Gamunex-C 10% Injection, 100 mL Vial

Gamunex-C — 10GM, Injection, carton of 1 × 100 mL vial

Gamunex-C (Immune Globulin (Human)) is a injection for intravenous; subcutaneous use. GAMUNEX-C is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: GAMUNEX-C is an immune globulin injection (human), 10% liquid indicated for treatment of: Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older ( 1.1 ) Idiopathic Thrombocytopenic Purpura (ITP) in adults and children ( 1.2 ) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults ( 1.3 ) 1.1 Primary Humoral Immunodeficiency (PI) GAMUNEX-C is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.( 1-4 ) 1.2 Idiopathic Thrombocytopenic Purpura (ITP) GAMUNEX-C is indicated for the treatment of adults and children with Idiop

• Active ingredient or product type: Human Immunoglobulin G
• Strength/concentration: 10GM
• Dosage form and route: Injection, Intravenous; Subcutaneous
• Exact package presentation: carton of 1 × 100 mL vial
• NDC/item number: 13533-800-71
• Manufacturer: GRIFOLS
• Storage/handling: DO NOT FREEZE Keep the vial in the carton to protect from light. stored for 36 months at 2-8°C (36-46°F) from the date of manufacture, AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded.
• Status: Rx only

Important safety information: IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.