Flebogamma 5% DIF Solution for Infusion 50ml Vial

Flebogamma 5% DIF is a highly purified preparation of human normal immunoglobulin for intravenous administration (IVIg). This sterile, pyrogen-free solution is derived from human plasma and contains a broad spectrum of IgG antibodies found in the normal human population. It is specifically formulated to provide comprehensive immune support and modulation for various medical conditions.

Flebogamma 5% DIF is manufactured by Grifols, a global leader in plasma-derived medicines, ensuring high standards of quality and safety. Each 50ml vial contains 5% human normal immunoglobulin, designed for effective therapeutic intervention in a hospital or clinical setting.

Benefits of Use:

• Immune System Support: Provides essential antibodies to patients with primary or secondary immunodeficiency syndromes, helping to restore and maintain adequate immune function.
• Immunomodulatory Effects: Modulates the immune system in autoimmune and inflammatory disorders, such as Immune Thrombocytopenic Purpura (ITP), Kawasaki disease, Guillain-Barré Syndrome (GBS), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
• Broad-Spectrum Protection: Contains a wide range of antibodies that help protect against various bacterial and viral infections.

How to Use:

1. Flebogamma 5% DIF is intended for intravenous infusion only and must be administered by a qualified healthcare professional.
2. The dosage and infusion rate will be determined by the physician based on the patient's individual condition, weight, and the specific indication for treatment.
3. Ensure the solution is at room temperature before administration. Do not shake the vial.
4. Inspect the solution visually for particulate matter or discoloration prior to administration. Do not use if turbid or discolored.
5. Administer through a separate infusion line. Do not mix with other medicinal products.

Caution & Warnings:

• Allergic Reactions: Patients may experience hypersensitivity or allergic reactions, including anaphylaxis. Have epinephrine and other emergency measures readily available.
• Renal Dysfunction: Acute renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur. Ensure patients are adequately hydrated prior to infusion, especially those at risk.
• Thrombotic Events: Thrombotic events have been reported. Administer at the minimum dose and infusion rate practicable. Assess patient risk factors for thrombosis.
• Aseptic Meningitis Syndrome (AMS): AMS may occur, typically within several hours to 2 days following IVIg treatment.
• Hemolysis: IVIg products can contain blood group antibodies which may act as hemolysins. Monitor for signs of hemolysis.
• Fluid Overload: Monitor patients for signs of fluid overload, particularly those with pre-existing cardiac or renal conditions.
• Infectious Agents: Although steps are taken to reduce viral transmission, potential for transmission of infectious agents cannot be completely ruled out.

Ingredients:

Each 1ml of Flebogamma 5% DIF contains:

• Human Normal Immunoglobulin: 50 mg (5%)
• D-Sorbitol: 50 mg
• Water for Injections: q.s.

Product Details:

• Manufacturer: Grifols
• Dosage Form: Solution for Infusion
• Strength: 5% (50 mg/ml)
• Volume: 50 ml per vial
• Active Ingredient: Human Normal Immunoglobulin
• Storage: Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.
• Legal Status: Prescription Only Medicine (Rx)