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 Grifols 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 Human Albumin Grifols® 200 g/l is a solution for intravenous infusion containing proteins extracted from human plasma, which is the liquid part of the blood. Each bottle contains a solution of 200 g plasma protein/litre of which at least 95% is human albumin protein. This medicinal product belongs to a group of medicines known as plasma substitutes and plasma protein fractions. Human Albumin Grifols® 200 g/l is used to restore and maintain the circulating blood volume where volume deficiency has been demonstrated, and use of a plasma substitute is appropriate. The choice of an albumin solution rather than an artificial plasma substitute will depend on the clinical situation of the individual patient, based on official recommendations. If you have any questions about the use of Human Albumin Grifols® 200 g/l please ask your doctor.
2. BEFORE YOU USE HUMAN ALBUMIN GRIFOLS® 200 g/l Do not use Human Albumin Grifols® 200 g/l If you are allergic (hypersensitive) to human albumin protein or to any of the other ingredients (see Important information about some of the ingredients of Human Albumin Grifols® 200 g/l at the end of this section).
Id2017-P5 07/11/2022
P-287 Background White Size | Structure (mm) 150 x 340
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Color references
Take special care with Human Albumin Grifols® 200 g/l
- If you think you are suffering from an allergic reaction with breathing difficulties, feeling weak or any other symptoms, the infusion must be stopped immediately.
- Tell your doctor if you think you are suffering from any of the following conditions:
- A weak heart
- High blood pressure
- Oesophageal varices (enlarged veins in the esophagus)
- Pulmonary oedema (liquid accumulation in the lungs)
- Bleeding or blood clotting disorders
- Severe anaemia (absence of red blood cells)
- Problems with urine production These conditions may rule out the use of Human Albumin Grifols® 200 g/l in your treatment, or cause the doctor to modify the dosage/infusion rate to avoid complications. 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, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include 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 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 Human Albumin Grifols® 200 g/l the name and batch number of the product are recorded in order to maintain a record of all batches that have been used. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. No specific interactions of human albumin with other medicines are known. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or breast-feeding you must tell your doctor who will decide if Human Albumin Grifols® 200 g/l can be used. Driving and using machines No effects on the ability to drive and use of machines have been observed. Important information about some of the ingredients of Human Albumin Grifols® 200 g/l Patients on a controlled sodium diet should take into consideration that this medicine contains 166.8 mg (7.3 mmol) sodium per vial of 50 ml, and 333.5 mg (14.5 mmol) sodium per vial of 100 ml. This medicine contains very low levels of potassium.
How to take it
HUMAN ALBUMIN GRIFOLS® 200 g/l Human Albumin Grifols® 200 g/l is a product intended for hospital administration only. It will be administered as an intravenous infusion by medical staff and must not be self administered. The dosage and the infusion rate of Human Albumin Grifols® 200 g/l you receive, as well as the frequency and duration of your treatment, will be adjusted to your individual requirements. This will be calculated for you by your doctor. If you use more Human Albumin Grifols® 200 g/l than you should If you have been given more Human Albumin Grifols® 200 g/l than required, your blood volume may increase. Tell your doctor immediately. Signs of overdose may include: headache, trouble breathing, jugular vein congestion (enlarged veins in the neck), high blood pressure, and pulmonary oedema (liquid accumulation in the lungs). If you forget to use Human Albumin Grifols® 200 g/l Tell your doctor or pharmacist immediately and follow his/her instructions. You must not be given a double dose to make up for a forgotten dose.
150 mm
Possible side effects
Like all medicines, Human Albumin Grifols® 200 g/l can cause side effects, although not everybody gets them.
- Mild reactions such as flush, skin rash, fever and nausea may occur rarely.
- Severe allergic reactions (anaphylactic shock) may occur very rarely. For information on viral safety, see section 2. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist 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: https://yellowcard.mhra.gov.uk. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
HUMAN ALBUMIN GRIFOLS® 200 g/l Keep out of the reach and sight of children. Do not use Human Albumin Grifols® 200 g/l after the expiry date which is stated on the bottle label and carton after EXP. Do not store above 25 oC. Do not freeze. Keep the bottle in the outer carton in order to protect from light. The solution should be clear or slightly opalescent. Do not use Human Albumin Grifols® 200 g/l if you notice that the solution is cloudy or has deposits. Once the bottle has been opened, the contents should be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements. 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.
6. FURTHER INFORMATION What Human Albumin Grifols® 200 g/l contains
- The active substance is human albumin. One millilitre of Human Albumin Grifols® 200 g/l contains 200 mg of human plasma protein, of which at least 95% is human albumin.
- The other ingredients are sodium chloride, sodium caprylate, sodium N-acetyltryptophanate and water for injections. For further information about ingredients see also "Important information about some of the ingredients of Human Albumin Grifols® 200 g/l" at the end of section 2.
340 mm
What Human Albumin Grifols® 200 g/l looks like and contents of the pack Human Albumin Grifols® 200 g/l is a solution for infusion. The solution is clear and slightly viscous; it can be almost colourless, slightly yellow, slightly amber or slightly green. Human Albumin Grifols® 200 g/l is supplied in bottles containing 50 ml and 100 ml of product. Pack size of 1 bottle. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder and Manufacturer: Distributed by: Instituto Grifols, S.A. Grifols UK Ltd. Can Guasch, 2 – Parets del Vallès 3980-3990 Cambridge Research Park 08150 Barcelona – SPAIN Beach Drive Waterbeach Cambridge, CB25 9PE
This leaflet was last revised in 10/2022.
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Frequently asked questions about Human Albumin Grifols 200 g/l, solution for infusion
How do I take Human Albumin Grifols 200 g/l, solution for infusion?
Human Albumin Grifols 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 Human Albumin Grifols 200 g/l, solution for infusion?
The active substance in Human Albumin Grifols 200 g/l, solution for infusion is human albumin.
Are there equivalent medicines to Human Albumin Grifols 200 g/l, solution for infusion?
Medicines with the same active substance, strength and form include: Alburex 20, 200g/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 Human Albumin Grifols 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 Human Albumin Grifols 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
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
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.
For further details, see section 6.6.
4.3. Contraindications
Hypersensitivity to albumin preparations or to any of the excipients.
See special warnings about excipients, section 4.4.
4.4. Special warnings and precautions for use
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. 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 200g/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.
200g/l Human albumin solutions are relatively low in electrolytes compared to the 40-50g/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 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.
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 Human Albumin Grifols 200 g/l 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.
Special warning about excipients:
This medicinal product contains 7.3 mmol (166.8 mg) sodium per vial of 50 ml and 14.5 mmol (333.5 mg) sodium per vial of 100 ml. To be taken into consideration by patients on a controlled sodium diet.
This medicinal product contains potassium, less than 1 mmol (39 mg) per vial.
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. Pregnancy and lactation
The safety of Human Albumin Grifols 200 g/l 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 and the neonate are to be expected.
No animal reproduction studies have been conducted with Human Albumin Grifols 200 g/l.
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.
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 these cases, the infusion should be stopped and an appropriate treatment should be initiated.
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: https://yellowcard.mhra.gov.uk.
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 Grifols 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 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