CSL United States of America Privigen normal immunoglobulin (human) 20g (100g/L, 10%) solution for intravenous solution

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

human immunoglobulin G, Quantity: 20 g

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

human immunoglobulin G

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: proline

Administration route:

Intravenous

Therapeutic indications:

Privigen is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions. 1.1 Primary Humoral Immunodeficiency Privigen is indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. 1.2 Chronic Immune Thrombocytopenic Purpura Privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. 1.3 Chronic Inflammatory Demyelinating Polyneuropathy Privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment. Limitation of Use: Privigen maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with Privigen in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient?s response and demonstrated need for continued therapy.

Product summary:

Visual Identification: Clear or slightly opalescent and colourless or pale yellow solution; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-12-01