Albumin Behring: Uses, Dosage & Side Effects
A concentrated 20% human albumin infusion solution used for plasma volume expansion and treatment of hypoalbuminemia in critically ill patients
Albumin Behring 200 g/l is a sterile, concentrated solution of human albumin designed for intravenous infusion. Manufactured by CSL Behring from carefully screened human plasma, this hyper-oncotic (20%) preparation belongs to the group of plasma substitutes and plasma protein fractions. It is administered exclusively in hospital settings by qualified healthcare professionals to restore and maintain circulating blood volume, correct hypoalbuminemia in critically ill patients, and manage conditions such as liver cirrhosis with ascites, nephrotic syndrome, and burn-related fluid losses. As a 20% solution, it provides potent volume expansion while requiring a significantly smaller infusion volume compared to iso-oncotic (5%) albumin preparations. Human albumin is listed on the WHO Model List of Essential Medicines and remains one of the most widely used plasma-derived products in intensive care and surgical medicine worldwide.
Quick Facts: Albumin Behring
Key Takeaways
- Albumin Behring is a concentrated 20% (200 g/l) human albumin solution that provides greater plasma volume expansion per milliliter than 5% albumin, making it ideal when fluid restriction is clinically necessary.
- It must be administered intravenously in a hospital setting by qualified healthcare professionals who continuously monitor blood pressure, heart rate, fluid balance, and laboratory values throughout the infusion.
- The hyper-oncotic nature of the 20% solution draws approximately 3.5 ml of interstitial fluid into the bloodstream for every 1 ml infused, so adequate patient hydration must be ensured to prevent dehydration.
- Albumin Behring must never be diluted with water for injection, as this can cause hemolysis (destruction of red blood cells) and potentially life-threatening complications.
- Patients with heart failure, hypertension, pulmonary edema, esophageal varices, severe anemia, or absent urine output require particularly careful monitoring and dosage adjustment during albumin infusion.
What Is Albumin Behring and What Is It Used For?
Albumin Behring 200 g/l contains human albumin, the most abundant protein in blood plasma, constituting approximately 60% of all plasma proteins. Albumin is naturally synthesized by the liver at a rate of approximately 12 to 25 grams per day in healthy adults and performs several essential physiological functions. It maintains colloid osmotic (oncotic) pressure, which keeps fluid within the blood vessels and prevents its leakage into surrounding tissues. It serves as a transport protein for hormones, enzymes, fatty acids, bilirubin, metal ions, and numerous medications. Additionally, albumin functions as a potent antioxidant and free radical scavenger, contributing to the body's defense against oxidative stress.
The product is manufactured by CSL Behring GmbH using the cold ethanol fractionation process (Cohn fractionation), a well-established method for purifying plasma proteins from pooled human plasma. The manufacturing process includes dedicated virus inactivation steps, notably pasteurization (heating in solution at 60°C for 10 hours), which provides an effective safeguard against enveloped and non-enveloped viruses. Donor plasma undergoes rigorous screening and testing before processing, including individual and pool testing for hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (anti-HCV), and HIV-1/HIV-2 antibodies, as well as nucleic acid amplification testing (NAT) for HBV, HCV, and HIV.
As a 20% (hyper-oncotic) albumin solution, Albumin Behring has a significantly higher oncotic pressure than normal plasma. This means that when infused intravenously, each milliliter of solution draws approximately 3.5 milliliters of interstitial fluid into the intravascular compartment through osmotic forces. This property makes the 20% formulation particularly advantageous in clinical situations where substantial plasma volume expansion is required but total fluid administration must be limited, such as in patients with pulmonary edema, heart failure, or severe generalized edema.
The half-life of circulating albumin in healthy individuals is approximately 19 days, with a daily turnover rate of about 5% of the total body albumin pool. In critically ill patients, however, the half-life may be significantly shortened due to increased capillary permeability, catabolism, and third-space fluid losses. This accelerated albumin turnover in severe illness is one of the key reasons why repeated albumin infusions may be necessary in intensive care settings.
Clinical Indications
Albumin Behring 200 g/l is indicated for the restoration and maintenance of circulating blood volume in clinical scenarios where volume replacement is necessary and a concentrated colloid solution is considered appropriate. The decision to use 20% albumin rather than a 5% solution, crystalloid fluid, or synthetic colloid is made by the treating physician based on the patient's overall clinical status, fluid balance requirements, and hemodynamic goals. The primary indications include:
- Hypovolemia: Acute reduction in circulating blood volume due to hemorrhage, trauma, major surgery, or extensive burns. In burn patients, albumin replacement is typically initiated after the first 24 hours when capillary permeability begins to normalize, as earlier administration may result in albumin leaking into the interstitial space.
