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.
Alburex 20, 200g/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
What Alburex is Alburex is a plasma substitute. How Alburex works Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicines and toxins. The albumin protein in Alburex is isolated from human blood plasma. Therefore the albumin works exactly as if it was your own protein. What Alburex is used for Alburex is used to restore and stabilise the circulating blood volume. It is normally used under intensive care situations, when your blood volume has decreased critically. This may be the case e.g.: due to severe loss of blood after an injury, or due to a large surface burn The choice of using Alburex will be made by your doctor. It will depend on your individual clinical situation.
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What you need to know before you take it
Alburex Read this section carefully. The information given should be taken into consideration by you and your doctor before you are given Alburex.
Do NOT use Alburex If you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or healthcare professional before you are given Alburex. Which circumstances increase the risk of having side effects? Your doctor or healthcare professional will take special care if an abnormal increase in blood volume (hypervolaemia) or blood dilution (haemodilution) could be dangerous for you. Examples of such conditions are: heart insufficiency which needs to be treated with medicines (decompensated cardiac insufficiency) high blood pressure (hypertension) expansion of the gullet vein (oesophageal varices) abnormal accumulation of liquid in the lung (pulmonary oedema) predisposition for bleeding (haemorrhagic diathesis) severe decrease of red blood cells (severe anaemia) severe decrease of urine excretion because of renal impairment or outflow impairment (renal and post-renal anuria) Tell your doctor or healthcare professional before treatment if at least one of these conditions applies to you. When stopping the infusion may be required? Allergic reactions (hypersensitivity reactions) may occur and may very rarely be severe enough to cause shock (see also section 4 'Possible side effects'). Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of Alburex. He or she will decide to stop the infusion completely and start the appropriate treatment. An abnormal increase in blood volume (hypervolaemia) may occur if the dosage and infusion rate are not adequately adjusted to your condition. This may lead to an overload of the heart and circulatory system (cardiovascular overload). First signs of such an overload are headache, breathing difficulty or swelling of your neck veins (jugular vein congestion). Tell your doctor or healthcare professional immediately if you notice such signs. He or she will stop the infusion and monitor your circulation as necessary. Information on safety with respect to infections 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: 2
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 and 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 are given a dose of Alburex the name and batch number of the product are recorded, in order to maintain a record of the batches used. Other medicines and Alburex No specific interactions of Alburex with other medicines are known. However, always tell your doctor or healthcare professional before treatment if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-feeding. Your doctor will decide whether you can receive Alburex during your pregnancy or while you are breast-feeding. The use of Alburex in pregnant or breast-feeding women has not been studied separately. Nevertheless, medicines containing human albumin have been used in pregnant or breastfeeding women. The experience showed that no harmful effects on the course of pregnancy, or on the foetus and the newborn are to be expected. Driving and using machines No effects of Alburex on the ability to drive and use machines have been observed. Alburex contains sodium This medicine contains approximately 3.2 mg sodium per ml of solution (140 mmol/l). Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet. 3.
How to take it
Alburex
Alburex is given to you by your doctor or healthcare professional. It is intended only for infusion into your veins (intravenous infusion). The product should be warmed to room or body temperature before it is given.
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Your doctor decides how much Alburex you will receive. The amount and infusion rate depends on your individual requirements. Your doctor or healthcare professional will regularly monitor important blood flow values like: your blood pressure, your pulse rate, your urine output, your blood tests. These values are monitored to determine the right dose and infusion rate. Alburex 5 must not be mixed with other medicinal products or blood-derived products. Alburex 20 must not be mixed with other medicinal products (except dilution solvents such as 5% glucose and 0.9% sodium chloride) and blood-derived products. If you are given more Alburex than you should Alburex is administered under medical supervision only. An overdosage is therefore very unlikely to occur. An abnormal increase in blood volume (hypervolaemia) may occur if the dosage and infusion rate are too high. This may lead to an overload of the heart and circulatory system (cardiovascular overload). First signs of such an overload include: headache, breathing difficulty, swelling of your neck veins (jugular vein congestion). Tell your doctor or healthcare professional immediately if you notice such symptoms. Your doctor or healthcare professional may also detect signs like an increased blood pressure, a raised central venous pressure, an abnormal accumulation of liquid in the lung (pulmonary oedema). In all these cases, he or she will stop the infusion and monitor your circulation as necessary. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects may occur even when you have previously received Alburex and had tolerated it well. General experience with human albumin solutions showed that the following side effects may be observed. 4
Allergic reactions (hypersensitivity reactions) may occur and may very rarely (less than 1 in 10,000 persons treated) be severe enough to cause shock. Symptoms of an allergic reaction may include any, some or many of the following: skin reactions, e.g. redness, itching, swelling, blistering, rash or hives (itchy bumps) difficulty breathing, e.g. wheezing, chest tightness, shortness of breath or cough swelling of the face, eyelids, lips, tongue or throat cold-like symptoms, e.g. stuffy or runny nose, sneezing, red, itchy, swollen or watery eyes headache, stomach ache, nausea, vomiting or diarrhoea. Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of Alburex. In this case, he or she will stop the infusion and start the appropriate treatment.
