9/15/24, 11:41 PM Human Albumin Biotest 5% - Summary of Product Characteristics (SmPC) - (emc)

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Human Albumin Biotest 5%

Active Ingredient: human albumin
Company: Grifols UK Ltd See contact details
ATC code: B05AA01

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Healthcare Professionals (SmPC) Patient Leaflet (PIL)

This information is for use by healthcare professionals

Last updated on emc: 01 Jun 2020

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Undesirable Effects | Pharmacological Properties | Interactions | Posology |
Contraindications | Excipients | Storage precautions

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1. Name of the medicinal product

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Human Albumin Biotest 5%, solution for infusion

2. Qualitative and quantitative composition

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Human albumin

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Human Albumin Biotest 5% is a solution containing 50 g/l of total protein of which at least
96% is human albumin.
Each vial of 250 ml contains 12.5 g of human plasma protein of which at least 96% is human
albumin.
The product has a mildly hypooncotic effect.
Excipients with known effect:
One vial of 250 ml Human Albumin Biotest 5% contains approximately 833 mg sodium
(36.25 mmol).
For the full list of excipients, see 6.1.

3. Pharmaceutical form

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Solution for infusion.
A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

4. Clinical particulars

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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 or 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
Intravenous use
Human albumin can be directly administered by the intravenous route.
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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

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.
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.
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
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).

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Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the
patient's circulatory situation. At the fist 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.
Sodium content
This medicinal product contains approximately 833 mg sodium (36.25 mmol) per 250 ml
vial equivalent to 41.7% 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 products are known.

4.6 Fertility, pregnancy and lactation

Pregnancy
The safety of Human Albumin Biotest 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.
Experimental animal studies are insufficient to assess the safety with respect to
reproduction, development of the embryo or fetus, 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 information 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.

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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.

5. Pharmacological properties

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC code:
B05AA01.
Human albumin accounts quantitatively for more than half of the total protein in the
plasma and represents about 10% of the protein synthesis activity of the liver.
Physiochemical data: Human albumin 50 g/l is mildly hypooncotic to normal plasma.
The most important physiological functions of albumin results from its contribution to
oncotic pressure of the blood and transport function. Albumin stabilises circulating blood
volume and is a carrier of hormones, enzymes, medicinal products and toxins.

5.2 Pharmacokinetic properties

Under normal situations the total exchangeable albumin pool is 4-5 g/kg body weight, of
which 40-45% is present intravascularly and 55-60% in the extravascular space. Increased
capillary permeability will alter albumin kinetics and abnormal distribution may occur in
conditions such as severe burns or septic shock.
Under normal conditions, the average half-life of albumin is about 19 days. The balance
between synthesis and breakdown is normally achieved by feedback regulation.
Elimination is predominantly intracellular and due to lysosome proteases.
In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment
during the first 2 hours following infusion. There is considerable individual variation in the
effect on plasma volume. In some patients the plasma volume can remain increased for
some hours. However, in critically ill patients, albumin can leak out of the vascular space in
substantial amounts at an unpredictable rate.

5.3 Preclinical safety data

Human albumin is a normal constituent of the human plasma and acts like the
physiological albumin.
In animals, single dose toxicity testing is of little relevance and does not permit the
evaluation of toxic or lethal doses or of a dose-effect relationship. Repeated dose toxicity
testing is impracticable due to the development of antibodies to heterologous protein in
animal models.

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To date, human albumin has not been reported to be associated with embryo-fetal toxicity,
oncogenic or mutagenic potential.
No signs of acute toxicity have been described in animal models.

6. Pharmaceutical particulars

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6.1 List of excipients

Sodium caprylate(4 mmol/l), Sodium chloride (130 mmol/l), N-acetyltryptophanate(4

mmol/l), water for injections.

6.2 Incompatibilities

Human albumin must not be mixed with other medicinal products, whole blood and
packed red blood cells.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25° C. Do not freeze.

Keep the vial in the outer carton in order to protect from light.

6.5 Nature and contents of container

250 ml of a solution in a vial (Type II glass) with a grey rubber stopper (bromobutyl) and a
cap (aluminium) – pack size of one vial.

6.6 Special precautions for disposal and other handling

Albumin solutions must not be diluted with water for injections as this may cause
haemolysis in recipients.
If large volumes are administered, the product should be warmed to room or body
temperature before use.
The solution should be clear or slightly opalescent. Do not use solutions, which are cloudy
or have deposits. This may indicate that the protein is unstable or that the solution has
become contaminated.
Once the vial has been opened, the contents should be used immediately. Any unused
product should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

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Biotest Pharma GmbH

Landsteinerstraß e 5
63303 Dreieich
Germany
Tel.: +49 6103 801 0
Fax: +49 6103 801 150
Email: [email protected]

8. Marketing authorisation number(s)

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9. Date of first authorisation/renewal of the authorisation

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Date of first authorisation: 24 February 2009
Date of latest renewal: 21.June 2012

10. Date of revision of the text

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08/05/2020

Grifols UK Ltd

Address
3980 - 3990 Enterprise, Cambridge Research Park, Beach Drive, Waterbeach,
Cambridge, Cambridgeshire, CB25 9PE, UK

Telephone
0808 1756 992 (free from mobiles and landlines)

Telephone
0122 339 5700

Fax
+44 (0)1223 395 766

Medical Information e-mail

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[email protected]

WWW
http://www.grifols.com

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