Albunorm 20%

Selected form

Human Albumin

Method of action: Anabolic, Deficit Of Proteins

Treatment option: Hypoproteinemia, Acute Pancreatitis, Edema, Cerebral Edema, Pancreatitis, Cirrhosis, Shock, Peptic Ulcer

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Albunorm 20%

Property	Description
Active ingredient	Human Albumin (Albumin Human)
Form	Solution for Infusion
Pharmacological class	Blood Substitutes and Plasma Protein Fractions (ATC Code: B05AA01)
Common purpose	Stabilizing circulating blood volume and maintaining fluid balance
Origin	Plasma Derivative (sourced from human plasma)

What Type of Medication is Albunorm 20%?

Albunorm 20% is classified pharmacologically as a Plasma Protein Fraction and a high-level Blood Substitute, widely recognized for its efficacy as a Colloid Plasma Expander. Its sole active ingredient is Human Albumin, a naturally occurring Globular Protein essential to the stability of the circulatory system. This medication is formally identified as a Plasma Derivative, meaning the Human Albumin is meticulously sourced and purified from pooled human plasma, which distinguishes it as a critical biological product. It is administered exclusively by the Intravenous (IV) route, a standard characteristic of Blood Substitutes used to directly affect the systemic circulation in critically ill patients.

Composition and Pharmaceutical Form: The Hyperoncotic 20% Solution

The medication is supplied as a sterile Solution for Infusion, presented in a concentrated form known specifically as a 20% solution (or 200 grams per liter). This concentration is officially classified as a Hyperoncotic Solution, signifying that the amount of Human Albumin protein suspended in the Water for Injections base is substantially higher than the concentration typically found in healthy blood plasma. Human albumin solutions are categorized within the therapeutic group of plasma volume substitutes and plasma protein fractions. The formulation contains minimal stabilizers, including small amounts of Sodium Chloride, N-Acetyl-DL-tryptophan, and Caprylic Acid, ensuring the stability and integrity of the active ingredient before administration.

General Purpose of Albumin as a Colloid Expander

The fundamental purpose of Albunorm 20% is to serve as an agent that restores fluid balance and stabilizes the circulating blood volume. Pharmacological studies confirm that the core principle involves generating high Colloid Oncotic Pressure (COP), utilizing the Human Albumin protein to effectively retain or draw fluid from surrounding body tissues back into the blood vessels. The protein's mechanism for increasing volume is highly effective, as human albumin is responsible for a significant portion of the colloid osmotic pressure of normal plasma. This physiological action establishes the medication's primary role as a potent Plasma Expander, providing essential volume support and critical transport functionality within the bloodstream, a measure often implemented to correct severe protein deficiency.

Regulatory References

What side effects are possible with Albunorm 20%?

Possible side effects and safety information

The safety profile of Albunorm 20% (Human Albumin) is defined by officially documented adverse reactions that are generally mild and transient, alongside specific, critical risks related to the drug's function as a high-concentration plasma expander.

Adverse Reaction Frequencies

Most documented adverse reactions are categorized as rare (affecting up to 1 in 1,000 people). These typically include mild reactions like flushing, urticaria (hives), pyrexia (fever), and nausea. If such mild reactions occur, regulatory documents note that they normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped.

Severe reactions, such as a state of shock due to a severe hypersensitivity response, are classified as very rare (affecting fewer than 1 in 10,000 people).

Serious Adverse Reactions and Safety Constraints

The official labeling documents the potential for serious adverse reactions that affect major organ systems, including anaphylactic shock, cardiac failure, circulatory failure, and pulmonary oedema. These cardiovascular events are often linked to the core safety constraint of the 20% solution: the high hyperoncotic concentration can lead to hypervolaemia (circulatory overload) if not carefully managed.

As a human plasma derivative, the product carries a theoretical risk for the transmission of infectious agents, though this risk is considered extremely remote due to extensive manufacturing controls mandated by regulatory authorities.

Special Population Notes

The safety of the solution in pregnancy has not been established in controlled trials, yet clinical experience suggests no harmful effects on the course of pregnancy or the neonate are expected. Caution is noted for patients with conditions where volume increase poses a special risk, such as those with decompensated cardiac insufficiency or renal and post-renal anuria.

Overdose and Emergency Response

Albunorm 20% Overdose and when to seek help

Overdose with Albunorm 20% is defined in regulatory documents by the development of circulatory volume overload, formally known as Hypervolemia. This condition arises when the infusion rate or dosage exceeds the patient’s capacity to manage the increased plasma volume, causing Cardiovascular Overload.

