Human Albumin 20% Behring, low salt – solution for infusion for blood volume replacement

Human Albumin 20% Behring, low salt (malo soli), 200 g/L, solution for infusion (Human Albumin 20% Behring, malo soli) contains human albumin – a protein naturally present in blood plasma, obtained for this medicine from the plasma of healthy donors. It belongs to the group of blood substitutes and plasma protein fractions and is manufactured by CSL Behring GmbH (Marburg, Nemačka).

According to the package leaflet, Human Albumin 20% Behring, malo soli is used to restore and maintain circulating blood volume when a blood volume deficit has been confirmed and use of a colloid is appropriate. The solution contains 200 g/L protein and is a hyper-oncotic solution – its colloid-osmotic effect is about four times that of blood plasma. It is given only in hospital, as an intravenous infusion administered by healthcare staff.

What is Human Albumin 20% Behring, malo soli used for and how is it given?

Key facts about the medicine

What is Human Albumin 20% Behring, malo soli used for?

According to the package leaflet and the summary of product characteristics, Human Albumin 20% Behring, malo soli is indicated for:

• restoration and maintenance of circulating blood volume where a volume deficiency has been demonstrated and use of a colloid is appropriate.

Whether albumin or an artificial colloid is used, and the dose, is decided by the doctor based on the patient’s clinical condition and official recommendations.

How is it given and dosed?

• The medicine is given in hospital; the dose, infusion rate, frequency and duration are set by the doctor according to the patient’s individual needs.
• The dose depends on the patient’s size, the severity of trauma or illness and continuing fluid and protein losses; circulating blood volume, not plasma albumin level, is measured to determine the dose.
• Albumin is given directly intravenously, undiluted or diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). It must not be diluted with water for injections, as this may cause haemolysis; the infusion rate is adjusted to the situation and indication.
• During administration, blood pressure and pulse, central venous pressure, pulmonary capillary pressure, urine output, electrolytes and haematocrit/haemoglobin are monitored continuously.
• The contents are used immediately after opening; cloudy solutions or solutions with deposits must not be used.

Special patient groups

• Children and adolescents: according to the leaflet, the dose in children and adolescents (0–18 years) is not expected to differ from that in adults.
• Patients with heart, lung or kidney disease: because of the risk of circulatory overload, particularly careful monitoring is needed (see warnings).
• Sodium intake: the solution contains 125 mmol/L sodium – one 50 mL vial contains 144 mg sodium, equivalent to 7.2% of the recommended maximum daily intake for adults; relevant for patients on a low-salt diet.

Contraindications – when the medicine must not be used

Human Albumin 20% Behring, malo soli must not be given:

• in case of hypersensitivity (allergy) to human albumin or to any of the excipients (sodium and potassium ions, caprylate, N-acetyl-DL-tryptophan, chloride ions).

Warnings and precautions

Albumin is used with caution in conditions where an increase in blood volume (hypervolaemia) or haemodilution could pose a special risk:

• decompensated heart failure and high blood pressure;
• oesophageal varices and pulmonary oedema;
• haemorrhagic diathesis (bleeding tendency) and severe anaemia;
• renal and post-renal anuria (absence of urine output).

With the concentrated (20%) solution, adequate hydration of the patient must be ensured. Electrolyte balance is monitored, and when larger volumes are replaced, coagulation and haematocrit are checked and other blood components are replaced as needed. As with all medicines made from human plasma, transmission of infection cannot be totally excluded, although there are no reports of virus transmission with albumin manufactured to European Pharmacopoeia specifications.

Interactions with other medicines, food and drink

No specific interactions of human albumin with other medicines are known. However, the solution must not be mixed with other medicines (except the recommended diluents), whole blood or packed red cells. Tell the doctor about all medicines you take.

Pregnancy and breast-feeding

• Pregnancy and breast-feeding: safety has not been established in controlled clinical trials, but clinical experience with albumin suggests no harmful effects on the course of pregnancy, the foetus or the newborn. The doctor decides on its use.
• Fertility: albumin is a normal component of human blood; no harmful effect is expected.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Possible side effects

Like all medicines, Human Albumin 20% Behring, malo soli can cause side effects, although not everybody gets them.

• Rare (up to 1 in 1,000 patients): flushing with a feeling of warmth, hives, fever, nausea – these usually disappear quickly when the infusion is slowed or stopped.
• Very rare (up to 1 in 10,000): shock due to a severe allergic reaction – the infusion is stopped immediately and appropriate treatment is started.

Overdose, missed dose and stopping treatment

• Overdose: too high a dose or infusion rate may cause hypervolaemia – headache, difficulty breathing, distended neck veins, raised blood and central venous pressure and pulmonary oedema. The infusion is then stopped immediately and haemodynamic parameters are monitored.
• Missed dose and stopping treatment: the medicine is given by hospital staff, who determine the schedule and duration of treatment.

Related information

Human Albumin 20% Behring, malo soli is a hospital medicine; for questions about your treatment, please contact your treating doctor or the hospital pharmacist.

Composition, pack and manufacturer

• Active substance: human albumin – 200 g/L total protein, of which at least 96% is albumin; one 50 mL vial contains at least 9.6 g human albumin.
• Excipients: sodium ions 125 mmol/L; potassium ions max. 2 mmol/L; caprylate 16 mmol/L; N-acetyl-DL-tryptophan 16 mmol/L; chloride ions max. 100 mmol/L; hydrochloric acid or sodium hydroxide (for pH adjustment); water for injections.
• Appearance and pack: clear, slightly viscous liquid, almost colourless, yellow, amber or green; colourless glass vial with a chlorobutyl rubber stopper (latex-free) and flip-off cap; carton with 1 vial of 50 mL.
• Manufacturer: CSL Behring GmbH, Emil-von-Behring-Straße 76, Marburg, Germany. Marketing authorisation holder: PharmaSwiss d.o.o., Batajnički drum 5A, Belgrade.
• Authorisations: 515-01-00620-21-001 of 21 January 2022 (renewal; first authorisation 18 July 1995)

Storage

• Store below 25 °C; do not freeze.
• Keep the vial in the outer carton to protect from light; once opened, the contents must be used immediately.
• Shelf life: 5 years. Do not use a cloudy solution or a solution with deposits.
• Keep out of the sight and reach of children.

Frequently asked questions

What is Human Albumin 20% Behring, malo soli and why is it given?

It is a concentrated (20%) solution of human albumin, a blood plasma protein, with a reduced salt content. It is given in hospital to restore and maintain blood volume when a volume deficit has been confirmed and a colloid is appropriate.

Can Human Albumin 20% Behring, malo soli be obtained in a pharmacy?

No. Its dispensing status in Serbia is SZ – it may only be used in an inpatient healthcare institution, where it is given by healthcare staff.

Which symptoms during the infusion should be reported immediately?

Headache, difficulty breathing, distended neck veins, feeling faint, flushing, hives or itching. These may be signs of circulatory overload or an allergic reaction, and the infusion is then stopped.

What does “low salt” (malo soli) mean?

The solution contains 125 mmol/L sodium, i.e. 144 mg sodium per 50 mL vial (7.2% of the recommended maximum daily intake for adults). The doctor still takes this amount into account in patients on a low-salt diet.

Sources

• ALIMS – Summary of Product Characteristics, Human Albumin 20% Behring, malo soli, 200 g/L, solution for infusion (SmPC, Serbian)
• ALIMS – Package leaflet, Human Albumin 20% Behring, malo soli (PIL, Serbian)

Sources checked on: 25 October 2026.