- Hypoalbuminemia in critical illness: Critically ill patients frequently develop severe hypoalbuminemia (serum albumin below 20 g/l) due to increased capillary leak, reduced hepatic synthesis, catabolism, and dilution from crystalloid resuscitation. Concentrated albumin is used to restore oncotic pressure and improve fluid distribution between compartments.
- Liver cirrhosis with ascites: Patients with decompensated liver cirrhosis undergoing large-volume paracentesis (removal of ascitic fluid exceeding 5 liters) require albumin replacement to prevent post-paracentesis circulatory dysfunction (PPCD). International guidelines recommend 6 to 8 grams of albumin per liter of ascites removed. Albumin infusion is also used in the management of spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome.
- Nephrotic syndrome: Severe nephrotic syndrome with profound hypoalbuminemia and refractory edema unresponsive to diuretic therapy alone may benefit from albumin infusion combined with loop diuretics to enhance diuresis and reduce edema.
- Therapeutic plasma exchange (plasmapheresis): Albumin serves as the primary replacement fluid during therapeutic plasma exchange procedures, where patient plasma is removed and replaced with albumin solution to treat various autoimmune and hematological conditions.
- Cardiopulmonary bypass surgery: As a component of the bypass circuit priming solution and for post-operative volume management in cardiac surgery patients.
- Neonatal hyperbilirubinemia: In severe cases of newborn jaundice, albumin infusion may be used as an adjunct during exchange transfusion to enhance bilirubin binding capacity and facilitate its removal from the circulation.
Why 20% Instead of 5% Albumin?
The choice between 20% and 5% albumin depends on the clinical scenario and the patient's fluid status. The 20% solution (such as Albumin Behring 200 g/l) is hyper-oncotic, meaning it has a higher oncotic pressure than plasma. This makes it the preferred choice in situations where the clinical goal is to increase serum albumin concentration and expand plasma volume while minimizing the total volume of fluid administered. Conversely, the 5% (iso-oncotic) solution is preferred for straightforward volume replacement when fluid restriction is not a primary concern.
In practical terms, 100 ml of 20% albumin (containing 20 grams of albumin) provides approximately the same degree of plasma volume expansion as 400 ml of 5% albumin (containing 20 grams of albumin), but with significantly less total fluid administered. This distinction is clinically critical in patients who cannot tolerate additional fluid volume, such as those with congestive heart failure, pulmonary edema, or oliguric renal failure.
What Should You Know Before Receiving Albumin Behring?
Contraindications
The primary contraindication for Albumin Behring is a documented allergy (hypersensitivity) to human albumin preparations or to any of the excipients in the formulation. Allergic reactions to albumin products are rare but can be severe, including anaphylactic shock. If you have previously experienced an allergic or anaphylactic reaction to any human albumin product regardless of manufacturer, you must inform your healthcare team immediately, as the use of Albumin Behring would be contraindicated.
It is important to understand that while albumin is derived from human plasma through a standardized purification process, the specific excipients (stabilizers and other inactive ingredients) may vary between manufacturers. Patients who have had an adverse reaction to one albumin product may potentially tolerate a product from a different manufacturer, but this decision should only be made under close medical supervision with appropriate emergency preparedness. A complete allergy history should be documented before first administration.
Warnings and Precautions
If you experience any signs of an allergic or anaphylactic reaction during the infusion—including sudden difficulty breathing, facial swelling, widespread skin rash, flushing, rapid drop in blood pressure, or palpitations—inform your healthcare team immediately. The infusion must be stopped at once and emergency treatment must be initiated without delay.
Before initiating an infusion of Albumin Behring, your treating physician will conduct a thorough clinical assessment to determine whether albumin therapy is appropriate and safe for your specific condition. Several pre-existing conditions require heightened caution, dose modification, slower infusion rates, or more intensive monitoring during albumin administration. You should inform your physician if you have any of the following:
- Decompensated heart failure: The volume-expanding effect of hyper-oncotic albumin can significantly increase the circulating blood volume, potentially worsening cardiac function in patients with decompensated heart failure. The increased preload may precipitate acute pulmonary edema. The infusion rate must be carefully controlled, and the patient should be monitored for signs of cardiac decompensation.
- Hypertension (high blood pressure): The oncotic effect of concentrated albumin draws additional fluid into the vascular space, which may further elevate blood pressure in hypertensive patients. This can potentially lead to hypertensive emergencies including stroke, acute coronary events, or end-organ damage.
- Esophageal varices: Patients with portal hypertension and dilated esophageal veins face an increased risk of variceal hemorrhage when intravascular volume is rapidly expanded. This risk is particularly relevant in cirrhotic patients who paradoxically may also require albumin for other indications.
- Pulmonary edema: Adding volume to the circulation can exacerbate existing fluid accumulation in the lungs, leading to worsening respiratory function. Paradoxically, in some clinical scenarios, concentrated albumin may help mobilize interstitial fluid and improve pulmonary edema when used carefully with diuretics.
