FLEBOGAMMA 5% DIF SOLUTION FOR INFUSION 5 % Solution for infusion 200ml Vial

Product Overview

FLEBOGAMMA 5% DIF Solution for Infusion is a highly purified preparation of human normal immunoglobulin (IVIg).

It is derived from human plasma and contains a broad spectrum of IgG antibodies found in the normal population.

This solution is specifically formulated for intravenous administration to help patients with various immune system disorders.

Benefits of Use

• Provides essential antibodies to individuals with primary immunodeficiency syndromes (PIDs), helping to prevent infections.
• Used as an immunomodulatory agent in certain autoimmune and inflammatory conditions such as Immune Thrombocytopenic Purpura (ITP), Guillain-Barré Syndrome, Kawasaki Disease, and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
• Helps to normalize or suppress an overactive immune response in specific disease states.
• Contributes to maintaining a healthy immune system balance.

How to Use

FLEBOGAMMA 5% DIF is for intravenous use only and must be administered under the supervision of a healthcare professional.

1. The dosage and rate of infusion are highly individualized and depend on the patient's condition, weight, and response to treatment.
2. The solution should be clear to opalescent and colorless to pale yellow. Do not use if the solution is turbid or contains particulates.
3. Allow the product to reach room temperature (20-25°C) before administration.
4. Administer using an intravenous infusion set with an inline filter.
5. Monitor the patient closely for any adverse reactions during and after the infusion.

Caution & Warnings

• This product is for prescription use only and must be administered by a qualified healthcare provider.
• Do not administer to individuals with a history of severe allergic reactions to human immunoglobulins or any component of the formulation.
• Patients should be adequately hydrated before the infusion, especially those at risk of renal dysfunction.
• Monitor for signs of allergic reactions, including anaphylaxis, which can occur even in patients who have tolerated previous administrations.
• Rare but serious side effects include thrombotic events (blood clots), acute kidney injury, aseptic meningitis syndrome, and hemolytic reactions.
• Inform your doctor if you have any pre-existing medical conditions, especially kidney disease, heart disease, diabetes, or a history of blood clots.
• Avoid rapid infusion rates, as this can increase the risk of adverse reactions.

Ingredients

• Active Ingredient: Human Normal Immunoglobulin 5% (50 mg/ml)
• Excipients: D-Sorbitol, Sodium Chloride, Water for Injections

Product Details

• Form: Solution for Infusion
• Strength: 5% (50 mg/ml)
• Volume: 200ml
• Packaging: Vial
• Manufacturer: Grifols
• Storage: Store below 25°C. Do not freeze. Protect from light.