Documented Overdose Manifestations

The officially documented presentations of this overdose state include signs such as Headache, Dyspnea (Shortness of Breath), Increased Blood Pressure, Tachycardia, and noticeable Jugular Vein Distention. If unchecked, the physiological consequences of severe circulatory overload may progress to a life-threatening outcome, specifically Pulmonary Edema (fluid in the lungs).

Emergency Actions and Required Monitoring

Immediate medical attention is required upon observing the first clinical signs of Cardiovascular Overload. The mandated emergency action, as described in official labeling, is to stop the infusion immediately. The rate of infusion may be slowed down in cases of mild overload. No specific antidote is known. Management involves symptomatic and supportive treatment alongside careful monitoring of hemodynamic parameters, including Central Venous Pressure and Urine Output.

Overdose Context and Risk Factors

The regulatory information notes that certain patients are at special risk of developing severe hypervolemia. These populations include individuals with Decompensated Cardiac Insufficiency (Heart Failure), Arterial Hypertension, Pre-existing Pulmonary Edema, or Severe Anemia.

Therapeutic Uses of Albunorm 20%

Albunorm 20% is used to provide supportive therapeutic benefit by addressing fluid balance and circulation in contexts involving acute, severe symptom patterns. It is commonly used to help manage life-threatening symptom patterns and conditions where a colloid solution is needed to restore plasma volume. Human Albumin is considered relevant in contexts involving heightened systemic burden.

The medication is generally applied in addressing the severe symptoms related to systemic imbalance, specifically hypovolemia (volume deficiency) and manifestations of shock, and is used to provide supportive assistance during episodes of plasma loss from severe burns or major trauma. It is also relevant for managing symptomatic fluid imbalances like refractory ascites and generalized edema in patients with conditions like advanced liver cirrhosis.

“This treatment supports circulatory stability during critical episodes and assists with managing the symptom burden of fluid accumulation.”

Quick Fact: Supportive Role in Circulatory Stress

Albunorm 20% contributes to easing signs of hemodynamic instability and supports the maintenance of blood flow to vital organs during periods of increased physiological stress.

Regulatory References

NIH DailyMed official prescribing information

Eligibility and Restrictions for Use

Who Can and Cannot Use Albunorm 20%?

This section describes the population eligibility rules for Albunorm 20% (Human Albumin 20%) as defined by official regulatory documentation.

Contraindicated Populations

Albunorm 20% must not be used by patients with a history of hypersensitivity (allergic reaction) to any albumin preparations or to any of the product’s excipients.

Populations and Conditions Requiring Restricted Use

Use of Albunorm 20% is subject to caution in specific populations where volume expansion poses a serious risk, often referred to as conditional eligibility. This includes patients with:

Decompensated cardiac insufficiency (severe heart failure).
Pulmonary oedema (fluid in the lungs).
Severe anaemia or haemorrhagic diathesis (bleeding tendency).
Conditions involving increased pressure, such as hypertension or oesophageal varices.

Additionally, use requires caution in patients with renal and post-renal anuria and is generally considered not justified for treating chronic hypoproteinaemia associated with liver cirrhosis or malabsorption.

Age-Related Eligibility and Life Stage

General Use: Albunorm 20% is approved for use in adults and certain pediatric patients (including children and newborns) for established indications.
Pregnancy and Lactation: The safety of use during pregnancy has not been established in controlled trials, meaning use is conditional on a clear medical need. Lactation (breastfeeding) is permitted as no harmful effects are known.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents establish the official interaction profile for Human Albumin primarily through its physical compatibility constraints rather than classical pharmacological interactions.

Pharmacological Interaction Profile

Official prescribing information from major regulatory authorities states that no specific interactions of Human Albumin with other medicinal products are formally known. This means the product is not documented to engage in common metabolic interactions, such as those mediated by CYP enzymes, nor are specific transporter-mediated or pharmacodynamic exposure-altering effects listed. The absence of such findings means the interaction profile is not defined by specific drug-drug combinations that alter drug concentration or plasma levels.

Administration-Related Restrictions

The core restrictions documented in regulatory labeling relate strictly to the administration procedure and physical compatibility of the solution. The product must not be mixed with protein hydrolysates, amino acid solutions, or other medicinal products in the same infusion container or line. This restriction is based on the risk of physical incompatibility, which could lead to precipitation or instability. Furthermore, the solution must not be diluted with sterile water for injection to prevent the risk of causing hemolysis in the recipient. This administration constraint also applies to mixing the product with whole blood, packed red cells, or solutions containing alcohol.