- Hemorrhagic diathesis: Patients with bleeding tendencies require careful volume management, as rapid volume expansion can dilute circulating coagulation factors and worsen coagulopathy. The dilutional effect of albumin infusion on platelets and clotting factors must be anticipated and managed.
- Severe anemia: Albumin does not carry oxygen and cannot substitute for red blood cell transfusion. In severely anemic patients, volume expansion with albumin may actually worsen oxygen delivery to tissues by further diluting the hemoglobin concentration.
- Renal anuria or oliguria: Patients with significantly reduced or absent urine production cannot excrete the additional fluid mobilized by hyper-oncotic albumin from the interstitial space, creating a substantial risk of severe fluid overload and pulmonary edema.
- Dehydration: Because 20% albumin is hyper-oncotic and draws fluid from the interstitial space into the blood vessels, administering it to a dehydrated patient can worsen tissue dehydration. Adequate hydration status must be established before or concurrently with the albumin infusion, either orally or by intravenous administration of crystalloid solutions.
When medicines are manufactured from human blood or plasma, comprehensive safety measures are implemented to prevent the transmission of infections to patients. These include rigorous screening and selection of blood and plasma donors, testing of individual donations and plasma pools for evidence of viruses and pathogens (including HBV, HCV, and HIV by both serological and NAT methods), and incorporation of validated virus inactivation and removal steps during manufacturing—notably pasteurization at 60°C for 10 hours for Albumin Behring. Despite these exhaustive measures, the possibility of transmitting known or unknown infectious agents cannot be entirely eliminated when administering any product derived from human blood or plasma. However, there are no documented reports of virus transmission with albumin manufactured in accordance with European Pharmacopoeia specifications and validated industrial processes.
For traceability purposes, it is strongly recommended that the product name and batch number of Albumin Behring be recorded each time the product is administered. This enables tracking of the specific product used in the unlikely event that a safety concern related to a particular batch is identified. Your healthcare facility will maintain these records as part of standard clinical practice and pharmacovigilance requirements.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, suspect that you may be pregnant, or are planning to become pregnant, inform your physician before receiving Albumin Behring. Human albumin is a naturally occurring protein in human blood, and no specific reproductive toxicity or teratogenic effects have been associated with its administration. The safety of human albumin in pregnancy has been established through decades of clinical use in obstetric emergencies, preeclampsia management, and critical care settings during pregnancy.
However, as with any blood-derived product, the decision to administer Albumin Behring during pregnancy or lactation must be made by the treating physician on the basis of individual clinical necessity. The physician will weigh the potential benefits of treatment against any theoretical risks in determining whether albumin therapy is appropriate for the specific clinical situation. Albumin is a normal component of breast milk, and no concerns have been raised regarding breastfeeding following albumin infusion.
Sodium Content
Albumin Behring 200 g/l contains a clinically significant amount of sodium (approximately 130 to 160 mmol/l). The actual sodium load delivered to the patient depends on the volume infused. For example, a 100 ml infusion delivers approximately 300 to 370 mg of sodium, while larger volumes proportionally increase the sodium load. This must be carefully considered for patients on sodium-restricted diets or those with conditions exacerbated by sodium intake, including heart failure, kidney disease, hypertension, and liver cirrhosis with ascites. Your physician will factor the sodium content into your overall fluid and electrolyte management plan.
How Does Albumin Behring Interact with Other Drugs?
Human albumin is an endogenous plasma protein that does not undergo hepatic metabolism through cytochrome P450 enzymes or other drug-metabolizing pathways that commonly mediate drug-drug interactions. Clinical experience spanning many decades has not identified specific harmful pharmacological interactions between albumin infusion products and other medications. However, several important considerations must be observed when albumin is administered alongside other treatments to ensure both safety and efficacy.
Compatibility Restrictions
Albumin solutions have strict compatibility requirements that must be rigorously observed during preparation and administration. Mixing albumin with incompatible substances can result in protein denaturation, precipitation, or loss of biological activity, potentially rendering the product ineffective or harmful. The following substances must never be mixed with Albumin Behring:
| Substance | Reason | Risk |
|---|---|---|
| Water for injection | Creates severely hypotonic solution | Hemolysis (destruction of red blood cells), potentially fatal |
| Whole blood or packed red blood cells | Incompatible protein-cell interactions | Protein aggregation and potential transfusion reaction |
| Protein hydrolysates (parenteral nutrition) | Chemical incompatibility with amino acids | Protein precipitation and loss of both products |
| Alcohol-containing solutions | Alcohol denatures albumin protein structure | Protein precipitation and loss of biological function |
| Other medications via same IV line | Variable and often untested compatibility | Potential precipitation, inactivation, or adverse reaction |
Protein Binding Considerations
Albumin is the most abundant drug-binding protein in blood plasma, responsible for binding and transporting a wide range of endogenous substances and exogenous drugs. When serum albumin levels change significantly—whether through disease processes that reduce albumin or through therapeutic albumin infusion that increases it—the free (pharmacologically active) fraction of highly protein-bound drugs may be altered. This effect is most clinically significant for drugs with narrow therapeutic indices that are extensively bound to albumin.
