Description

Intratect is a solution for intravenous infusion containing human normal immunoglobulin (IVIg) at a concentration of 50 g/L, which is equivalent to a 5% solution. Each 100 mL vial contains 5 grams of immunoglobulin.

Composition

• Active Substance: Human normal immunoglobulin, with at least 96% being immunoglobulin G (IgG).

• IgG Subclass Distribution: Approximately 57% IgG1, 37% IgG2, 3% IgG3, and 3% IgG4.

• Maximum IgA Content: 900 micrograms/mL.

Indications

Intratect is used for:

• Replacement Therapy: In primary immunodeficiency syndromes (e.g., congenital agammaglobulinemia, common variable immunodeficiency) and severe secondary hypogammaglobulinemia.

• Immunomodulatory Effects: In conditions like idiopathic thrombocytopenic purpura, Guillain-Barré syndrome, and Kawasaki disease.

Dosage

The dosage regimen varies by indication:

• Replacement Therapy: Typically starts with 0.4 to 0.8 g/kg body weight, followed by maintenance doses of 0.2 to 0.8 g/kg every 3 to 4 weeks.

• Immunomodulatory Use: Doses are adjusted based on clinical response and IgG trough levels