Mechanism of Action

Albunorm 20% (Human Albumin) acts based on the natural physiological functions of albumin, primarily across three key mechanistic domains in the blood plasma.

Fluid Regulation via Colloid Osmotic Pressure

This domain covers the drug's role in influencing fluid distribution through its unique physical properties. The high concentration of albumin in the plasma creates a strong oncotic gradient. This gradient physically draws water from the interstitial (extravascular) tissues back into the bloodstream, resulting in an increase in circulating plasma volume which influences systemic hemodynamic parameters.

Molecular Transport and Distribution Carrier

This domain describes the non-covalent binding capacity of the albumin molecule. It acts as the primary plasma carrier protein, engaging multiple binding sites to regulate the transport and distribution of numerous endogenous and waste products, including unconjugated bilirubin, hormones, and fatty acids, which facilitates the transport of ligands to metabolic or excretory sites.

Antioxidant and Redox Scavenging

This domain focuses on the chemical function of albumin. The Cysteine-34 residue on the protein is the biological target for reactive oxygen and nitrogen species, allowing albumin to act as a non-enzymatic antioxidant that scavenges harmful free radicals, which results in the scavenging of reactive species and chemical neutralization within the plasma.

Dosage and Administration Information

How to Use Albunorm 20%

Albunorm 20% is a highly concentrated Solution for Infusion that is administered exclusively by the Intravenous (IV) route. As a hyperoncotic (20%) solution, it is used in a carefully controlled environment, often a hospital or specialized clinic, due to the need for precise hemodynamic monitoring during administration.

Official Administration Guidelines

Administration of Albunorm 20% is governed by principles that prioritize individualized response over fixed schedules, while adhering to strict procedural requirements outlined in regulatory labeling.

Usage Constraint	Official Instruction (Label-Based)
Route & Form	Intravenous infusion only; must be used immediately after opening.
Dilution Rule	May be diluted in an isotonic solution (e.g., 0.9% sodium chloride), but must not be diluted with sterile water for injection.
Preparation	Solution should be visually inspected for clarity; if it is turbid, cloudy, or has deposits, it must be discarded.
Infusion Rate	Highly individualized; the rate is adjusted to the patient's specific circulatory condition.

Official Dosing Patterns

The dosage and infusion rate are determined by the adequacy of the patient's circulating blood volume and are continuously adjusted based on their clinical status. The fundamental limit on use is a maximum daily dose that should not exceed 2 g of albumin per kg of body weight.

Specific regimens exist for different conditions, such as an initial dose of 25 g for acute hypovolemia, which may be repeated after 15 to 30 minutes if needed. For pediatric use in hypovolemia, the typical range is 0.5 to 1 g/kg of body weight. The overall duration of use is generally short-term, tailored to the acute phase of fluid imbalance.

Recent Clinical Evidence

Evidence for Use in Restoring Blood Volume (Hypovolemia and Shock)

The core research on human albumin solutions, such as Albunorm 20%, was studied for their use as Colloid Plasma Expanders in critical care contexts. Large Randomized Controlled Trials (RCTs) and meta-analyses examined how albumin was used to manage measures of hemodynamic stability and volume expansion, alongside patient survival rates. When comparing albumin with crystalloids, research indicates patterns related to a generally similar overall survival rate. What remains uncertain is the full extent to which human albumin is associated with different outcomes compared to other volume-replacing fluids for the general critical care population.

Evidence for Use in Managing Fluid Shifts in Liver Disease

Research explores the use of albumin in managing conditions associated with acute fluid accumulation (ascites) in advanced liver disease. High-quality RCTs have studied its administration following large-volume fluid removal (paracentesis). Trials reported data show patterns related to a lower incidence of post-paracentesis circulatory dysfunction (PICD) in the group receiving human albumin compared to comparator groups. Other research explored outcomes related to systemic imbalance, such as renal function. The evidence is limited concerning the role of long-term or repeated administration for general fluid management.

Evidence for Use as Supportive Care in Severe Infection (Septic Shock)

The use of albumin was studied for its potential supportive role alongside standard care in severe infection leading to septic shock. Large multi-center RCTs explored whether the administration of albumin was associated with a difference in outcomes compared to standard care with crystalloids. Studies monitored endpoints like all-cause mortality and required life support measures. Findings for the overall septic population often reported similar mortality rates. Subgroup analyses reported observations suggesting a potential survival difference in the specific group of patients with confirmed septic shock.