Drugs that are particularly susceptible to protein binding changes include warfarin (approximately 99% bound), phenytoin (approximately 90% bound), valproic acid (approximately 90% bound), diazepam (approximately 98% bound), and certain non-steroidal anti-inflammatory drugs. When albumin is infused in patients receiving these medications, the increased albumin concentration may transiently reduce the free drug fraction, potentially diminishing the therapeutic effect. Conversely, in patients with very low albumin levels, free drug concentrations may be unexpectedly high, increasing the risk of toxicity. Your clinical pharmacist and treating physician will monitor drug levels and therapeutic effects accordingly.
Coagulation Factor Dilution
When large volumes of albumin are administered, a dilutional effect on circulating coagulation factors, platelets, fibrinogen, and other blood components may occur. This dilutional coagulopathy can increase bleeding risk, particularly in patients who are already at risk due to surgical procedures, trauma, liver disease, or underlying coagulation disorders. The treating physician will monitor coagulation parameters (including prothrombin time, activated partial thromboplastin time, fibrinogen level, and platelet count) and ensure appropriate replacement of other blood components when significant albumin volumes are administered.
Electrolyte Effects
Albumin infusion can influence electrolyte balance through several mechanisms. The sodium content of the solution directly contributes to the patient's sodium load. Additionally, the oncotic effect of albumin may shift fluid between compartments, affecting the concentration of electrolytes in different body fluid spaces. Calcium binding to albumin is particularly important: albumin binds approximately 40% of total serum calcium, so changes in albumin concentration can affect both total and ionized calcium measurements. During therapeutic plasma exchange with albumin replacement, monitoring of ionized calcium is essential, as citrate anticoagulant used in the procedure can cause symptomatic hypocalcemia.
What Is the Correct Dosage of Albumin Behring?
Unlike many medications with predetermined dosing schedules, the administration of Albumin Behring 200 g/l is fully individualized. Your physician will determine the appropriate dose, concentration, infusion rate, and duration of treatment based on your specific clinical needs, ongoing assessment of your hemodynamic status, and response to therapy. Throughout the infusion and for a period afterward, your medical team will closely monitor multiple parameters including blood pressure, heart rate, central venous pressure (where applicable), respiratory rate and effort, oxygen saturation, urine output, and fluid balance. Laboratory monitoring will include serum albumin levels, electrolytes (particularly sodium, potassium, and calcium), hematocrit, hemoglobin, and coagulation parameters.
Adults
General Dosing Principles for Adults
The required dose of 20% albumin is determined by the patient's clinical situation, the degree of albumin deficit, and the treatment goals. Because the 20% solution is hyper-oncotic, adequate patient hydration must be ensured before and during infusion—either through oral fluid intake or concurrent intravenous crystalloid administration—to provide the water needed for the oncotic fluid shift. The maximum recommended infusion rate is 1 to 2 ml per minute for 20% albumin. Faster rates may be used in emergency situations with acute hemorrhage, but only under close hemodynamic monitoring.
Typical dose range: 50 ml to 200 ml (10 g to 40 g albumin) per infusion session, adjusted based on clinical response. The target is generally to maintain serum albumin above 25 g/l in critically ill patients, though the optimal target may vary based on the clinical context.
| Indication | Typical Dose | Monitoring |
|---|---|---|
| Hypovolemia (acute volume loss) | 50–200 ml (10–40 g), with concurrent crystalloid | Blood pressure, heart rate, CVP, urine output |
| Large-volume paracentesis (>5 L) | 6–8 g albumin per liter of ascites removed | Hemodynamic stability, renal function, sodium |
| Spontaneous bacterial peritonitis | 1.5 g/kg on day 1, 1 g/kg on day 3 | Renal function, serum albumin, infection markers |
| Burns (after first 24 hours) | Individualized based on burn extent and losses | Fluid balance, serum albumin, hematocrit, urine output |
| Therapeutic plasma exchange | Matched to plasma volume removed (typically 5% used) | Coagulation parameters, calcium, fibrinogen |
| Hypoalbuminemia in ICU | Target serum albumin >25 g/l; 100–200 ml per session | Serum albumin, fluid balance, electrolytes, COP |
Children
Pediatric Dosing
In children, the dose of albumin is calculated on a per-kilogram body weight basis and is determined entirely by the treating pediatrician or pediatric intensivist. Pediatric patients require particularly careful monitoring of fluid balance, electrolytes, and hemodynamic parameters during albumin infusion. The infusion rate must be adjusted to the child's size, weight, and cardiac capacity to avoid cardiovascular overload. Neonates and infants are especially vulnerable to fluid shifts and require meticulous volume calculations.
