CSL New Zealand INTRAGAM 10 normal immunoglobulin (human) 2.5g/25mL solution for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

human immunoglobulin G, Quantity: 2.5 g

זמין מ:

CSL Behring Australia Pty Ltd

INN (שם בינלאומי):

human immunoglobulin G

טופס פרצבטיות:

Injection, solution

הרכב:

Excipient Ingredients: human immunoglobulin A; glycine

מסלול נתינה (של תרופות):

Intravenous Infusion

סממני תרפויטית:

Intragam 10 is indicated for replacement IgG therapy in: - primary immunodeficiency disease (PID) - myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections - congenital or acquired immune deficiency syndrome with recurrent infections. Intragam 10 is indicated for immunomodulatory therapy in: - immune 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-Barr? syndrome (GBS) - chronic inflammatory demyelinating polyneuropathy (CIDP) - multifocal motor neuropathy (MMN) - myasthenia gravis (MG) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe MG when other treatments have been ineffective or caused intolerable side effects - short-term therapy for severely affected nonparaneoplastic Lambert-Eaton myasthenic syndrome (LEMS) patients - treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

leaflet_short:

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

מצב אישור:

Licence status A

תאריך אישור:

2012-08-10