Description
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
1 mL of solution contains:
Virus-inactivated human normal immunoglobulin 50mg human proteins 50g/I of which IgG at least 95%.
IgG subclasses :
IgG1 24.3 – 37.2 mg
IgG2 12.4 – 22.1 mg
IgG3 0.9 – 1.5 mg
IgG4 0.1 – 0.5 mg
Maximum IgA content 0.05mg
List of excipients
Maltose
Water for Injection
PHARMACEUTICAL FORM
Solution for Infusion
THERAPEUTIC INDICATIONS
Replacement therapy in:
Primary immunodeficiency 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