Typical pediatric dose: 0.5 to 1 g/kg body weight per infusion. For neonatal hyperbilirubinemia, albumin 1 g/kg may be administered 1 to 2 hours before exchange transfusion. The maximum daily dose is determined by the individual clinical situation and the child's tolerance.
Elderly Patients
Elderly patients frequently have reduced cardiac reserve, impaired renal function, and decreased physiological resilience, making them particularly susceptible to fluid overload during albumin infusion. No specific dose adjustment is formally defined for elderly patients, but the infusion rate should generally be slower (often 1 ml per minute or less) and monitoring should be more frequent and intensive. The treating physician will carefully assess the patient's cardiovascular status, renal function, and fluid balance before and throughout the infusion, adjusting the rate and total volume as needed to prevent circulatory overload. Special attention should be given to signs of pulmonary congestion, elevated jugular venous pressure, and peripheral edema.
Missed Dose
Albumin Behring is administered in a hospital setting by healthcare professionals, so the concept of a "missed dose" in the traditional sense does not apply. Treatment schedules are determined by the physician based on ongoing clinical assessment. If a planned albumin infusion is delayed or omitted, the treating physician will reassess the patient's clinical status and determine whether the infusion should be administered at a later time or whether the treatment plan should be modified.
Overdose
Hypervolemia (excessive blood volume) may occur if the dose or infusion rate is too high. At the first signs of cardiovascular overload—including headache, severe shortness of breath, jugular venous distension, increasing blood pressure, or crackles heard on lung auscultation—the infusion must be stopped immediately. Appropriate medical intervention should be initiated without delay. The risk of hypervolemia is particularly high with 20% albumin due to its potent oncotic effect.
If hypervolemia develops following albumin infusion, the standard clinical approach includes immediate cessation of the albumin infusion, elevation of the head of the bed to 30 to 45 degrees to reduce pulmonary congestion, administration of intravenous diuretics (typically furosemide) to promote diuresis and reduce intravascular volume, oxygen supplementation as needed, and continuous hemodynamic monitoring. In severe cases with respiratory failure, non-invasive or invasive mechanical ventilation may be required. There is no specific antidote for albumin overdose; management is entirely supportive and focused on treating the hemodynamic consequences of volume overload.
What Are the Side Effects of Albumin Behring?
Like all medicines, Albumin Behring can cause side effects, although not everyone who receives it will experience them. The majority of patients tolerate albumin infusions well when they are administered at the appropriate rate under proper medical supervision with adequate monitoring. However, as with any blood-derived product, hypersensitivity reactions can occur and require immediate recognition and treatment. The risk of adverse reactions may be increased when the infusion rate is too rapid, when the patient is inadequately hydrated, or when the patient has pre-existing conditions that compromise cardiovascular or respiratory function.
If you experience any symptoms such as difficulty breathing, facial or throat swelling, widespread rash, rapid drop in blood pressure, dizziness, chest tightness, or palpitations during or after an albumin infusion, alert your healthcare team immediately. The infusion will be stopped and appropriate emergency treatment will be provided promptly.
Very Rare
May affect up to 1 in 10,000 patients
- Anaphylactic shock (a severe, life-threatening allergic reaction causing cardiovascular collapse, requiring immediate epinephrine and emergency resuscitation)
Rare
May affect up to 1 in 1,000 patients
- Nausea (feeling sick to the stomach)
- Flushing (redness of the face and upper body)
- Skin rash (erythematous or maculopapular eruption)
- Fever (elevated body temperature during or after infusion)
Frequency Not Known
Cannot be estimated from available data
- Headache (ranging from mild to severe)
- Dysgeusia (altered or metallic taste perception)
- Confusional state (disorientation or mental confusion)
- Myocardial infarction (heart attack)
- Cardiac arrhythmias (irregular heartbeat, atrial fibrillation)
- Tachycardia (rapid heartbeat exceeding 100 beats per minute)
- Bradycardia (abnormally slow heart rate)
- Hypotension (abnormally low blood pressure, potentially with syncope)
- Hypertension (elevated blood pressure)
- Pulmonary edema (fluid accumulation in the lungs causing respiratory distress)
- Dyspnea (shortness of breath or difficulty breathing)
- Bronchospasm (airway constriction with wheezing)
- Vomiting
- Urticaria (hives with raised, itchy welts)
- Angioedema (deep swelling of the skin, particularly face and throat)
- Pruritus (generalized itching)
- Erythema (skin redness)
- Hyperhidrosis (excessive sweating)
- Chills and rigors (shaking chills)
- Pyrexia (fever)
When to Seek Immediate Medical Attention
Because Albumin Behring is administered in a hospital setting, your healthcare team will be monitoring you throughout the infusion and for a period afterward. However, it is essential that you communicate any unusual sensations, discomfort, or changes in how you feel immediately. The following symptoms require urgent medical assessment and may necessitate stopping the infusion:
- Sudden difficulty breathing, wheezing, or sensation of throat tightness
- Swelling of the face, lips, tongue, or throat (angioedema)
- Severe or widespread skin rash, hives, or intense itching
- Feeling faint, dizzy, lightheaded, or experiencing tunnel vision
- Rapid, irregular, or pounding heartbeat
- Chest pain, chest tightness, or feeling of pressure
- Severe headache developing during or shortly after the infusion
- Significantly reduced or absent urine output
- Sudden onset of confusion or disorientation
- Severe back pain during infusion (may indicate hemolytic reaction if product is contaminated)
Reporting Side Effects
Reporting suspected side effects after a medicine has been authorized is critically important for the ongoing monitoring of its benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority. In Europe, reports can be made to the European Medicines Agency (EMA) or national competent authorities. In the United States, the FDA MedWatch program accepts voluntary reports. In the United Kingdom, the MHRA Yellow Card Scheme is the designated reporting mechanism. Your healthcare provider can assist you with the reporting process.