Understanding Evidence Quality and Research Limitations

The overall evidence landscape for human albumin has been established through numerous studies, but the research quality varies across studies due to differences in patient severity and the comparison fluids used. The main limitations across the entire research body often relate to heterogeneity in the patient populations studied, meaning the results apply only to the populations studied. Most research focuses on short-term and intermediate-term outcomes. Data for certain groups remain limited, and specific studies have explored the administration of human albumin solutions in pediatric populations.

Key Studies & References

Human Albumin solution (ALBUMIN HUMAN) prescribing information (Regulatory Basis)

Frequently Asked Questions (FAQ)

Common questions about Albunorm 20% (FAQ)

Q: Why is this product sometimes used during surgery or medical procedures?

A: Albunorm 20% is an albumin solution. Official product information indicates that it is often used when a patient experiences a significant loss of circulating blood volume, such as during or after major surgery, severe burns, or trauma. Its primary function is to help restore and maintain the necessary volume of fluid circulating in the blood vessels.

Q: What is the source of the human albumin in Albunorm 20%?

A: According to regulatory sources, the active ingredient, human albumin, is derived from pooled plasma (the liquid component of blood) donated by human donors. All plasma donations undergo rigorous testing and extensive processing steps to support product quality and safety standards.

Q: What is the purpose of albumin in the human body?

A: Albumin is the most abundant protein found in human plasma (the liquid part of blood). Its main role is to maintain the osmotic pressure needed to keep fluid within the blood vessels, which is critical for proper circulation. Official documents state that Albunorm 20% is administered to restore this protein and the necessary volume in the body when levels are low.

Q: What should I do if I miss an appointment for my infusion?

A: Albunorm 20% is administered intravenously by a qualified healthcare professional, and the dosing is determined by your specific medical condition. If you miss a scheduled infusion appointment, contacting your treating physician or hospital is the appropriate next step for scheduling and guidance. Regulatory documents do not provide guidance for patient self-management of missed doses.

Q: Can I drive or operate machinery after receiving Albunorm 20%?

A: Official product information suggests that Albunorm 20% itself has no known direct influence on the ability to drive or use machines. However, the underlying medical condition for which you are being treated, or any potential side effects, could affect your abilities. It is recommended to discuss your ability to drive safely with your treating physician, considering your overall health status.

Q: How long can I expect to be in the hospital for this treatment?

A: Albunorm 20% is usually given in a clinical setting like a hospital or clinic under professional supervision. The overall length of your treatment and subsequent hospital stay depends entirely on your underlying medical condition and how your body responds to the therapy. The official product materials provide information on the drug but do not specify general hospital stay durations.

Q: What makes this product a 20% solution?

A: The '20%' designation refers to the concentration of the active ingredient, human albumin, in the solution. This means that for every 100 milliliters of the product, there are 20 grams of human albumin present. This concentration level is considered hyperoncotic, meaning it has a greater ability to draw fluid into the bloodstream from surrounding tissues compared to lower-concentration solutions.

Q: What should I tell my doctor before starting treatment with Albunorm 20%?

A: The official product information highlights the importance of providing your doctor with a complete medical history, including all of your medical conditions, known allergies, and current medications. It is particularly relevant to mention any existing history of heart failure, kidney problems, or if you are on a restricted sodium diet. Sharing a complete medical history allows your healthcare provider to assess the appropriate use and management of Albunorm 20% based on official guidelines.

How should Albunorm 20% be stored and disposed of?

Official Storage and Disposal Requirements

Storage and handling of Albunorm 20% must adhere strictly to official regulatory requirements to maintain product integrity.

Storage Condition	Requirement
Temperature	Do not store above +25 C or +30 C (check specific label). Do not freeze.
Light & Packaging	Keep the product in the original carton to protect from light.
Stability (After Opening)	Use the content immediately once the container is opened.
Visual Check	Do not use if the solution appears cloudy or contains deposits.

Handling and Disposal

Before use, if administering large volumes, the solution may be warmed to room or body temperature. Keep Albunorm 20% out of the sight and reach of children.

Any unused portion of the solution must be discarded. Do not dispose of this medicine via household waste or wastewater. For safe disposal, consult a pharmacist or follow local regulations designed to protect the environment.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.