Crealb (Human Albumin 200 g/L)
Concentrated human albumin solution for intravenous infusion
Quick Facts about Crealb
Key Takeaways About Crealb
- Concentrated albumin solution: Crealb contains 200 g/L human albumin, a hyperoncotic formulation that draws fluid from tissues into the bloodstream
- Hospital-only medication: Must be administered intravenously under medical supervision in a hospital or clinical setting
- Multiple clinical uses: Used for hypovolaemia, hypoalbuminaemia, liver cirrhosis with ascites, severe burns, and therapeutic plasma exchange
- Plasma-derived product: Manufactured from pooled human plasma with rigorous viral safety measures including pasteurisation and nanofiltration
- Careful monitoring required: Infusion rate and dosage must be individualised to prevent hypervolaemia (fluid overload) and cardiovascular complications
What Is Crealb and What Is It Used For?
Crealb is a sterile, concentrated solution of human albumin (200 g/L) for intravenous infusion. It belongs to the class of plasma protein fractions and is used to restore and maintain circulating blood volume in patients with documented volume deficiency. Albumin is the most abundant protein in human blood plasma, accounting for approximately 50-60% of total plasma proteins.
Human albumin is a naturally occurring protein synthesised by the liver. It plays a critical role in maintaining the oncotic pressure of blood, which is the osmotic force that keeps fluid within the blood vessels. When albumin levels fall or when blood volume is depleted, fluid can leak from blood vessels into surrounding tissues, causing oedema and impairing organ function. Crealb provides exogenous albumin to correct these deficiencies.
Crealb is a hyperoncotic solution, meaning it has a higher osmotic pressure than normal blood plasma. When infused intravenously, it draws water from the interstitial space (the area between cells) into the intravascular compartment (the bloodstream). This effect makes it particularly useful for patients who have both low albumin levels and excess fluid in their tissues, such as those with liver cirrhosis and ascites.
The product is manufactured from pooled human plasma donations. During manufacturing, the plasma undergoes multiple viral inactivation and removal steps, including pasteurisation (heating at 60°C for 10 hours) and nanofiltration, to minimise the risk of transmitting infectious agents. Despite these measures, the theoretical risk of transmitting known or unknown pathogens cannot be completely eliminated, although no cases of viral transmission have been documented with modern albumin products meeting European Pharmacopoeia standards.
Approved Indications
Crealb is indicated for the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and where the use of a colloid is considered appropriate. Specific clinical situations include:
- Hypovolaemia: Restoration of blood volume following acute blood loss, trauma, or surgical procedures when crystalloids alone are insufficient
- Hypoalbuminaemia: Correction of low serum albumin levels caused by impaired synthesis (e.g., liver failure) or increased loss (e.g., nephrotic syndrome, burns)
- Liver cirrhosis with ascites: Management of ascites through large-volume paracentesis, where albumin infusion helps prevent circulatory dysfunction
- Severe burns: Volume replacement in the first 24 hours and beyond, particularly when capillary permeability begins to normalise
- Nephrotic syndrome: Short-term management of severe oedema unresponsive to diuretics, in combination with diuretic therapy
- Therapeutic plasma exchange: Used as replacement fluid during therapeutic plasmapheresis procedures
- Neonatal hyperbilirubinaemia: Adjunct to exchange transfusion in severe neonatal jaundice
The decision to use albumin rather than an artificial colloid or crystalloid should be based on current clinical guidelines and the patient's individual clinical condition. In many situations, crystalloid solutions may be equally effective and more cost-effective. International guidelines, including those from the Surviving Sepsis Campaign, recommend crystalloids as first-line fluid therapy in most critically ill patients.
What Should You Know Before Taking Crealb?
Crealb is a prescription-only medicine administered exclusively by healthcare professionals. Before receiving Crealb, your medical team will assess your cardiovascular status, hydration level, and kidney function. Certain conditions require special caution or may preclude the use of concentrated albumin solutions.
Contraindications
Crealb should not be administered to patients with a known hypersensitivity to human albumin preparations or to any of the excipients in the formulation. Although rare, allergic reactions to albumin have been documented, and patients with a history of such reactions should not receive the product.