How Should You Store Albumin Behring?
Proper storage of Albumin Behring is essential to maintain the quality, safety, and efficacy of the product. In hospital settings, the pharmacy department is responsible for ensuring correct storage conditions throughout the product's shelf life. Understanding these requirements helps ensure appropriate handling at all stages. The following storage guidelines must be observed:
- Temperature: Store at or below 25°C (77°F). The product should be maintained at a consistent temperature within this range. Sustained exposure to temperatures above 25°C can accelerate protein degradation, reduce product potency, and potentially compromise patient safety. Brief temperature excursions during transport may be acceptable within defined limits, but the product should be returned to proper storage conditions as soon as possible.
- Freezing: Albumin Behring must not be frozen under any circumstances. Freezing causes irreversible changes to the albumin protein structure (denaturation and aggregation), rendering the product unsafe for intravenous use. Frozen and subsequently thawed albumin may contain protein aggregates that can cause serious adverse reactions including anaphylaxis if administered.
- Light protection: Keep the vial in its outer carton at all times when not in use, to protect the solution from light exposure. Prolonged exposure to light, particularly ultraviolet light, can accelerate photo-oxidation of the albumin protein and degradation of stabilizers.
- After opening: Once the vial has been opened (punctured), the contents should be used immediately. Any unused solution remaining in the vial after the infusion must be discarded according to institutional protocols for biohazardous waste. The product does not contain bacteriostatic preservatives, so there is a significant risk of microbial contamination and bacterial growth if the opened vial is stored, even briefly.
- Expiry date: Always check the expiry date printed on both the label and outer carton before use. The expiry date refers to the last day of the month indicated. Do not use the product after this date, as the quality and safety of the albumin can no longer be guaranteed.
- Visual inspection: Before administration, visually inspect the solution through the transparent portions of the container. Albumin Behring 200 g/l should appear as a clear, slightly viscous liquid that may range in color from nearly colorless to pale yellow, amber, or green. These color variations are normal and do not affect product quality. Do not use the solution if it appears turbid (cloudy), contains visible particulate matter, precipitate, or sediment, or if the container seal appears damaged or compromised.
Keep all medicines out of the sight and reach of children. Although Albumin Behring is a hospital-administered product, standard pharmaceutical storage precautions apply within healthcare facilities, particularly in areas accessible to non-clinical staff or visitors.
What Does Albumin Behring Contain?
Active Ingredient
The active substance in Albumin Behring 200 g/l is human albumin. Each 100 ml of solution contains 20 grams of total protein, of which at least 95% is human albumin as determined by electrophoretic analysis. The albumin is derived from pooled human plasma collected from carefully screened voluntary blood donors and processed through the cold ethanol fractionation (Cohn) method with subsequent purification steps. The manufacturing process includes pasteurization (heating at 60°C for 10 hours in liquid state) as a validated virus inactivation step.
Albumin is the most abundant protein in human plasma, normally present at concentrations of 35 to 50 g/l in healthy adults. Structurally, it is a single-chain polypeptide composed of 585 amino acid residues with a molecular weight of approximately 66,500 daltons (66.5 kDa). The protein has a heart-shaped three-dimensional structure with multiple binding sites for endogenous and exogenous ligands. It is highly water-soluble, negatively charged at physiological pH, and is the primary determinant of plasma oncotic pressure, accounting for approximately 80% of the total colloid osmotic pressure of blood.
At the 20% concentration, Albumin Behring has an oncotic pressure approximately four times that of normal plasma (approximately 100 mmHg compared to 25 mmHg for plasma), which explains its potent ability to draw fluid from the interstitial space into the intravascular compartment. This hyper-oncotic property is the fundamental pharmacological basis for its use in clinical conditions requiring concentrated volume expansion.
