ALBUMAN BERNA 20% Infusion

What is ALBUMAN BERNA 20%

ALBUMAN BERNA 20% is a sterile, hyperoncotic intravenous infusion solution containing human albumin at a concentration of 200 g/L (20%). It is prepared from pooled human plasma and undergoes strict viral inactivation processes to ensure safety. Each 100ml bottle comes with an integrated infusion set for intravenous administration.

This medication is classified as a **plasma volume expander** and is primarily used to restore and maintain circulating blood volume in cases where there is volume deficiency. It is especially beneficial in clinical conditions requiring rapid plasma expansion or when oncotic pressure needs to be restored.

Indications include:

• Hypovolemic shock due to trauma, surgery, or burns
• Liver cirrhosis with ascites (often used in large-volume paracentesis)
• Nephrotic syndrome (when unresponsive to diuretics)
• Acute hypoalbuminemia or chronic low albumin states
• Cardiopulmonary bypass procedures

Key Characteristics:

• Derived from human plasma with high safety standards (viral inactivation via pasteurization)
• Supplied as a 100ml bottle containing 20g of human albumin
• Accompanied by an infusion set for ready-to-use intravenous administration

ALBUMAN BERNA 20% must be used under medical supervision, with dosage and administration tailored according to individual patient needs and response.

How to use ALBUMAN BERNA 20%

ALBUMAN BERNA 20% should be administered intravenously under strict aseptic conditions by a trained healthcare professional. The use of the included infusion set ensures correct delivery and minimizes contamination risk.

Preparation Steps:

• Inspect the solution visually: It should be clear to slightly opalescent and free from particulates. Do not use if turbid or if the seal is broken.
• Bring the solution to room temperature before infusion.
• Use the infusion set provided. Ensure proper insertion and secure attachment before beginning infusion.

Administration Guidelines:

• Infuse intravenously using controlled drip or infusion pump.
• Infusion rate should be adjusted based on:
  • Patient's volume status and hemodynamic parameters
  • Clinical condition (e.g., hypovolemia vs. hypoalbuminemia)
• In general, a slower infusion rate is advised in elderly, patients with cardiac or pulmonary compromise, or in those at risk of volume overload.

Monitoring During Use:

• Vital signs (blood pressure, heart rate, respiration)
• Central venous pressure (if available)
• Urine output and renal function
• Signs of allergic reactions

Important: Do not mix with other IV fluids or medications in the same line unless compatibility has been confirmed. Use the entire contents of the bottle within 4 hours once opened.

Mode of Action ALBUMAN BERNA 20%

ALBUMAN BERNA 20% contains **human albumin**, a naturally occurring plasma protein synthesized by the liver. It accounts for approximately 50–60% of the total plasma protein content and plays crucial roles in fluid balance and transport functions.

Primary Mechanisms of Action:

• Oncotic Pressure Regulation: Albumin exerts colloid osmotic pressure (oncotic pressure), which pulls fluid from the interstitial space into the vascular compartment. This helps restore blood volume in hypovolemic or edematous states.
• Volume Expansion: The 20% concentration is hyperoncotic, meaning it draws extravascular fluid into the bloodstream, leading to plasma volume expansion that can be two to four times the infused volume.
• Transport Function: Albumin binds and transports various endogenous and exogenous substances including hormones, bilirubin, fatty acids, and certain drugs, aiding in systemic regulation.
• Buffering Capacity: It contributes to the plasma buffer system, helping maintain acid-base balance.

Clinical Benefits:

• Restores effective blood volume rapidly
• Improves tissue perfusion and oxygen delivery
• Helps in mobilizing edema fluid in liver cirrhosis or burns
• Reduces need for synthetic colloids or crystalloids in certain conditions

Due to its high oncotic activity, ALBUMAN BERNA 20% is especially beneficial in patients requiring fluid shift into the intravascular space while avoiding fluid overload.

ALBUMAN BERNA 20% Interactions ALBUMAN BERNA 20%

As a naturally occurring plasma protein, **Albumin (human)** has a low risk of drug interactions. However, certain pharmacodynamic and administration considerations should be taken into account when using ALBUMAN BERNA 20%.

Pharmacological Interactions:

• Drugs bound to albumin: Albumin has a high binding affinity for many medications, including warfarin, phenytoin, diazepam, and certain antibiotics. When administered in large amounts, albumin may displace these drugs from their protein-binding sites, potentially increasing their free (active) concentration.
• ACE inhibitors: Use cautiously in patients receiving angiotensin-converting enzyme (ACE) inhibitors, as there is a small risk of hypotension due to vasodilation when combined with plasma volume expansion.

Administration-Related Considerations:

• Incompatibilities: Do not mix ALBUMAN BERNA 20% with other IV solutions or medications unless compatibility has been confirmed.
• Other colloids: Caution when co-administering with synthetic colloids (e.g., dextran or hydroxyethyl starch), as the combined oncotic effect may increase risk of hypervolemia.

