Albiomin 20% (200 g/L) solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Albiomin 20% (200 g/l), solution for infusion

Human albumin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not adverse reactions listed in this leaflet. See section 4.

Contents of the leaflet

1. What Albiomin 20% (200 g/l) is and what it is used for
2. What you need to know before using Albiomin 20% (200 g/l)
3. How to use Albiomin 20% (200 g/l)
4. Possible adverse reactions
5. How to store Albiomin 20% (200 g/l)
6. Contents of the pack and other information

1. What Albiomin 20% (200 g/l) is and what it is used for

Albiomin 20% (200 g/l) is an intravenous infusion solution. One litre of solution contains 200 g of human plasma protein, of which at least 96% is human albumin.

Albiomin 20% (200 g/l) is used to restore and maintain circulating blood volume when there is a low blood volume and when the use of a colloid, such as albumin, is required.

2. What you need to know before using Albiomin 20% (200 g/l)

Do not use Albiomin 20% (200 g/l)

• if you are allergic to albumin preparations or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

If allergic or anaphylactic reactions are suspected, the infusion must be stopped immediately. In case of shock, standard medical guidelines for shock treatment should be followed.

The infusion should also be stopped if you develop any of the following conditions as signs of cardiovascular overload (hypervolemia):

• Headache
• Dyspnea (difficulty breathing)
• Jugular vein distension (fluid accumulation in a neck vein)
• Increased blood pressure
• Increased venous pressure (elevated pressure in the veins)
• Pulmonary edema (fluid in the lungs)

Tell your doctor if you have any of the following conditions:

• Heart failure (decompensated heart failure)
• High blood pressure (hypertension)
• Dilated veins in the esophagus (esophageal varices)
• Fluid in the lungs (pulmonary edema)
• Tendency to abnormal or spontaneous bleeding (hemorrhagic diathesis)
• Reduced red blood cells (severe anemia)
• Decreased or absent urine production (renal and post-renal anuria)

Your doctor will take appropriate precautions. Your doctor will monitor your circulatory status, electrolyte balance, and blood volume.

Information regarding transmission of infectious agents

When medicines derived from human plasma or blood are administered, certain measures are taken to prevent infections from being transmitted to patients. These measures include:

• Careful selection of donors to exclude those at risk of carrying infectious diseases,
• Testing for specific markers of infections in individual donations and plasma pools,
• Inclusion of manufacturing steps designed to inactivate and/or remove viruses.

Despite these measures, the possibility of transmitting infectious agents cannot be completely ruled out when medicines derived from human blood or plasma are administered. This also applies to emerging viruses or those of unknown origin, as well as other types of infections.

There have been no reports of virus transmission associated with albumin manufactured according to the requirements and processes defined in the European Pharmacopoeia.

It is strongly recommended that each time a dose of Albiomin 20% (200 g/l) is administered, the product name and batch number be recorded to maintain a traceable record of batches used.

Use of Albiomin 20% (200 g/l) with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether Albiomin 20% (200 g/l) can be used during pregnancy and breastfeeding.

Driving and using machines

Albiomin 20% (200 g/l) has no effect on the ability to drive or operate machinery.

Albiomin 20% (200 g/l) contains sodium

This medicine contains approximately 140 mg of sodium (main component of table/cooking salt) in each 50 ml vial. This corresponds to 7.0% of the maximum daily recommended sodium intake for an adult.

This medicine contains approximately 280 mg of sodium (main component of table/cooking salt) in each 100 ml vial. This corresponds to 14.0% of the maximum daily recommended sodium intake for an adult.

3. How to use Albiomin 20% (200 g/l)

Treatment with Albiomin 20% (200 g/l) is generally administered in a hospital by a doctor or nurse.

Human albumin may be given directly into a vein or diluted in 0.9% sodium chloride.

Dosage and frequency of administration

The amount of Albiomin 20% (200 g/l) you will receive depends on your body size, the disease, and fluid or protein losses.

Your doctor will determine the required amount of Albiomin 20% (200 g/l) and the frequency of administration to achieve the appropriate blood levels.

