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.
albunorm5%, 50g/l, solution for infusion
⚠ 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 Albunorm 5% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions. The product is given to patients to restore and maintain circulating blood volume where a deficiency in volume has been demonstrated.
What you need to know before you take it
E ALBUNORM 5% Do not use Albunorm 5%
if you are allergic to human albumin preparations or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Albunorm 5%.
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Take special care with Albunorm 5%
if you are at special risk from increased blood volume e.g. in case of severe heart disorders, high blood pressure, dilated veins of the oesophagus, fluid in the lung, bleeding disorders, severely lowered red blood cell count or without urine output. when there are signs for increased blood volume (headache, breathing disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately.
when there are signs of an allergic reaction. The infusion should be stopped immediately.
when it is used in patients with severe traumatic brain injury.
Virus safety 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
- testing of each donation and pools of plasma for signs of virus/infections
- steps included by the manufacturers 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 specifications by established processes. It is strongly recommended that every time you receive a dose of Albunorm 5% the name and batch number of the product are recorded in order to maintain a record of the batches used. Other medicines and Albunorm 5% No interactions of human albumin with other products are known so far. However, Albunorm 5% solution should not be mixed in the same infusion with other drugs, whole blood or packed red cells. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding Human albumin is a normal constituent of human blood. No harmful effects are known when this product is used during pregnancy or breast-feeding. Particular care should be taken to adjust blood volume in pregnant women. Ask your doctor for advice before taking any medicine. Driving and using machines There are no indications that human albumin impairs the ability to drive or to operate machines.
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Albunorm 5% contains sodium This medicine contains 331 – 368 mg sodium (main component of cooking/table salt) per 100 ml albumin solution. This is equivalent to up to 18.4% of the recommended maximum daily dietary intake of sodium for an adult.
How to take it
ALBUNORM 5% Albunorm 5% is ready for use as an infusion ("drip") into a vein. The dosage and infusion rate (how quickly you are given albumin into a vein) will depend on your particular condition. Your doctor will decide what treatment is best for you. Instructions
- The product should be brought to room or body temperature before use.
- The solution should be clear and should not have a deposit.
- Any unused solution should be discarded.
- If you have any further questions on the use of this product, ask your doctor or pharmacist. If you use more Albunorm 5% than you should If the dosage and rate of infusion are too high, you may develop headache, high blood pressure and discomfort breathing. The infusion should be stopped immediately and your doctor will decide if any other treatment is necessary. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects after infusion of human albumin are rare and they normally disappear when the infusion-rate is slowed down or stopped. Rare: affects 1 to 10 users in 10,000: Flush, urticaria, fever and nausea. Very rare: affects less than 1 user in 10,000: Shock due to hypersensitivity reaction. Frequency not known: cannot be estimated from the available data: Confusional state; headache; increased or decreased heart rate; high blood pressure or low blood pressure; heat sensation; shortage of breath; nausea; nettle rash; swelling around eyes, nose, mouth; rash; increased sweating; fever; chills.
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Reporting of suspected adverse reactions If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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
ALBUNORM 5% Keep this medicine out of the sight and reach of children. Do not use this medicine after expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light. Do not freeze. Once the infusion container has been opened, the content should be used immediately. The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Albunorm 5% contains
The active substance is 50 g/l human albumin derived from human plasma (bottle of 100, 250, 500 ml). The other ingredients are sodium chloride, N-Acetyl-DL-tryptophan, caprylic acid and water for injections.
What Albunorm 5% looks like and contents of the pack: Albunorm 5% is a solution for infusion in a bottle (100 ml – pack size of 1 and 10) Albunorm 5% is a solution for infusion in a bottle (250 ml – pack size of 1 and 10) Albunorm 5% is a solution for infusion in a bottle (500 ml – pack size of 1) The solution is clear, yellow, amber or green. Not all pack sizes may be marketed in all countries.
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Marketing Authorisation Holder and Manufacturers: Octapharma Ltd. Glassworks House 32 Shudehill Manchester M4 1EZ United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Albunorm: Czech Republic, Denmark, Italy Albunorm 5%: Belgium, Bulgaria, Cyprus, Germany, Ireland, Iceland, Luxemburg, Malta, Netherlands, Poland, Portugal, Slovak Republic, Spain, United Kingdom Albunorm 50 g/l: Austria, Estonia, Finland, France, Hungary, Latvia, Lithuania, Norway, Romania, Sweden, Slovenia Manufacturers: Octapharma Pharmazeutika, Produktionsges.m.b.H., Oberlaaerstrasse 235, 1100 Vienna, Austria Octapharma S.A.S., 72 rue du Maréchal Foch, 67380 Lingolsheim, France Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden Octapharma Produktionsgesellschaft Deutschland mbH, Wolfgang-Marguerre-Allee 1, 31832 Springe, Germany
This leaflet was last revised in 08/2023.
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Frequently asked questions about albunorm5%, 50g/l, solution for infusion
How do I take albunorm5%, 50g/l, solution for infusion?
albunorm5%, 50g/l, solution for infusion comes as infusion containing 50g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in albunorm5%, 50g/l, solution for infusion?
The active substance in albunorm5%, 50g/l, solution for infusion is human albumin.
Are there equivalent medicines to albunorm5%, 50g/l, solution for infusion?
Medicines with the same active substance, strength and form include: Alburex 5, 50g/l, solution for infusion, Human Albumin Grifols 50 g/l, solution for infusion. 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 albunorm5%, 50g/l, solution for infusion, 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 albunorm5%, 50g/l, solution for infusion 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 and 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
Paediatric population
Data on the use of Albunorm 5% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks.
Method of administration
Human albumin can be directly administered by the intravenous route.
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.
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.
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
In a post-hoc follow-up study of critically ill patients with traumatic brain injury, fluid resuscitation with albumin was associated with higher mortality rates than was resuscitation with saline. While the mechanisms underlying this observed difference in mortality are not clear, caution is advised in the use of albumin in patients with severe traumatic brain injury.
200-250 g/l human albumin solutions are relatively low in electrolytes compared to 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.
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 patients 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.
This medicinal product contains 331 - 368 mg sodium per 100 mL albumin solution, equivalent to up to 18.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult
Standard measure 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.
It is strongly recommended that every time that Albunorm 5% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interactions of human albumin with other medicinal products are known.
4.6. Fertility, pregnancy and lactation
Pregnancy
The safety of Albunorm 5% 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.
No animal reproduction studies have been conducted with Albunorm 5%.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
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 case of severe reactions, the infusion should be stopped and an appropriate treatment should be initiated.
The following adverse reactions have been observed for human albumin solutions during the postmarketing phase and can therefore also be expected for Albunorm 5%.
System Organ Class
Reactions
(frequency not known)*
Immune system disorders
anaphylactic shock anaphylactic reaction
hypersensitivity
Psychiatric disorders
confusional state
Nervous system disorders
headache
Cardiac disorders
tachycardia
bradycardia
Vascular disorders
hypotension
hypertension
flushing
Respiratory, thoracic and mediastinal disorders
dyspnoea
Gastrointestinal disorders
nausea
Skin and subcutaneous tissue disorders
urticaria
angioneurotic oedema
rash erythematosus
hyperhidrosis
General disorders and administration site conditions
pyrexia
chills
* cannot be estimated from the available data
For safety 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 albunorm5%, 50g/l, solution for infusion. 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
- Alburex 20, 200g/l, solution for infusion
- Alburex 5, 50g/l, solution for infusion
- Human Albumin Biotest 20%
- 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