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.
Zenbumin 20, 200 g/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
Zenbumin 20 is a solution containing the active substance called human albumin (a protein found naturally in your blood which is needed for many different functions). Human albumin is obtained from blood plasma from screened donors selected from the USA. Zenbumin 20 is used to replace the blood or body fluids that you have lost because of bleeding, surgery, or kidney dialysis (blood "cleaning" by a machine). It contains approximately four times the amount of albumin as normal blood. This medicine is given by injection into a vein (intravenous infusion) either undiluted or in a solution containing 5% glucose or 0.9% sodium chloride. It is only available on a doctor's prescription.
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What you need to know before you take it
e Zenbumin 20
Do not use Zenbumin 20: • if you are allergic to albumin or any of the other ingredients of Zenbumin 20 (listed in section 6). Warnings and precautions Talk to your doctor or nurse before using Zenbumin 20 if any of the following conditions applies to you: • allergic or violent reaction to Zenbumin 20 when injected. Treatment should be stopped immediately • blood problems, especially severe anaemia, or a tendency to bleeding disorders • heart problems where the heart is not pumping properly (heart failure) • high blood pressure (hypertension) • increased blood volume and associated complaints • severe kidney problems or a chronic liver condition • fluid accumulation in the lungs
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You will need to be monitored closely during treatment and should be checked for dehydration and salt (electrolyte) balance in your body. If you start to feel ill, then tell the doctor immediately, because the infusion rate may have to be altered or the treatment stopped. Water should not be added to the Zenbumin 20 solution as it may cause breaking down of some of your red blood cells. Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma derived albumin. 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 Zenbumin 20 the name and batch number of the medicine are recorded in order to maintain a record of the batches used. Children and adolescents The listed warnings and precautions apply to both adults and children. Other medicines and Zenbumin 20 Other medicines are unlikely to affect your treatment with Zenbumin 20. Tell your doctor if you are using, have recently used or might use any other medicines. Zenbumin 20 can be diluted with 5% glucose or 0.9% sodium chloride, but must not be diluted with water for injections. It may also be necessary to receive whole blood, plasma or red blood cells. 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 Zenbumin 20. Driving and using machines No effects on the ability to drive and use machines have been observed. Zenbumin 20 contains sodium If you have been told that you have reduced kidney function or are on a sodium-controlled diet, tell the doctor before he/she gives you the infusion. Each 50 ml bottle contains up to 175 mg sodium (main component of cooking/table salt). This is equivalent to 9% of the recommended maximum daily dietary intake of sodium for an adult. Each 100 ml bottle contains up to 350 mg sodium (main component of cooking/table salt). This is equivalent to 18% of the recommended maximum daily dietary intake of sodium for an adult.
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How to use Zenbumin 20
You will be given Zenbumin 20 as an infusion (an injection given very slowly into a vein). It is unlikely that you will ever have to use Zenbumin 20 yourself as infusion fluids are mainly given by a doctor or nurse. The bottle will be warmed to room temperature before it is used. A thin plastic tube and connector will be inserted into your vein using a needle; the needle will be removed and the connector will be attached to a plastic tube. The bottle of medicine will be attached to the other end of the tube and hung in the plastic sling above you. The medicine will pass down the tube slowly, through a filter and into your body through the thin plastic tube.
How to take it
Your doctor or nurse will calculate how much Zenbumin 20 to give you and how often you should receive it. The amount given will depend on your individual needs. During and after treatment with Zenbumin 20, your doctor may check any or all of the following: • how well the medicine is working by taking your pulse or heart rate • your blood pressure • the pressure inside your heart or lungs by placing a very thin tube into your vein or artery • your heart and breathing will be checked regularly, particularly if you are elderly or very young • blood tests may be carried out to check when the right amounts of protein and sodium are present and treatment can stop Use in children The amount given will depend on the age of your child. Your doctor will take this into account when calculating the amount to give. If you experience headache, difficulty in breathing, jugular vein congestion (signs that your heart is becoming overloaded), or increased blood pressure, raised venous pressure or pulmonary oedema, the infusion will be stopped immediately. This medicine will not interfere with blood tests that are carried out after it has been given. If you are given more Zenbumin 20 than you should If you receive more Zenbumin 20 than you should, you may experience: • high blood pressure, difficulty in breathing (particularly when lying down) and high pressure inside your heart, which your doctor can measure. In the unlikely event that too much medicine is given, the infusion will be stopped immediately and your doctor may give you treatment to remove the excess fluid. If you feel unwell afterwards or have any discomfort, tell your doctor. If you have any further questions on the use of this medicine, ask your doctor or nurse.