Inactive Ingredients (Excipients)
| Excipient | Function |
|---|---|
| Sodium chloride | Maintains isotonicity and provides electrolyte balance; contributes to the sodium content of the solution |
| Sodium caprylate (sodium octanoate) | Stabilizer that protects the albumin protein from thermal denaturation during the pasteurization step (60°C for 10 hours) |
| Sodium acetyltryptophan (N-acetyl-DL-tryptophan) | Stabilizer that protects albumin from oxidative damage and thermal denaturation; works synergistically with sodium caprylate |
| Water for injection | Pharmaceutical-grade solvent (vehicle) meeting European Pharmacopoeia standards |
Packaging
Albumin Behring 200 g/l is supplied in sealed glass vials as a sterile, clear, slightly viscous solution. The color may range from nearly colorless to pale yellow, amber, or green—these color variations are normal and reflect natural differences in the source plasma and do not affect the quality, safety, or efficacy of the product. The solution is provided as a single-use preparation; any unused portion must be discarded after the vial has been opened.
The total sodium ion content of the solution is approximately 130 to 160 mmol/l. The solution has an osmolality of approximately 100 mOsmol/kg (when considering protein as an osmolyte, the effective osmolality is higher due to the Gibbs-Donnan effect). The pH of the solution is adjusted to the physiological range of 6.7 to 7.3. All packaging materials are in compliance with European Pharmacopoeia requirements for containers for human blood products.
What Should Healthcare Professionals Know About Administering Albumin Behring?
The following information is intended for healthcare professionals involved in the prescribing, preparation, and administration of Albumin Behring 200 g/l. Adherence to proper technique and these clinical guidelines is essential for patient safety, product efficacy, and regulatory compliance.
Preparation and Administration
- Route: Albumin Behring 200 g/l is administered exclusively by the intravenous route using a sterile, pyrogen-free, single-use infusion set with an appropriate filter.
- Dilution: The product must never be diluted with water for injection, as this creates a hypotonic solution that can cause hemolysis. If dilution is clinically indicated (e.g., to adjust the infusion rate or concentration), only appropriate isotonic solutions such as 0.9% sodium chloride or 5% glucose should be used.
- Hydration: Because the 20% solution is hyper-oncotic, ensure the patient is adequately hydrated before initiating the infusion. Concurrent administration of crystalloid may be necessary to provide the water required for the oncotic fluid shift from the interstitial to the intravascular space.
- Integrity check: Before use, verify that the vial seal is intact and that the closure system has not been tampered with. Discard the product if the seal is compromised or if there is any evidence of leakage.
- Visual inspection: Inspect the solution for clarity. The product should appear as a clear, slightly viscous liquid ranging from nearly colorless to pale yellow, amber, or green. Do not use solutions that are turbid, contain particulate matter, or show signs of precipitation.
- Infusion rate: The maximum recommended rate for 20% albumin is 1 to 2 ml per minute in hemodynamically stable patients. In acute emergency situations involving hemorrhage or severe hypovolemia, faster rates may be used under intensive monitoring. In elderly patients or those with cardiac compromise, slower rates (0.5 to 1 ml per minute) are advisable.
- Temperature: Bring the product to room temperature before administration to improve patient comfort and reduce the theoretical risk of infusion-related reactions. Do not use external heat sources (such as microwaves) to warm the product.
- Single use: Commence the infusion immediately after connecting the infusion set. The entire contents should be used within a single session. Discard any unused solution.
Monitoring Requirements
Patients receiving Albumin Behring infusion require close and frequent monitoring of the following parameters:
- Blood pressure, heart rate, and respiratory rate at baseline and at regular intervals (at least every 15 minutes during infusion)
- Central venous pressure (CVP) where available, particularly in critically ill patients and those at risk of volume overload
- Pulse oximetry for continuous oxygen saturation monitoring
- Urine output to assess renal perfusion and guide fluid management
- Serum albumin, total protein, electrolytes (sodium, potassium, chloride, ionized calcium), hematocrit, hemoglobin, and coagulation parameters
- Lung auscultation for development of crackles or wheezes suggestive of pulmonary congestion
- Signs and symptoms of allergic or anaphylactic reactions, especially during the first 15 to 30 minutes of infusion when the risk is highest
Appropriate replacement of other blood components—including coagulation factors, electrolytes, platelets, and red blood cells—must be ensured when significant volumes of albumin are administered. For batch traceability and pharmacovigilance purposes, the product name and batch number must be documented in the patient's medical record each time Albumin Behring is administered.
