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

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
23-11-2017

Bahan aktif:

normal immunoglobulin, Quantity: 3 g

Boleh didapati daripada:

CSL Behring Australia Pty Ltd

INN (Nama Antarabangsa):

normal immunoglobulin

Borang farmaseutikal:

Injection, solution

Komposisi:

Excipient Ingredients: human immunoglobulin A; maltose

Laluan pentadbiran:

Intravenous Infusion

Unit dalam pakej:

50 mL

Jenis preskripsi:

(S1) This Schedule is intentionally blank

Tanda-tanda terapeutik:

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).

Ringkasan produk:

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

Status kebenaran:

Licence status A

Tarikh kebenaran:

2014-01-08