Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Human Albumin Biotest 20%
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Human albumin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Human Albumin Biotest 20% is a solution for infusion (into a vein). One litre solution contains 200 g human plasma protein of which at least 96% is human albumin. Human Albumin Biotest 20% is used to restore and maintain circulating blood volume where there is a low blood volume and the use of a colloid, such as albumin, is required.
What you need to know before you take it
e Human Albumin Biotest 20% Do not use Human Albumin Biotest 20%:
- if you are allergic to albumin preparations or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Suspicion of allergic or anaphylactic type reactions requires an immediate stop of the infusion. In case of shock, standard medical treatment for shock should be applied. The infusion will also be stopped if you develop any of the following conditions as a sign of cardiovascular overload (hypervolaemia):
- headache
- dyspnoea (difficulties in breathing)
- jugular vein congestion (a build up of fluid in a neck vein)
- increased blood pressure
- raised venous pressure (increased pressure in the veins)
- pulmonary oedema (water on the lungs) Talk to your doctor if you suffer from any of the following conditions:
- heart failure (decompensated cardiac insufficiency)
- high blood pressure (hypertension)
- enlarged veins in the gullet (oesophageal varices)
- water on the lungs (pulmonary oedema) 1/5
- tendency to abnormal or spontaneous bleeding (haemorrhagic diathesis)
- reduced red blood cells (severe anaemia)
- decreased or absent urine production (renal and post-renal anuria) He/she will take the appropriate precautions. You will also be monitored by your doctor to check your circulatory situation with the electrolyte balance and blood volume. Information on transmission of infectious agents When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
- careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
- the testing of each donation and pools of plasma for signs of virus/infections,
- the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. There are no reports of virus infections with albumin manufactured to European Pharmacopoeia requirements by established processes. It is strongly recommended that every time you receive a dose of Human Albumin Biotest 20% the name and batch number of the product are recorded in order to maintain a record of the batches used. Other medicines and Human Albumin Biotest 20% Tell your doctor if you are using, have recently used or might use any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if Human Albumin Biotest 20% may be used during pregnancy and breast-feeding. Driving and using machines Human Albumin Biotest 20% has no known effects on the ability to drive or use machines. Human Albumin Biotest 20% contains sodium This medicinal product contains approximately 140 mg sodium (main component of cooking/table salt) per 50 ml vial. This is equivalent to 7.0% of the recommended maximum daily dietary intake of sodium for an adult. This medicinal product contains approximately 280 mg sodium (main component of cooking/table salt) per 100 ml vial. This is equivalent to 14.0% of the recommended maximum daily dietary intake of sodium for an adult.
How to take it
Human Albumin Biotest 20% Human Albumin Biotest 20% treatment will usually be given in hospital by a doctor or a nurse. Human albumin can be given directly into a vein or diluted in 0.9% sodium chloride. Dosage and Frequency of Administration The amount of Human Albumin Biotest 20% you receive depends on your size, the illness, and on fluid or protein losses. Your doctor will calculate the dose of Human Albumin Biotest 20% and how often you will receive it to obtain the correct levels in your blood. If you use more Human Albumin Biotest 20% than you should 2
This is very unlikely but your doctor will know what to do if this happens. If you have any further questions on the use of this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following effects, tell your doctor immediately:
- rash
- itching
- wheezing
- difficulty breathing
- swelling of the eyelids, face, lips, throat or tongue
- extremely low blood pressure with symptoms like dizziness, confusion, fainting, fast pulse This can be an allergic or in rare cases a serious allergic reaction (anaphylactic shock) or a hypersensitivity reaction. The following side effects have been reported for Human Albumin Biotest 20% or are known from other human albumin products: Not known (frequency cannot be estimated from the available data):
- Hypersensitivity, anaphylactic reaction, anaphylactic shock
- Tightening of the lung (bronchospasm)
- Increased heart rate (tachycardia)
- Shock
- Nausea
- Skin reactions (flushing, urticaria, pruritus, erythema, rash)
- Chills
- Fever
- Low blood pressure (hypotension)
- Reduced oxygen saturation
- Leakage at the injection site (extravasation) Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Human Albumin Biotest 20% Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on label and outer carton. Keep the vial in the outer carton in order to protect from light. Do not store above 25oC. Do not freeze. Once opened, the product should be used immediately. Immediately before administration, check that the solution is clear. The product must not be used if any cloudiness or particles are visible. 3
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Human Albumin Biotest 20% contains Each vial with 50 ml solution contains 10 g of human plasma protein of which at least 96% is human albumin. Each vial with 100 ml solution contains 20 g of human plasma protein of which at least 96% is human albumin. The other ingredients are: sodium caprylate (16 mmol/l), sodium chloride (63 mmol/l), Nacetyltryptophanate (16 mmol/l), water for injections. What Human Albumin Biotest 20% looks like and contents of the pack A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. Glass vial with 50 ml Glass vial with 100 ml Marketing Authorisation Holder and Manufacturer Biotest Pharma GmbH Landsteinerstraße 5 63303 Dreieich Germany Tel.: +49 6103 801-0 Fax: +49 6103 801-150 Email: [email protected] PL 04500/0012 POM This leaflet was last revised in 11/2024. THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: Special warnings and precautions for use The colloid-osmotic effect of human albumin 200 g/l is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients. If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes). Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient's circulatory situation. 4
Interaction with other medicinal products and other forms of interaction No specific interactions of human albumin with other products are known. Posology and method of administration Posology Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:
- arterial blood pressure and pulse rate
- central venous pressure
- pulmonary artery wedge pressure
- urine output
- electrolyte
- haematocrit / haemoglobin Method of administration Intravenous use Human albumin can be directly administered by the intravenous route or it can be diluted in an isotonic solution (e.g. 0.9% sodium chloride). In plasma exchange the infusion rate should be adjusted to the rate of removal. Notes for handling Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients. If large volumes are administered, the product should be warmed to room or body temperature before use. The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated. Once the vial has been opened, the contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.
