Grifols Albumin 20% is a sterile solution for intravenous injection or infusion containing Human Albumin 20%, a protein extracted from human blood plasma. It acts to expand plasma volume and maintain intravascular oncotic (colloid osmotic) pressure. It is indicated for conditions requiring volume replacement or the correction of albumin deficiency in the body. Each 50 ml vial contains 10 g of human albumin.
What is Grifols albumin used for?
Grifols Albumin 20% is indicated for:
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Treatment of hypovolemia when colloid solutions are appropriate for volume expansion.
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Treatment of hypoalbuminemia.
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Adjunctive therapy during cardiopulmonary bypass surgery.
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Management of nephrotic syndrome in selected cases at the physician's discretion.
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Treatment of ovarian hyperstimulation syndrome (OHSS).
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Adjunctive therapy for neonatal hyperbilirubinemia in specific procedures, such as exchange transfusion.
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Supportive treatment for acute respiratory distress syndrome (ARDS) in selected clinical settings.
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Prevention of hypovolemia following large-volume paracentesis in patients with liver cirrhosis.
How to Use
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Administered intravenously only by a physician or qualified healthcare professional.
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Dosage and infusion rate are determined by the physician based on clinical status, patient weight, and the degree of fluid or protein loss.
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Inspect the solution visually prior to administration; do not use if cloudy, discolored, or containing particulate matter.
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For single use only; discard any unused portion immediately after use.
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When large volumes are required, the solution should preferably be brought to room temperature before infusion.
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Do not shake the vial vigorously prior to administration.
Side Effects
Grifols Albumin may cause side effects, including:
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Facial flushing or feeling warm
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Nausea or vomiting
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Fever or chills
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Headache
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Hypertension or hypotension
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Hypervolemia (fluid overload), particularly in susceptible patients
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Allergic reactions, which in rare cases may progress to anaphylaxis requiring immediate discontinuation of infusion and appropriate medical treatment.
Precautions and Warnings
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Contraindicated in patients with a known hypersensitivity to human albumin preparations or any of the excipients.
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Use with caution in patients with heart failure, hypertension, severe renal failure, or pulmonary edema due to the risk of hypervolemia (circulatory overload).
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Monitor vital signs, hemodynamic status, and fluid and electrolyte balance closely during therapy.
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In dehydrated patients, appropriate hydration therapy should be administered concurrently as evaluated by the doctor.
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Use during pregnancy or breastfeeding only if the expected benefit clearly outweighs the potential risk.
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Do not dilute with Sterile Water for Injection, as this may lead to hemolysis; dilute only with 0.9% Sodium Chloride or 5% Dextrose solution if required.
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As a human plasma derivative, effective measures are implemented during manufacturing to minimize the risk of infectious agents; however, the risk of pathogen transmission cannot be totally excluded.
Drug Interactions
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Do not mix Grifols Albumin with other medications in the same container or infusion line unless compatibility has been established.
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Do not dilute with Sterile Water for Injection to avoid acute hemolysis.
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Inform your physician of all concurrent medications and intravenous solutions prior to treatment.
Storage
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Store at a temperature not exceeding 30°C.
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Do not freeze.
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Keep in the original container to protect from light until ready for use.
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Do not use if the solution is turbid or contains precipitates or particulates.
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Single-use vial: Once opened, use immediately and discard any remaining solution.
Ingredients
Active Ingredient:
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Human Albumin 20%, providing 10 g of human albumin per 50 ml vial.
Inactive Ingredients:
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Water for Injection
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Sodium caprylate
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Sodium acetyltryptophanate
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Sodium content: 130–160 mEq/L
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Preservative-free.
