, Denmark and Switzerland. CSL Behring has an
Integrated Safety System in place to ensure that all of its plasma products, including Privigen meet the highest safety standard possible. In addition to our own rigorous supervision, our centers are subjected to continual inspections by authorities.
- Pathogen safety: Privigen is based on the proven combination of three pathogen elimination methods: virus inactivation under acidic conditions, virus filtration (nanofiltration) and partitioning. The virus filtration step has been enhanced by using novel filters capable of removing viruses as small as 20 nm.
- The main virus of concern for human plasma-derived products asr human immunodeficiency virus (HIV-1 and HIV-2), the hepatitis A, B and C viruses (HAV, HBV and HCV), and the B19 virus (formerly named parvovirus B19).
- The safety of Privigen is based on five criteria
- Careful selection of donors
- Screening of donations
- Testing of plasma pools
- Including steps in the manufacturing process to eliminate or inactivate pathogens that might still present despite the three first steps
- Strict adherence to current Good Manufacturing Practice (GMP) and Quality Assurance (QA) measures
Pharmaceutical form and packs:
Privigen is available as a solution for injection, 100 mg/ml in packs of:
One vial of 25 ml contains: 2,5 g
One vial of 50 ml contains: 5 g
One vial of 100 ml contains: 10 g
One vial of 200 ml contains: 20 g
One vial of 400 ml contains: 40 g
Further product information can be ordered via firstname.lastname@example.org or visit our international product website
Privigen.com. Please note that this is an international site and some of the information may not apply in the Nordic region.
For further product information in Norwegian, please see the link below.
Felleskatalogtekst og SPC, Privigen
Last Updated: 21.03.2016