If you use more Albiomin 20% (200 g/l) than you should

This is very unlikely, but if it happens, your doctor will know what to do.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

In case of overdose or accidental ingestion, call the Toxicology Information Service immediately at telephone number 915620420.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following symptoms, inform your doctor immediately:

• skin rash
• itching
• wheezing
• difficulty breathing
• swelling of the eyelids, face, lips, throat, or tongue
• extremely low blood pressure with symptoms such as dizziness, confusion, fainting, rapid pulse

These may be signs of an allergic reaction or, in rare cases, a severe allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

The following adverse effects have been reported for Albiomin 20% (200 g/l) or are known from other human albumin products:

Frequency not known (cannot be estimated from available data):

• hypersensitivity, anaphylactic reaction, anaphylactic shock
• Contraction of the lung (bronchospasm)
• Increased heart rate (tachycardia)
• Shock
• Nausea
• Skin reactions (redness, urticaria, itching, erythema, rash)
• Chills
• Fever
• Low blood pressure (hypotension)
• Decreased oxygen saturation
• Leakage at injection site (extravasation)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Albiomin 20% (200 g/l)

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and the outer carton.

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

Do not store above 25°C.

Do not freeze.

Once opened, the product must be used immediately.

Immediately before administration, check that the solution is clear and transparent. The product must not be used if the solution is cloudy or if visible particles are present.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Packaged contents and additional information

Composition of Albiomin 20% (200 g/l)

Each 50 ml vial of solution contains 10 g of human plasma protein, of which at least 96% is human albumin.

Each 100 ml vial of solution contains 20 g of human plasma protein, of which at least 96% is human albumin.

The other components are sodium caprylate (16 mmol/l), sodium chloride (63 mmol/l), N-acetyl-tryptophanate (16 mmol/l), and water for injections.

Appearance of Albiomin 20% (200 g/l) and pack size

Clear, slightly viscous liquid; practically colourless, yellow, amber, or green.

Glass vial with 50 ml

Glass vial with 100 ml

Marketing Authorization Holder and Manufacturer

Biotest Pharma GmbH

Landsteinerstraße 5

63303 Dreieich

Germany

Telephone: +49 6103 801-0

Fax: +49 6103 801-150
Email: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Grifols Movaco, S.A.

Can Guasc, s/n – Parets del Vallès

08150 Barcelona

Spain

Date of latest revision of this package leaflet: 11/2024

This information is intended for healthcare professionals only:

Special warnings and precautions for use

The colloidal osmotic effect of 200 g/l human albumin is approximately four times that of blood plasma. Therefore, when administering concentrated albumin, adequate hydration of the patient must be ensured. Patients must be carefully monitored to avoid circulatory overload and hyperhydration.

Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.

If relatively large volumes are to be replaced, coagulation and haematocrit must be monitored. Care must be taken to ensure adequate replacement of other blood constituents (coagulation factors, electrolytes, platelets, and erythrocytes).

Hypervolaemia may occur if the dose and infusion rate are not adjusted according to the patient's circulatory status.

Interaction with other medicinal products and other forms of interaction

No specific interactions of human albumin with other medicinal products are known.

Dosage and method of administration

Dosage

The required dose should be based on measurement of circulating volume and not on determination of plasma albumin levels.

If human albumin is to be administered, the patient's haemodynamic status should be regularly assessed; this may include monitoring of:

• arterial blood pressure and pulse
• central venous pressure
• pulmonary artery wedge pressure
• diuresis
• electrolytes
• haematocrit / haemoglobin

Method of administration

Intravenous route.

Human albumin may be administered directly intravenously, or may be diluted in an isotonic solution (e.g.: 0.9% sodium chloride).

During plasmapheresis, the infusion rate should be adjusted to the exchange rate.

Handling instructions

Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.

If large volumes are to be administered, the product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain deposits, as this may indicate protein instability or contamination.

Once the vial has been opened, the contents should be used immediately.

Any unused medicinal product and materials that have come into contact with it must be disposed of in accordance with local regulations.