Flexbumin 20% Infusion 100ml Injection ( Pouch Pack )

Flexbumin 20% Infusion 100ml Injection contains Human Albumin 20%, which is used to restore and maintain circulating blood volume and treat low blood albumin levels.

Benefits

Human albumin helps draw fluid from the spaces between cells into the blood vessels, thereby increasing the volume of circulating blood and maintaining adequate blood pressure. This action also improves tissue perfusion and helps prevent complications that can arise from insufficient blood flow to tissues.

Uses and Indications

• Hypovolemia (decreased blood volume) resulting from severe blood loss due to trauma, surgery, or hemorrhage.
• Low blood protein levels (hypoalbuminemia) caused by severe injuries, infections, or pancreatitis, especially when nutritional supplements are insufficient.
• Blood volume deficiency associated with severe burns.
• Treatment of edema in patients with severe nephrosis who are also receiving steroids and/or diuretics.
• Support during cardiopulmonary bypass surgery.
• Management of hemolytic disease of the newborn (HDN).
• Addressing fluid redistribution issues in critically ill patients.

The Flexbumin 20% Infusion 100ml Injection contains:

• Human Albumin 20% (20 g per 100 mL) as the active ingredient.
• Stabilizers: N-acetyltryptophan (0.016M) and sodium caprylate (0.016M).
• Sodium content: 145 ± 15 mEq/L.
• This solution contains no preservative.

Dosage and Administration

1. Flexbumin 20% Infusion 100ml Injection is for intravenous use only and must be administered under the direct supervision of a healthcare professional.
2. The specific dose and infusion rate will be determined by the doctor based on the patient's body weight, the severity of the injury or illness, and ongoing fluid and protein losses.
3. The daily dose should not exceed 2 g of albumin per kg of body weight. For patients with normal blood volume, the infusion rate should not exceed 1 mL/min to prevent circulatory overload.
4. Do not dilute this product with Sterile Water for Injection, as this can lead to potentially fatal hemolysis and acute renal failure. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
5. Before administration, visually inspect the solution for particulate matter and discoloration. Do not use if the solution is turbid or if the Pouch Pack container shows any leaks.
6. Once the container has been entered, the contents must be used within 4 hours, and any unused portion must be discarded.

Storage and Disposal

• Store Flexbumin 20% Infusion at room temperature, not exceeding 25°C (77°F).
• Protect the product from freezing.
• Keep this medicine out of the reach of children.

Precautions and Safety

• Flexbumin 20% Infusion 100ml Injection is contraindicated in patients with a known history of hypersensitivity reactions to albumin preparations or any of its excipients (N-acetyltryptophan and sodium caprylate).
• It is also contraindicated in patients with severe anemia or cardiac failure who have normal or increased intravascular volume.
• Close monitoring of hemodynamic parameters, including blood pressure, pulse rate, central venous pressure, urine output, electrolytes, and hematocrit/hemoglobin, is essential during administration to prevent circulatory overload and hyperhydration.
• The infusion should be stopped immediately if any clinical signs of cardiovascular overload, such as headache, dyspnea, jugular vein congestion, or increased blood pressure, are observed.
• Use with caution in conditions where hypervolemia or hemodilution could pose a special risk, including decompensated cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, and renal and post-renal anuria.
• Inform your doctor if you are pregnant or breastfeeding, as the safety of Flexbumin during pregnancy and lactation has not been fully established.
• As Flexbumin is derived from human plasma, there is an extremely remote theoretical risk of transmitting viral diseases or Creutzfeldt-Jakob disease (CJD), despite rigorous donor screening and manufacturing processes.
• It is strongly recommended to record the name and batch number of the product each time it is administered to a patient for traceability.

Side Effects and Risks

• Common side effects reported include flushing, nausea, vomiting, chills, and fever (pyrexia).
• Other reported adverse reactions include headache, dysgeusia, myocardial infarction, atrial fibrillation, tachycardia, hypotension, pulmonary edema, dyspnea, urticaria, rash, and pruritus.
• Serious adverse reactions can include hypersensitivity reactions, including anaphylactic shock, and pulmonary edema.
• Circulatory overload is a potential risk that can lead to conditions such as pulmonary edema.
• Electrolyte imbalances may also occur during treatment.

Disclaimer

Use this medicine only under the prescription and guidance of a qualified doctor or pharmacist.