CSL Malaysia Intragam P Normal Immunoglobulin (Human) 6% w/v (60 g/L) Solution for Intravenous Use

Active ingredient:

normal immunoglobulin, Quantity: 3 g

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: human immunoglobulin A; maltose

Administration route:

Intravenous Infusion

Units in package:

50 mL

Prescription type:

(S1) This Schedule is intentionally blank

Therapeutic indications:

Intragam P is indicated for replacement IgG therapy in: * primary immunodeficiency (PID); * myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; * congenital or acquired immune deficiency syndrome with with recurrent infections; * congenital or acquired immune deficiency syndrome with recurrent infections. Intragam P is indicated for immunomodulatory therapy in: * Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count; * allogeneic bone marrow transplantation; * Kawasaki disease; * Guillain-Barre Syndrome (GBS).

Product summary:

Visual Identification: A clear or slightly opalescent and colourless or pale yellow liquid.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-01-08