There are no absolute contraindications to albumin administration other than known hypersensitivity. However, the concentrated 200 g/L formulation requires special consideration because of its hyperoncotic properties. It should be used with extreme caution in the following situations:
- Decompensated cardiac insufficiency: The volume-expanding effect may worsen heart failure
- Severe hypertension: Risk of acute blood pressure elevation
- Oesophageal varices: Volume expansion may increase portal pressure
- Pulmonary oedema: Risk of worsening respiratory function
- Severe anaemia: Volume expansion without red blood cells may dilute oxygen-carrying capacity
- Renal anuria: Inability to excrete excess fluid
Warnings and Precautions
Hypervolaemia (fluid overload) is the most significant risk associated with concentrated albumin solutions. Because Crealb 200 g/L is hyperoncotic, it draws additional fluid from the interstitial space into the bloodstream. If the infusion rate is too high or the total volume administered is excessive relative to the patient's circulatory capacity, hypervolaemia can develop, potentially leading to pulmonary oedema and cardiovascular collapse.
Healthcare professionals should monitor the following parameters during and after albumin infusion:
- Blood pressure and heart rate
- Central venous pressure (where available)
- Urine output
- Electrolyte levels, particularly sodium
- Haematocrit and haemoglobin levels
- Signs and symptoms of fluid overload (dyspnoea, jugular venous distension, peripheral oedema)
Allergic or anaphylactoid reactions are possible with any human plasma-derived product. If signs of an allergic reaction occur (fever, chills, urticaria, flushing, hypotension, tachycardia, dyspnoea), the infusion must be stopped immediately and appropriate treatment initiated. In cases of severe anaphylactic shock, standard emergency treatment protocols should be followed.
As a product derived from human blood, Crealb carries a theoretical risk of transmitting infectious agents, including viruses and, theoretically, the agent responsible for variant Creutzfeldt-Jakob disease (vCJD). However, the manufacturing process includes effective viral inactivation steps, and no cases of viral transmission have been confirmed with licensed albumin products manufactured according to current European Pharmacopoeia standards.
Pregnancy and Breastfeeding
Human albumin is a normal constituent of human blood plasma and is not expected to cause harm during pregnancy or breastfeeding. No controlled clinical studies have been conducted with Crealb in pregnant women. However, extensive clinical experience over decades suggests that albumin does not have harmful effects on the course of pregnancy, the foetus, or the neonate when used at recommended doses.
Albumin solutions have been used during pregnancy for conditions such as pre-eclampsia, HELLP syndrome, and severe hypoalbuminaemia. The decision to use Crealb during pregnancy should be made by the treating physician, weighing the clinical need against the theoretical risks. Crealb is compatible with breastfeeding, as albumin is a natural component of breast milk.
How Does Crealb Interact with Other Drugs?
No specific drug interactions have been established with human albumin solutions based on formal interaction studies. However, certain medications may require dose adjustments when administered concurrently with albumin infusions due to changes in plasma protein binding, dilution effects, or physiological responses to volume expansion.
Albumin is a major binding protein for many drugs in the blood. When serum albumin levels change significantly — either increasing (through albumin infusion) or decreasing (in disease states) — the free fraction of protein-bound drugs may be altered. This can potentially affect the pharmacological activity and clearance of highly protein-bound medications.
In practice, clinically significant interactions are uncommon because the body has multiple compensatory mechanisms to regulate drug distribution and elimination. However, healthcare professionals should be aware of the following considerations:
| Drug / Drug Class | Type of Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| ACE Inhibitors (e.g., enalapril, ramipril) | Increased risk of anaphylactoid reactions | Moderate | Monitor closely; consider temporary discontinuation |
| Highly protein-bound drugs (e.g., warfarin, phenytoin, diazepam) | Altered free drug fraction due to binding competition | Low to Moderate | Monitor drug levels where applicable |
| Diuretics (e.g., furosemide) | Synergistic effect on fluid redistribution | Therapeutic | Often used intentionally together; monitor fluid balance |
| Calcium-containing solutions | Potential incompatibility if mixed | High (if co-administered in same line) | Do not mix; use separate infusion lines |
| Blood products (whole blood, packed red cells) | No pharmacological interaction | Low | Can be administered sequentially; do not mix |
Compatibility and Administration
Crealb should not be mixed with other medicinal products, whole blood, or packed red blood cells in the same infusion set or container. Albumin solutions may be diluted with isotonic solutions such as 0.9% sodium chloride (normal saline) or 5% glucose, but should not be diluted with water for injection, as this can cause haemolysis in the recipient. The solution should be inspected visually before use; it should be clear and slightly viscous. Do not use if the solution is turbid or contains particles.