5
Frequently asked questions about Human Albumin Biotest 20%
What is the active substance in Human Albumin Biotest 20%?
The active substance in Human Albumin Biotest 20% is human albumin.
Are there equivalent medicines to Human Albumin Biotest 20%?
Medicines with the same active substance, strength and form include: Human Albumin Biotest 5%. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Human Albumin Biotest 20%, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Human Albumin Biotest 20% without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: human albumin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.
4.2. Posology and method of administration
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient's individual requirements.
Posology
The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid or protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.
If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:
• arterial blood pressure and pulse rate
• central venous pressure
• pulmonary artery wedge pressure
• urine output
• electrolyte
• haematocrit / haemoglobin
Method of administration
Intravenous use
Human albumin can be directly administered by the intravenous route or it can also be diluted in an isotonic solution (e.g. 0.9% sodium chloride).
The infusion rate should be adjusted according to the individual circumstances and the indication.
In plasma exchange the infusion rate should be adjusted to the rate of removal.
4.3. Contraindications
Hypersensitivity to albumin preparations or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Transmissible agents
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Precautions for use
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock should be implemented.
Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:
• Decompensated cardiac insufficiency
• Hypertension
• Oesophageal varices
• Pulmonary oedema
• Haemorrhagic diathesis
• Severe anaemia
• Renal and post-renal anuria
The colloid-osmotic effect of human albumin 200 g/l is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.
200-250 g/l human albumin solutions are relatively low in electrolytes compared to the 40-50 g/l human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.
If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient's circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.
Sodium content
This medicinal product contains approximately 140 mg sodium (6.1 mmol) per 50 ml vial equivalent to 7.0% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicinal product contains approximately 280 mg sodium (12.2 mmol) per 100 ml vial equivalent to 14.0% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interactions of human albumin with other products are known.
4.6. Fertility, pregnancy and lactation
Pregnancy
The safety of Human Albumin Biotest 20% for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or fetus, the course of gestation and peri- and postnatal development.
However, human albumin is a normal constituent of human blood.
4.7. Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
4.8. Undesirable effects
Summary of the safety profile:
Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped and an appropriate treatment should be initiated.
Tabulated summary of adverse reactions:
The table presented below is according to the MedDRA system organ classification (SOC) and Preferred Term (PT) Level. Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data)
The table represents the safety profile of Human Albumin Biotest 20% based on post-marketing experience. Since the reporting of adverse reactions is voluntary and the number of treated patients is unknown, an exact frequency cannot be estimated.
MedDRA System Organ Class (SOC)
Adverse Reaction
Frequency
Immune system disorders
Anaphylactic shock, anaphylactic reaction, bronchospasm, hypersensitivity
Not known
Cardiac disorders
Tachycardia
Not known
Vascular disorders
Shock, hypotension
Not known
Gastrointestinal disorders
Nausea
Not known
Skin and subcutaneous tissue disorders
Flushing, urticaria, pruritus, erythema, rash
Not known
General disorders and administration site conditions
Chills, pyrexia, application site extravasation
Not known
Investigations
Oxygen saturation decreased
Not known
For safety information with respect to transmissible agents, see 4.4.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.
💬 Ask about this leaflet
Ask anything about Human Albumin Biotest 20%. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Human albumin
- albunorm20%, 200g/l, solution for infusion
- albunorm5%, 50g/l, solution for infusion
- Alburex 20, 200g/l, solution for infusion
- Alburex 5, 50g/l, solution for infusion
- Human Albumin Biotest 5%
- Human Albumin Grifols 200 g/l, solution for infusion
- Human Albumin Grifols 50 g/l, solution for infusion
- Zenalb 20 (200 g/l) solution for infusion
- Zenalb 4.5 (45 g/l) solution for infusion
- Zenbumin 20, 200 g/l, Solution for Infusion