Description

Albumin 100: Your Solution for Critical Plasma Protein Support

Albumin 100 is a highly purified, sterile, and pyrogen-free solution of human serum albumin, specifically formulated at a 10% (100 mg/mL) concentration. Derived from pooled human plasma, it is a vital therapeutic agent designed to restore and maintain plasma volume, stabilize oncotic pressure, and facilitate the transport of essential substances throughout the body in critically ill patients.

Engineered with advanced purification and viral inactivation technologies, Albumin 100 offers a reliable and safe option for healthcare professionals requiring rapid and effective albumin supplementation.

Key Features

• Human Plasma Derived: Sourced from carefully screened human plasma donors, ensuring physiological compatibility.
• 10% (100 mg/mL) Concentration: A highly concentrated solution ideal for situations requiring less fluid volume while delivering significant albumin.
• Sterile & Pyrogen-Free: Meticulously processed to meet the highest standards of sterility and patient safety.
• Advanced Viral Inactivation: Undergoes a multi-step viral inactivation and removal process (e.g., pasteurization, caprylate stabilization) to minimize the risk of pathogen transmission.
• Physiological pH: Formulated to maintain a pH compatible with human blood, reducing the risk of infusion reactions.
• High Purity: Contains over 96% albumin, minimizing the presence of non-albumin proteins.
• Hyperoncotic Solution: Exerts a plasma-expanding effect greater than its infused volume, drawing interstitial fluid into the circulation.

Therapeutic Indications

Albumin 100 is indicated for the restoration and maintenance of circulating blood volume where a deficit has been demonstrated, and the use of a colloid is appropriate. Specific indications include:

• Hypovolemic Shock: Due to acute blood loss, trauma, or severe burns.
• Hypoalbuminemia: Conditions leading to critically low albumin levels such as:
  • Severe liver disease (cirrhosis)
  • Nephrotic syndrome
  • Severe malnutrition
  • Critical care patients with sepsis or severe inflammatory response
• Severe Burns: To replace lost plasma volume and maintain oncotic pressure.
• Acute Respiratory Distress Syndrome (ARDS): As part of fluid management strategies.
• Acute Pancreatitis: In selected cases to manage fluid shifts.
• Support During Plasmapheresis: To replace protein loss during plasma exchange procedures.
• Surgical Procedures: As part of fluid resuscitation protocols in specific high-risk surgeries.
• Ascites Management: In conjunction with paracentesis for patients with chronic liver disease.

Benefits of Albumin 100

• Rapid Plasma Volume Expansion: Effectively increases circulating blood volume, crucial in managing hypovolemic states.
• Restoration of Oncotic Pressure: Counteracts fluid extravasation, helping to reduce edema and maintain intravascular volume.
• Enhanced Transport Capacity: Replenishes albumin, which acts as a vital carrier protein for hormones, fatty acids, drugs, and other endogenous and exogenous substances.
• Support for Organ Function: By stabilizing hemodynamics and improving fluid balance, it supports vital organ perfusion and function.
• Proven Safety Profile: Rigorous viral inactivation and quality control measures ensure a high level of product safety.
• Versatile Therapeutic Tool: Applicable across a wide range of critical care and surgical scenarios.

Product Specifications

• Composition: Human Serum Albumin 10% (100 mg/mL)
• Excipients: Sodium Chloride, Sodium Caprylate, Sodium N-acetyltryptophanate, Water for Injection.
• Source: Pooled Human Plasma.
• Viral Inactivation: Pasteurization (60°C for 10 hours), Caprylate stabilization.
• pH: 6.4 - 7.4
• Sodium Content: Approximately 145 mmol/L.
• Osmolality: Hyperoncotic (approx. 2.5 times that of plasma).
• Appearance: Clear, slightly viscous liquid; color may range from pale yellow to amber.
• Packaging: Available in various single-dose glass vials (e.g., 50 mL, 100 mL).

Administration & Dosage

Albumin 100 must be administered intravenously ONLY.

• Dosage: The dose and infusion rate should be individualized based on the patient's clinical condition, diagnosis, body weight, and response to treatment. It should be determined by a qualified healthcare professional.
• Administration: Administer at room temperature using sterile, pyrogen-free equipment. Do not dilute with water for injection as this may cause hemolysis in recipients.
• Monitoring: Close monitoring of hemodynamic parameters, fluid balance, electrolyte levels, and renal function is essential during and after infusion.

Important Safety Information

Prescription Use Only.

• Contraindications: Severe anemia, decompensated cardiac insufficiency, known hypersensitivity to albumin preparations or any of the excipients.
• Warnings:
  • Risk of circulatory overload: Especially in patients with cardiac or renal impairment. Monitor for signs of hypervolemia (e.g., pulmonary edema).
  • Allergic reactions: Although rare, hypersensitivity reactions can occur. Discontinue infusion immediately if symptoms appear.
  • Electrolyte disturbances: May alter electrolyte balance; monitor carefully.
  • Infectious agents: Despite rigorous viral inactivation, a theoretical risk of transmitting infectious agents cannot be completely excluded when products derived from human blood or plasma are administered.
• Drug Interactions: No specific interactions with other medicinal products are known. However, concurrent administration of other fluids or medications should be carefully evaluated.
• Pregnancy & Lactation: Use with caution; consult a physician.

Packaging & Storage

• Presentation: Single-dose glass vials (e.g., 50 mL, 100 mL).
• Storage: Store at 2°C to 25°C (36°F to 77°F).
• Protection: Protect from light.
• Shelf Life: Refer to the expiration date printed on the label.
• Handling: Do not freeze. Do not use if the solution is cloudy, contains particulates, or if the seal is broken. Discard any unused portion.

Why Choose Albumin 100?

Albumin 100 represents a cornerstone in critical care and fluid management. Its high concentration, stringent safety protocols, and broad therapeutic utility make it an indispensable tool for healthcare providers. By reliably restoring plasma volume, stabilizing oncotic pressure, and supporting vital physiological functions, Albumin 100 helps optimize patient outcomes in the most challenging clinical scenarios.

Disclaimer: This product description is intended for informational purposes only and does not constitute medical advice. Albumin 100 is a prescription medication and should only be administered by qualified healthcare professionals under appropriate medical supervision. Please refer to the full prescribing information and consult with a physician for specific dosage, indications, contraindications, warnings, and precautions.