What Is the Correct Dosage of Crealb?
The dose of Crealb is individualised based on the patient's clinical condition, body weight, degree of volume deficit, and ongoing fluid losses. There is no single standard dose; the prescribing physician determines the appropriate regimen based on haemodynamic monitoring and clinical response. Typical doses range from 25 g to 75 g of albumin per administration for adults.
Because Crealb is a concentrated 200 g/L (20%) albumin solution, relatively small volumes deliver significant amounts of protein. For example, 100 mL of Crealb contains 20 g of human albumin. The hyperoncotic nature of this solution means that the effective volume expansion is greater than the volume infused, as it mobilises additional fluid from the interstitial space.
| Indication | Typical Dose | Infusion Rate | Notes |
|---|---|---|---|
| Hypovolaemia (acute) | 25–75 g (125–375 mL) | 1–2 mL/min initially | Adjust rate based on blood pressure response; faster rates permissible in haemorrhagic shock |
| Large-volume paracentesis | 6–8 g per litre of ascites removed | As tolerated | Administer after paracentesis to prevent post-paracentesis circulatory dysfunction |
| Nephrotic syndrome | 25 g (125 mL) with diuretic | 1–2 mL/min | Typically combined with loop diuretics; short-term use only |
| Severe burns | Individualised; guided by albumin levels | Slow infusion | Primarily after 24 hours post-burn; target serum albumin >20 g/L |
| Therapeutic plasma exchange | Volume-for-volume replacement | Per procedure protocol | Often diluted to 5% with saline before use |
Adults
In adult patients, the required dose depends on the size of the patient, the severity of the clinical condition, and the extent of ongoing fluid or protein losses. A common approach is to target a serum albumin level above 25 g/L or a total plasma protein concentration above 52 g/L. However, the albumin level itself is not always the best guide to dosing; haemodynamic parameters such as blood pressure, heart rate, and urine output are often more clinically relevant.
For volume resuscitation in hypovolaemia, an initial dose of 25 g (125 mL of Crealb 200 g/L) may be administered, with further doses titrated to clinical response. The maximum infusion rate should generally not exceed 1–2 mL per minute to avoid rapid volume expansion and its complications. In haemorrhagic shock, faster infusion rates may be acceptable under close monitoring.
Children
In paediatric patients, the dose of albumin is typically calculated based on body weight: 0.5–1 g/kg per dose (equivalent to 2.5–5 mL/kg of Crealb 200 g/L). The infusion rate should be slower than in adults, generally not exceeding 0.5–1 mL per minute, and the child must be closely monitored for signs of fluid overload. Neonates and infants are particularly susceptible to hypervolaemia due to their relatively small circulating blood volume.
Elderly
Elderly patients may have reduced cardiac reserve and renal function, increasing their susceptibility to hypervolaemia. The dose and infusion rate should be at the lower end of the recommended range, with particularly careful haemodynamic monitoring. Renal function should be assessed before and during treatment, and electrolyte levels should be monitored closely.
Missed Dose
Because Crealb is administered in a hospital setting by healthcare professionals, missed doses are managed by the clinical team. If a scheduled albumin infusion is delayed or omitted, the treating physician will determine whether it should be administered as soon as possible or whether the treatment plan should be adjusted based on the patient's current clinical status.
Overdose
Overdose with hyperoncotic albumin solution can lead to hypervolaemia, which may manifest as dyspnoea, jugular venous distension, increased blood pressure, pulmonary oedema, and peripheral oedema. In severe cases, cardiac failure and respiratory failure may develop. Treatment of hypervolaemia includes immediate cessation of the albumin infusion, administration of diuretics, and supportive care. In extreme cases, phlebotomy or ultrafiltration may be necessary.