Frequently Asked Questions About Albumin Behring
Albumin Behring is a concentrated 20% human albumin solution used in hospital settings to restore and maintain circulating blood volume in patients who have lost blood and fluid. It is indicated for hypovolemia due to trauma, surgery, or burns; hypoalbuminemia in critically ill patients; liver cirrhosis with ascites (particularly during large-volume paracentesis and spontaneous bacterial peritonitis); nephrotic syndrome with refractory edema; therapeutic plasma exchange; and cardiopulmonary bypass surgery. Its hyper-oncotic nature makes it particularly useful when fluid restriction is necessary.
Albumin Behring 200 g/l is a 20% (hyper-oncotic) solution, containing four times the albumin concentration of a 5% (iso-oncotic) solution. The 20% solution draws fluid from the interstitial space into the bloodstream—approximately 3.5 ml per 1 ml infused—providing substantial volume expansion with less total fluid administered. The 5% solution has an oncotic pressure similar to normal plasma and provides volume-for-volume expansion. In practice, 100 ml of 20% albumin provides similar volume expansion to 400 ml of 5% albumin. The 20% formulation is preferred when fluid restriction is necessary (heart failure, pulmonary edema, or severe hypoalbuminemia), while the 5% solution is better suited for straightforward volume replacement.
When medicines are made from human blood or plasma, comprehensive safety measures are taken to prevent infection transmission. For Albumin Behring, these include rigorous donor screening and selection, serological and nucleic acid testing (NAT) of individual donations and plasma pools for HBV, HCV, and HIV, and validated virus inactivation through pasteurization (heating at 60°C for 10 hours in liquid state). While the theoretical risk of transmitting any known or unknown infectious agent cannot be entirely eliminated, there are no documented reports of virus transmission with albumin manufactured according to European Pharmacopoeia specifications. The safety record of pasteurized human albumin products is excellent over decades of clinical use.
Human albumin is a naturally occurring protein in the body, and no specific teratogenic or reproductive toxicity concerns have been identified. Human albumin products have been used safely in obstetric emergencies, preeclampsia management, and critical care settings during pregnancy for decades. However, as with all blood-derived products, the decision to use Albumin Behring during pregnancy or breastfeeding should be made by a physician who weighs the clinical benefits against any theoretical risks. Albumin is a normal component of breast milk, and no concerns have been raised regarding breastfeeding after albumin infusion.
The duration of an Albumin Behring infusion depends on the dose administered, the clinical indication, and the patient's tolerance. For 20% albumin, the recommended maximum infusion rate is 1 to 2 ml per minute. A typical 100 ml infusion would therefore take 50 to 100 minutes at this maximum rate. In practice, slower rates are often used, particularly in elderly patients, those with cardiac compromise, or when larger volumes are administered. In emergency situations involving acute hemorrhage, faster rates may be used under intensive monitoring. Your healthcare team will determine the optimal rate based on your individual clinical situation and ongoing response to the infusion.
Albumin Behring should be stored at or below 25°C (77°F) and must never be frozen. The vial should be kept in its outer carton to protect from light. Once the vial has been opened, the entire contents should be used immediately for the current infusion session. Any remaining unused solution must be discarded, as the product does not contain preservatives and is susceptible to microbial contamination. Do not use the product if it appears cloudy, contains visible particles, or if the expiry date has passed.
References
This article is based on the following peer-reviewed sources and authoritative medical guidelines:
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization; 2023. Human albumin is listed as an essential medicine for plasma volume expansion and other clinical indications.
- European Medicines Agency (EMA). Human Albumin Solution – Summary of Product Characteristics. Amsterdam: European Medicines Agency; 2024. Comprehensive prescribing information for human albumin products authorized in the European Union.
- U.S. Food and Drug Administration (FDA). Albumin (Human) 25% Prescribing Information. Silver Spring, MD: FDA; 2023. Regulatory labeling information for concentrated human albumin products approved for use in the United States.
- British National Formulary (BNF). Human Albumin Solution Monograph. London: BMJ Group and Pharmaceutical Press; 2024. Clinical guidance on indications, dosing, and monitoring for human albumin in UK practice.
- Cochrane Database of Systematic Reviews. Human albumin administration in critically ill patients: systematic review of randomised controlled trials. Cochrane Library; 2024. Systematic analysis of evidence for albumin use in critical care settings.
- European Association for the Study of the Liver (EASL). Clinical Practice Guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. Journal of Hepatology. 2024;72(2):275–286. doi:10.1016/j.jhep.2018.03.024.
- SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. New England Journal of Medicine. 2004;350(22):2247–2256. doi:10.1056/NEJMoa040232.
- Bernardi M, Caraceni P, Navickis RJ, Wilkes MM. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology. 2012;55(4):1172–1181. doi:10.1002/hep.24786.
- Melia D, Post B. Human albumin solutions in intensive care: a review. Journal of Intensive Care Society. 2021;22(3):248–254. doi:10.1177/1751143720961245.
- European Pharmacopoeia. Human Albumin Solution – Monograph. Council of Europe; 2024. Quality specifications and manufacturing standards for human albumin products used in clinical medicine.
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