The following mild side effects may occur rarely (between 1 in 1,000 and 1 in 10,000 persons treated): flushing itchy rash (urticaria) fever nausea They will normally disappear rapidly when the infusion is slowed down or the infusion is stopped. The same side effects have been observed with Alburex since the product is on the market. However, the exact frequency of these side effects is not known. Reporting of side effects If you get any side effects, talk to your doctor or healthcare professional. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the UK Yellow Card Scheme at 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. 5.
How to store it
Alburex
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after the abbreviation «EXP». The expiry date refers to the last day of that month. Once the vial has been opened, the contents should be used immediately. 5
Do not store above 25 °C. Do not freeze. Keep the vial in the outer carton in order to protect from light. Do not use this medicine if you notice that the solution is cloudy or has particles. 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.
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Contents of the pack and other information
What Alburex contains The active substance is human albumin. Alburex 5 is a solution containing 50 g/l of total protein, of which at least 96% is human albumin. One vial of 250 ml containing 12.5 g of human albumin. One vial of 500 ml containing 25 g of human albumin. Alburex 20 is a solution containing 200 g/l of total protein, of which at least 96% is human albumin. One vial of 50 ml contains 10 g of human albumin. One vial of 100 ml contains 20 g of human albumin. The other ingredients are sodium N-acetyltryptophanate, sodium caprylate, sodium chloride, and water for injections. What Alburex looks like and contents of the pack Alburex is a solution for infusion. The solution is clear and slightly viscous. It may be almost colourless or yellow, amber or green. Pack sizes: Alburex 5: 1 vial per pack (12.5 g/250 ml, 25 g/500 ml) Alburex 20: 1 vial per pack (10 g/50 ml, 20 g/100 ml) Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany
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For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom CSL Behring UK Ltd. Tel: +44 (0)1444 447405 This leaflet was last revised in 04/2024
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Frequently asked questions about Alburex 20, 200g/l, solution for infusion
How do I take Alburex 20, 200g/l, solution for infusion?
Alburex 20, 200g/l, solution for infusion comes as infusion containing 200g. 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 Alburex 20, 200g/l, solution for infusion?
The active substance in Alburex 20, 200g/l, solution for infusion is human albumin.
Are there equivalent medicines to Alburex 20, 200g/l, solution for infusion?
Medicines with the same active substance, strength and form include: Human Albumin Grifols 200 g/l, solution for infusion, Zenalb 20 (200 g/l) solution for infusion, Zenbumin 20, 200 g/l, Solution for Infusion. In total there are 4 equivalent products. 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 Alburex 20, 200g/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 Alburex 20, 200g/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.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.
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
The posology in children and adolescents (0-18 years) should be adjusted to the patient's individual requirements.
Method of administration
Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 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
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 assure 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 infusion rate 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.
Alburex 20 contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).
That should be taken into consideration for patients on a controlled sodium diet.
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.
It is strongly recommended that every time that Alburex 20 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
No animal reproduction studies have been conducted with Alburex 20.
Its safety for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Breast-feeding
It is unknown whether Alburex 20 is excreted in human milk. Since human albumin is a normal constituent of human blood, treatment of the nursing mother with Alburex 20 is not expected to present a risk to the breastfed newborn/infant.
Fertility
No animal reproduction studies have been conducted with Alburex 20. However, human albumin is a normal constituent of human blood and harmful effects on fertility are not expected.
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
4.8. Undesirable effects
Summary of the safety profile
Mild reactions with human albumin solutions 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 allergic reactions such as anaphylactic shock may occur. In these cases, the infusion should be stopped immediately and an appropriate treatment should be initiated.
Tabulated list of adverse reactions
The summary table below presents the adverse reactions which have been observed with Alburex during the post-marketing phase, according to the MedDRA system organ classification (SOC and Preferred Term Level).
As the post-marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions.
Hence the frequency category “not known (cannot be estimated from the available data)” is used.
MedDRA System Organ Class
(SOC)
Adverse Reaction
Frequency
Immune system disorders
Hypersensitivity reactions (including anaphylaxis and shock)
Not known
Gastrointestinal disorders
Nausea
Not known
Skin and subcutaneous tissue disorders
Flush, urticaria
Not known
General disorders and administration site conditions
Fever
Not known
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:
UK: Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store
IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; Email: [email protected]
For safety information with respect to transmissible agents, see section 4.4.
4.9. Overdose
Hypervolaemia may occur if the dosage and infusion rate 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 Alburex 20, 200g/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
- albunorm5%, 50g/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