QUALITATIVE AND QUANTITATIVE COMPOSITION
Each flacon contains 5g human globulin (IgG). [1 mL solution contains 0.05 g human plasma protein globulin (% 5)].
- Primary immunodeficiency syndromes.
- Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and recurrent 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.
- Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
- Guillain Barré syndrome.
- Kawasaki disease.
100 ml of solution in a vial, pack size of one vial.
The dose and dose regimen is dependent on the indication. In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dose regimens are given as a guideline.
MARKETING AUTHORIZATION HOLDER