Hypervolaemia is a potentially life-threatening complication of albumin infusion, particularly with the concentrated 200 g/L formulation. The infusion rate must be carefully controlled, and patients must be monitored continuously for signs of circulatory overload. Elderly patients and those with cardiac or renal impairment are at highest risk.
What Are the Side Effects of Crealb?
Side effects from human albumin infusions are generally uncommon. Mild reactions such as flushing, urticaria, and fever occur infrequently. Serious allergic or anaphylactoid reactions are rare but can be life-threatening. The most clinically important adverse effect is hypervolaemia (fluid overload), which is related to the dose and infusion rate rather than being an inherent property of the drug.
Human albumin has an excellent safety profile that has been well documented over decades of clinical use. The following side effects have been reported with albumin solutions. Their frequency is classified according to the standard MedDRA convention used by the European Medicines Agency (EMA).
Uncommon (1/100 to 1/1,000)
- Flushing
- Urticaria (hives)
- Fever (pyrexia)
- Nausea
- Headache
Rare (1/1,000 to 1/10,000)
- Hypotension (low blood pressure)
- Tachycardia (rapid heart rate)
- Chills and rigors
- Vomiting
- Dyspnoea (shortness of breath)
- Anaphylactoid reactions
- Anaphylactic shock
In addition to the classified adverse reactions above, the following effects may occur as a consequence of the albumin infusion rather than as direct side effects of the protein itself:
- Hypervolaemia: Fluid overload due to excessive dosing or rapid infusion rate, manifesting as pulmonary oedema, peripheral oedema, and elevated blood pressure
- Dilutional coagulopathy: Large volumes of albumin can dilute coagulation factors, potentially impairing blood clotting
- Electrolyte disturbances: Particularly hyponatraemia or hyperkalaemia, depending on the electrolyte composition of the product and concurrent fluid therapy
- Haemodilution: Reduction in haematocrit and haemoglobin concentration due to plasma volume expansion
If any adverse reaction occurs during the infusion, the infusion rate should be slowed or the infusion should be stopped entirely. For mild allergic reactions (e.g., urticaria, flushing), antihistamines may be administered and the infusion may be resumed at a slower rate after symptoms resolve. For severe reactions (anaphylaxis, severe hypotension), the infusion must be stopped immediately and standard emergency treatment initiated, including epinephrine, corticosteroids, and supportive care.
If you experience any side effects during or after receiving Crealb, inform your healthcare team immediately. Healthcare professionals are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority (e.g., the EMA in the EU, the FDA in the US, or the MHRA in the UK).
How Should You Store Crealb?
Crealb should be stored at temperatures not exceeding 25°C. It must not be frozen. The product should be kept in its original packaging to protect it from light. After opening, the solution should be used immediately. Any unused portion must be discarded.
As a biological product derived from human plasma, Crealb has specific storage requirements to maintain its stability and safety:
- Temperature: Store below 25°C (77°F). Do not freeze. Freezing may damage the protein structure and render the product unsuitable for use
- Light: Keep in the original outer carton to protect from light. Prolonged exposure to light can degrade albumin
- Shelf life: Refer to the expiry date printed on the label and carton. Do not use after the stated expiry date
- After opening: Once the container has been opened or punctured, the contents should be used immediately. From a microbiological perspective, the product should be used at once. If not used immediately, in-use storage times and conditions are the responsibility of the user
- Visual inspection: Before use, inspect the solution. It should be clear and slightly viscous. Do not use solutions that are cloudy, contain particles, or show signs of deterioration
- Disposal: Any unused product or waste material should be disposed of in accordance with local regulations for biological waste and pharmaceutical products
It is important to note that albumin solutions do not contain antimicrobial preservatives. Therefore, once the seal is broken, there is a risk of microbial contamination if the product is not used promptly. Multi-dose use from a single container is not recommended.
What Does Crealb Contain?
Crealb contains human albumin as its active ingredient at a concentration of 200 g/L (20%). The solution also contains sodium, stabilisers, and water for injections. It is manufactured from pooled human plasma donations with multiple viral safety steps.
