Product Details
GAMUNEX-C, 10%, (10000 MG), SINGLEDOSE PRESRV FREE VIAL, 1X100 ML
Manufacturer: GRIFOLS THERAPE
MFG#: 13533-0800-71
PID: 633684
Additional Information
| Product Name | Gamunex-C, 10%, (10000 Mg), Single-Dose Preservative-Free Vial, 1X 100 mL |
| Active Ingredient | Human Immunoglobulin G (IgG) |
| Mechanism of Action | Provides passive immunity by supplying functional antibodies; modulates immune response in autoimmune disorders |
| Concentration | 10% |
| Strength | 10000 mg per 100 mL vial |
| Route of Administration | Intravenous (IV) and Subcutaneous (SC for PI only) |
| Dosing Frequency | Based on indication: typically every 3 to 4 weeks for PI and CIDP, short-term for ITP |
| Common Side Effects | Headache, fever, nausea, fatigue, infusion site reactions |
| Serious Risks | Thrombosis, aseptic meningitis, hemolysis, renal dysfunction |
| Precautions | Monitor renal function, hydration status, and thrombotic risk |
| Monitoring Parameters | IgG levels, renal function, hemolysis markers, infusion reactions |
| Storage Conditions | Refrigerate at 2°C to 8°C (36°F to 46°F); do not freeze |
| Packaging | Single-use vial |
| Usage | Immunoglobulin replacement in PI, platelet modulation in ITP, immune regulation in CIDP |
Description
Gamunex-C 10% is a sterile, preservative-free immune globulin (IgG) solution for intravenous (IV) and subcutaneous (SC) administration. It is composed of purified human immunoglobulin G, derived from pooled plasma. It is indicated for the treatment of primary immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).
In patients with primary immunodeficiency, Gamunex-C provides essential antibodies to prevent recurrent bacterial infections. Regular infusions help maintain adequate IgG levels, reducing susceptibility to respiratory and systemic infections. For idiopathic thrombocytopenic purpura, it increases platelet counts by modulating immune activity, preventing excessive platelet destruction in patients with chronic or acute forms of the disease.
For chronic inflammatory demyelinating polyneuropathy, Gamunex-C is used as an immunomodulatory therapy to reduce nerve inflammation, improve motor function, and slow disease progression. The subcutaneous route is only indicated for primary immunodeficiency, while intravenous administration is used for all approved indications.
Frequently Asked Questions (FAQs)
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GAMUNEX-C, 10%, (10000 MG), SINGLEDOSE PRESRV FREE VIAL, 1X100 ML is manufactured by GRIFOLS THERAPE.
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