Monitoring Required:

• Monitor coagulation parameters and serum electrolytes when used with anticoagulants or diuretics.
• Closely observe for fluid overload when used with vasopressors or inotropes.

Always inform the healthcare provider of all ongoing medications and supplements to ensure safe administration of ALBUMAN BERNA 20%.

Dosage of ALBUMAN BERNA 20%

The dosage of ALBUMAN BERNA 20% must be individualized based on the patient’s clinical condition, severity of hypoalbuminemia or hypovolemia, and body weight. It should be guided by hemodynamic parameters, laboratory values, and response to treatment.

General Dosage Guidelines:

• Hypovolemia: 100–200 ml (20–40 g albumin) may be administered initially. If needed, doses can be repeated after clinical evaluation.
• Hypoalbuminemia: 100 ml daily or on alternate days, depending on albumin levels (typically used when serum albumin is <2.5 g/dL and accompanied by edema or other symptoms).
• Liver cirrhosis with paracentesis: 6–8 g of albumin per liter of ascitic fluid removed. For example, if 5 liters of ascitic fluid are drained, 30–40 g of albumin (150–200 ml of 20%) should be administered.
• Burns: Often started after the first 24 hours with dosage adjusted to total protein losses.

Administration Rate:

• Start slow (e.g., 1–2 ml/min) and increase based on tolerance.
• Maximum rate in adults should not exceed 3–4 ml/min unless in emergency situations.

Important Considerations:

• Do not exceed 2 g/kg body weight/day unless specifically indicated.
• Monitor serum albumin, hematocrit, electrolytes, and central venous pressure during therapy.

Possible side effects of ALBUMAN BERNA 20%

While ALBUMAN BERNA 20% is generally well tolerated, especially when administered under medical supervision, some side effects can occur. These range from mild infusion-related symptoms to rare but serious allergic or cardiovascular events.

Common Side Effects:

• Fever or chills during infusion
• Flushing or warmth
• Headache or nausea

Uncommon to Rare Side Effects:

• Hypotension: May occur if infused too rapidly or in patients on ACE inhibitors.
• Allergic reactions: Rash, urticaria, bronchospasm, and in very rare cases, anaphylactic shock.
• Volume overload: Particularly in patients with heart failure, renal impairment, or pulmonary edema.
• Electrolyte imbalances: Due to dilutional effects or fluid shifts, especially if large volumes are used.

Signs of Serious Reactions (Seek Immediate Medical Attention):

• Swelling of the face, lips, or throat
• Chest tightness or difficulty breathing
• Severe drop in blood pressure

Monitoring:

• Continuous vital sign monitoring during infusion
• Routine lab tests (serum albumin, hematocrit, and renal function)

All reactions should be documented and reported. If an adverse event occurs, infusion should be stopped immediately and appropriate treatment initiated.

ALBUMAN BERNA 20% Contraindications ALBUMAN BERNA 20%

There are specific conditions in which the use of ALBUMAN BERNA 20% is contraindicated, and others where caution is required.

Absolute Contraindications:

• Known hypersensitivity: Allergic reaction to albumin (human) or any excipients in the formulation.
• Severe anemia: Plasma expansion with albumin may further reduce hematocrit and impair oxygen delivery.
• Heart failure: Particularly in decompensated states, due to risk of fluid overload.

Relative Contraindications / Use with Caution:

• Renal impairment: Risk of hypervolemia and fluid retention
• Hypertension: May exacerbate blood pressure if infused too rapidly
• Dehydration without plasma volume deficit: Must be corrected with crystalloids before albumin is given

Other Considerations:

• Not for use as a nutritional supplement in protein deficiency
• May affect interpretation of certain lab tests (e.g., total calcium)

Prior to administration, a thorough clinical evaluation is essential to ensure appropriateness and safety of albumin therapy.

Storage of ALBUMAN BERNA 20%

Proper storage of ALBUMAN BERNA 20% is essential to maintain the product’s safety, sterility, and therapeutic efficacy.

Storage Conditions:

• Temperature: Store at 2°C to 25°C (36°F to 77°F). Do not freeze.
• Protection from light: Keep in the original package to protect from light until use.
• Do not shake: Excessive agitation may cause foaming or protein denaturation.

Handling Instructions:

• Check the solution before use. It should be clear to slightly opalescent. Do not use if turbid or if particulate matter is present.
• Use the infusion set included in the package to ensure sterility.
• Once opened, use the solution immediately. Discard any unused portion.

Disposal:

• Unused or expired medication should be disposed of in accordance with local medical waste regulations.
• Do not flush down the toilet or throw into general household waste.

Always keep this medication out of reach of children and store it in a secure medical supply area as directed by healthcare professionals.