Active Ingredient
The active substance is human albumin, present at a concentration of 200 g/L. This corresponds to a 20% solution. Human albumin is a protein with a molecular weight of approximately 66,500 daltons. At least 95% of the protein content is albumin, in compliance with European Pharmacopoeia monograph requirements for human albumin solutions.
Excipients
The solution contains the following excipients (inactive ingredients):
- Sodium chloride: To achieve physiological osmolality and provide sodium ions
- Sodium caprylate (sodium octanoate): Stabiliser to protect albumin during the pasteurisation (heat treatment) process
- N-acetyltryptophan (sodium acetyltryptophanate): Stabiliser to protect against thermal denaturation
- Water for injections: Solvent
The sodium content of the solution is approximately 130–160 mmol/L. This should be taken into account for patients on sodium-restricted diets or those with conditions affected by sodium balance. The solution does not contain blood group antibodies, isoagglutinins, or preservatives.
Manufacturing and Viral Safety
Crealb is manufactured by fractionation of pooled human plasma from tested, approved blood donations. The manufacturing process includes the following viral safety measures:
- Donor screening: Individual donations are tested for HBsAg, anti-HIV, anti-HCV, and other markers
- Plasma pool testing: Pooled plasma is tested by nucleic acid testing (NAT) for HIV, HBV, HCV, and HAV
- Pasteurisation: The solution is heated at 60°C for 10 hours in the final container, which effectively inactivates enveloped and non-enveloped viruses
- Fractionation: The Cohn-Oncley cold ethanol fractionation process provides inherent viral removal capacity
Frequently Asked Questions About Crealb
Crealb is a concentrated human albumin solution (200 g/L) used for restoration and maintenance of circulating blood volume when volume deficiency has been demonstrated. It is commonly used in conditions such as hypovolaemia, liver cirrhosis with ascites (particularly during large-volume paracentesis), severe burns, nephrotic syndrome with severe oedema, and as replacement fluid in therapeutic plasma exchange. It is always administered in a hospital setting under medical supervision.
Crealb contains 200 g/L (20%) human albumin, making it a hyperoncotic (concentrated) solution. In contrast, 5% (50 g/L) albumin solutions are iso-oncotic, meaning they have a similar osmotic pressure to normal plasma. The key practical difference is that 20% albumin draws fluid from the tissues into the bloodstream, making it ideal for patients with oedema and hypoalbuminaemia. The 5% solution primarily acts as a volume expander without the same fluid-mobilising effect. Your physician will choose the appropriate concentration based on your clinical needs.
Human albumin is a natural component of blood plasma and has been used in pregnancy for decades without evidence of harm to the mother or foetus. No controlled clinical trials have been conducted specifically with Crealb in pregnant women. However, albumin infusions have been used safely in pregnancy-related conditions such as pre-eclampsia and HELLP syndrome. The treating physician will assess the clinical need and potential benefits before administering albumin during pregnancy.
Crealb is manufactured from pooled human plasma and undergoes rigorous viral safety measures including donor screening, nucleic acid testing of plasma pools, and pasteurisation at 60°C for 10 hours. These measures effectively inactivate known enveloped and non-enveloped viruses. No confirmed cases of viral transmission have been documented with modern licensed albumin products. However, as with all plasma-derived products, a theoretical risk of transmitting known or unknown infectious agents cannot be entirely excluded.
During a Crealb infusion, your medical team will monitor your blood pressure, heart rate, and breathing. You should report any symptoms such as chills, flushing, itching, hives, difficulty breathing, chest tightness, or feeling faint. These could be signs of an allergic reaction. The most common concern with concentrated albumin is fluid overload, which may cause shortness of breath, swelling, or a rapid increase in blood pressure. Your healthcare team is trained to recognise and manage these complications promptly.
The duration of a Crealb infusion depends on the dose prescribed and the infusion rate deemed safe for the individual patient. A typical infusion of 100 mL at a rate of 1–2 mL per minute takes approximately 50–100 minutes. Patients with cardiac or renal impairment may require slower infusion rates, extending the administration time. Your healthcare team will determine the appropriate rate based on your clinical condition and tolerance.
References
This article is based on the following peer-reviewed sources, clinical guidelines, and regulatory documents. All medical claims are supported by evidence level 1A where available.
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