Storage Conditions Store at 2° - 8°C (Refrigerate. Do not freeze). Once removed from refrigeration, store below 25°C and use within 3 months. Protect from light. [Not disclosed specifies planned product changes ] Planned Product Changes – [Not disclosed specifies when products may be removed from Ability for a Party to remove – supply under the Deed] the Product from supply under the Deed [Not disclosed specifies when products may be added to Ability for a Party to add the – supply under the Deed] Product to supply under the Deed 37900155 CSL Product Number Product Name INTRAGAM 10 100ml Product Description Human Normal Immunoglobulin solution for intravenous injection Product Concentration Each vial nominally contains 10g of IgG Kit Items (if applicable) - ARTG Number AUST R 162488 Approved Indications Intragam 10 is indicated for replacement IgG therapy in: Primary Immunodeficiency Diseases (PID) Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam 10 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 Kawasaki disease Guillain-Barré 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
Storage Conditions Store at 2° - 8°C (Refrigerate. Do not freeze). Once removed from refrigeration, store below 25°C and use within 3 months. Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply under the Deed [Not disclosed – specifies when products may be removed from supply under the Deed] Ability for a Party to add the Product to supply under the Deed [Not disclosed – specifies when products may be added to supply under the Deed] CSL Product Number 37900155 Product Name INTRAGAM 10 100ml Product Description Human Normal Immunoglobulin solution for intravenous injection Product Concentration Each vial nominally contains 10g of IgG Kit Items (if applicable) - ARTG Number AUST R 162488 Approved Indications Intragam 10 is indicated for replacement IgG therapy in: Primary Immunodeficiency Diseases (PID) Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam 10 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 Kawasaki disease Guillain-Barré 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
Final-NaFAA-for-Website.docx