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Albuked™ 25 (Albumin) 25% | 50mL Injectable SDV

KED-76125079225
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Kedrion Biopharma

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Albuked™ 25 is a sterile, concentrated solution of human albumin, formulated at 25% concentration, specifically designed for intravenous administration. It is supplied in a 50mL single-dose vial (SDV), providing a high-concentration source of albumin, a vital protein found in human plasma. Albuked™ 25 is commonly used in clinical settings for treating patients with conditions requiring plasma volume expansion or replacement.

Key Features:

  1. High-Concentration Albumin Solution:
  • Contains 25 grams of human albumin per 100mL, providing a potent dose in a small volume. The 50mL vial contains 12.5 grams of albumin, offering flexibility in dosing and administration.

Therapeutic Use:

  • Albuked™ 25 is primarily used for volume expansion in conditions such as hypovolemia, shock, burns, and hypoalbuminemia. It also serves as an adjunct in cardiopulmonary bypass procedures and can be used to treat acute nephrosis and hemolytic disease of the newborn.

Human Plasma-Derived Protein:

  • Derived from human plasma, this product undergoes rigorous screening and purification processes to ensure safety and efficacy. It is heat-treated and pasteurized to inactivate potential pathogens, including viruses.

Sterile and Pyrogen-Free:

  • The solution is sterile and non-pyrogenic, minimizing the risk of infection and adverse reactions when administered intravenously.

Single-Dose Vial (SDV):

  • Provided in a single-dose vial, which is intended for one-time use only, reducing the risk of contamination and ensuring the sterility of each dose.

Indications: Albuked™ 25 is indicated for:

  • Treatment of hypovolemic shock, especially when crystalloid solutions are not sufficient.
  • Management of hypoalbuminemia due to liver disease, renal disease, or other conditions.
  • Use in therapeutic plasmapheresis or large-volume paracentesis.
  • Adjunct treatment in hemodialysis, acute respiratory distress syndrome (ARDS), and cardiopulmonary bypass surgery.

Contraindications and Precautions:

  • Contraindications: Known hypersensitivity to albumin or any component of the product, severe anemia, or cardiac failure where volume overload is a concern.
  • Precautions: Use with caution in patients with preexisting cardiac or renal conditions, as albumin can expand plasma volume, potentially leading to fluid overload.

Possible Side Effects: Potential side effects may include:

  • Allergic or hypersensitivity reactions (e.g., rash, fever, chills)
  • Hypotension or hypertension
  • Nausea, vomiting, or headache
  • Fluid overload, particularly in patients with compromised cardiac function

Storage and Handling:

  • Store at controlled room temperature, protected from light.
  • Do not freeze. Discard any unused portion of the vial, as it is intended for single use only.

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Albuked™ 25 (Albumin) 25% | 50mL Injectable SDV

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