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Possible side effects
Like all medicines, Zenbumin 20 can cause side effects, although not everybody gets them. The following side effects may occur infrequently and are usually mild: • feeling sick • flushing • feeling feverish • itchy, raised bumps on the skin • shaking of the body (rigors) • high blood pressure (hypertension) 3
• • • • • • • • •
low blood pressure (hypotension) feeling cold increased heart rate (tachycardia) tremor shortness of breath chest tightness wheezing noisy breathing from throat (stridor) dizziness
If you feel unwell, you must tell your doctor immediately. Some people may have an allergic reaction ranging from a mild skin rash to more serious cases of shock (when your blood pressure falls dangerously low). Symptoms of this are: • dizziness • sweating • cold, clammy skin Your doctor will stop the infusion and treat the allergic reaction if this happens. Please note Although no patients have developed virus infections from human albumin solutions, the possibility of infection from using medicines made from human blood cannot be totally ruled out. This warning includes known, unknown and new viruses and some other germs. Several different steps have been taken to make this possibility very unlikely. These include the careful selection of donors and testing of the plasma they provide for specific types of infection. The method used to produce the medicine from their blood plasma includes steps to kill or remove viruses such as HIV, hepatitis A, hepatitis B, and hepatitis C. 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 the 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.
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How to store it
Zenbumin 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 the carton and bottle after "EXP". The expiry date refers to the last day of that month. Store between 2°C and 25°C. Do not freeze. Use within 3 hours of opening the bottle. Do not use this medicine if you notice the solution is cloudy or has deposits. Keep it in its original carton to protect it from light. Your doctor will discard any unused solution. Medicines should not be disposed of via wastewater or household waste, to help protect the environment.
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Contents of the pack and other information
What Zenbumin 20 contains • The active substance is human albumin. Zenbumin 20 is a solution containing 200 g/l of total protein, of which at least 95% is human albumin. • Human albumin is obtained from blood from screened donors. These donors are selected from the USA. • The other ingredients are sodium, chloride, acetyltryptophanate (as a stabiliser), octanoate (as a stabiliser) and water for injection. What Zenbumin 20 looks like and contents of the pack Zenbumin 20 is a clear, yellow/green thick (viscous) liquid in a glass bottle with a rubber stopper and tamper evident flip-off cap. Zenbumin 20 is available in 50 ml or 100 ml pack sizes. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Bio Products Laboratory Limited, Elstree, Hertfordshire, WD6 3BX United Kingdom Tel: +44 (0) 20 8957 2255 e-mail: [email protected] For any information about this medicine, please contact the Marketing Authorisation Holder. This leaflet was last revised in May 2022
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Frequently asked questions about Zenbumin 20, 200 g/l, Solution for Infusion
How do I take Zenbumin 20, 200 g/l, Solution for Infusion?
Zenbumin 20, 200 g/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 Zenbumin 20, 200 g/l, Solution for Infusion?
The active substance in Zenbumin 20, 200 g/l, Solution for Infusion is human albumin.
Are there equivalent medicines to Zenbumin 20, 200 g/l, Solution for Infusion?
Medicines with the same active substance, strength and form include: Alburex 20, 200g/l, solution for infusion, Human Albumin Grifols 200 g/l, solution for infusion, Zenalb 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 Zenbumin 20, 200 g/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 Zenbumin 20, 200 g/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
Zenbumin 20 is indicated in all patients for the 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
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
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.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived human albumin solutions.
It is strongly recommended that every time that Zenbumin 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.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In the 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 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.
Excipients
This medicinal product contains sodium.
Each 50 ml bottle contains 158.5 – 175 mg sodium, equivalent to 8 – 9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Each 100 ml bottle contains 317 – 350 mg sodium, equivalent to 16 – 18% 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 medicinal products are known.
4.6. Fertility, pregnancy and lactation
Pregnancy
The safety of Zenbumin 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 foetus or the neonate are to be expected.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri-and postnatal development. However, human albumin is a normal constituent of human blood.
Fertility
No animal reproduction studies have been conducted with Zenbumin 20.
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 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 appropriate treatment should be initiated.
Tabulated list of adverse reactions
Adverse reactions are classified according to system organ class and frequency. Frequency groupings are defined 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).
MedDRA Standard System Organ Class
Not known
Nervous system disorders
Tremor
Cardiac disorders
Tachycardia
Dyspnoea
Dizziness
Vascular disorders
Hypertension
Hypotension
Respiratory, thoracic and mediastinal disorders
Stridor
Bronchospasm
General disorders and administration site conditions
Feeling cold
Chest tightness
Rigors
For safety information with respect to transmissible agents, see section 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 the 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 Zenbumin 20, 200 g/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 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