Albunorm 20%, 200 g/l solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Albunorm 20%
200 g/l, Solution for infusion
Human albumin

Package leaflet contents:

1. What Albunorm 20% is and what it is used for
2. What you need to know before using Albunorm 20%
3. How to use Albunorm 20%
4. Possible side effects
5. Storage of Albunorm 20%
6. Contents of the pack and other information

1. What Albunorm 20% is and what it is used for

Albunorm 20% belongs to the therapeutic group: blood substitutes and plasma protein fractions.

This product is administered to patients to restore and maintain circulating blood volume when a volume deficiency has been demonstrated.

2. What you need to know before using albunorm 20%

Do not use Albunorm 20%

If you are allergic to human albumin preparations or to any of the other components of this medicine (listed in section 6) Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Albunorm 20%.

Take special care with Albunorm 20%

• If you are at particular risk due to increased blood volume, for example, in cases of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, coagulation disorders, severe reduction in red blood cells, or absence of urine production.
• If signs of increased blood volume occur (headache, breathing difficulties, jugular vein distension) or increased blood pressure. Infusion must be stopped immediately.
• If signs of an allergic reaction occur. Infusion must be stopped immediately.
• When used in patients with severe brain injury due to trauma.

Viral safety

When medicines derived from human blood or plasma are administered, the risk of transmitting infectious agents cannot be completely excluded. This also applies to the possible transmission of pathogens of unknown nature. However, the risk of transmission of infectious agents is reduced by:

• Careful selection of donors through medical screening.
• Testing of individual donations and pooled plasma for markers of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV).
• Testing pooled plasma for the presence of HCV genetic material.
• Validated viral inactivation/removal procedures included in the manufacturing process. These procedures are considered effective against HIV, HCV, hepatitis A virus (HAV), and HBV.

Viral inactivation/removal procedures may have limited effectiveness against non-enveloped viruses such as parvovirus B19 and other transmissible infectious agents.

Albunorm 20% contains albumin manufactured according to the specifications and processes defined in the European Pharmacopoeia and is therefore considered safe with regard to viral transmission.

It is strongly recommended that each time you receive a dose of Albunorm 20%, the name and batch number of the product be recorded, in order to maintain a record of batches used.

Use of Albunorm 20% with other medicines

To date, no interactions between human albumin and other products are known. However, Albunorm 20% solution must not be mixed in the same infusion with other medicines, whole blood, or packed red blood cells. Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Pregnancy and lactation

Human albumin is a normal constituent of human blood. There are no known harmful effects when this product is used during pregnancy or lactation. Special attention should be paid to adjusting blood volume in pregnant women.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

There is no indication that human albumin affects the ability to drive or operate machinery.

Albunorm 20% contains sodium

This medicine contains 331 - 368 mg of sodium (the main component of table/cooking salt) in each 100 ml. This corresponds to 18.4% of the maximum daily recommended sodium intake for an adult.

3. How to use Albunorm 20%

Albunorm 20% is ready for use in intravenous infusion ("drip"). The dosage and infusion rate (the speed at which albumin is administered into a vein) will depend on your particular condition. Your doctor will decide the best treatment for you.

Instructions

• The product should be brought to room or body temperature before use.
• The solution should be clear and free from deposits.
• Any unused solution should be discarded.
• If you have any further questions about the use of this product, ask your doctor or pharmacist.

If you use more Albunorm 20% than you should

If the dosage and infusion rate are too high, you may experience headache, increased blood pressure, and difficulty breathing. The infusion must be stopped immediately, and your doctor will decide whether any further treatment is necessary.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects after human albumin infusion are uncommon and usually resolve when the infusion rate is reduced or stopped.

Rare (affects between 1 and 10 patients in every 10,000):

Flushing, urticaria, fever, and nausea.

Very rare (affects fewer than 1 in 10,000 patients):

Shock due to hypersensitivity reaction.

Frequency not known, cannot be estimated from the available data:

Confusion, headache, increased or decreased heart rate, high or low blood pressure, sensation of heat, difficulty breathing, nausea, rash, swelling around the eyes, nose, or mouth; skin eruption, increased sweating, fever, chills.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Albunorm 20%

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 carton. The expiry date is the last day of the month indicated.

Store below +25 °C. Keep in the original container to protect from light. Do not freeze.

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

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain deposits.

Medicines should 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. Contents of the container and other information

Composition of Albunorm 20%

• The active substance is 200 g/l human albumin derived from human plasma. (50 ml, 100 ml vials)
• The other components are sodium chloride, N-acetyl-DL-tryptophan, caprylic acid, and water for injections.

Appearance of Albunorm 20% and contents of the container

Albunorm 20% is a solution for infusion in a 50 ml infusion vial, pack sizes of 1 and 10 units.

Albunorm 20% is a solution for infusion in a 100 ml infusion vial, pack sizes of 1 and 10 units.

The solution is clear, yellow, amber, or green.

Not all pack sizes may be marketed in every country.

Marketing Authorization Holder and Manufacturing Responsibility:

Octapharma S.A.

Vda. Castilla, 2 (San Fernando Industrial Estate)

Ed. Dublín, 2nd Floor

28830 San Fernando de Henares

Madrid

Manufacturers:

Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaerstrasse 235, 1100 Vienna, Austria

Octapharma S.A.S., 72 rue du Maréchal Foch, 67380 Lingolsheim, France

Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden

Octapharma Produktionsgesellschaft Deutschland mbH, Wolfgang-Marguerre-Allee 1, 31832 Springe, Germany

Octapharma Dessau GmbH, Otto-Reuter-Str. 3, 06847 Dessau-Roßlau, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Albunorm: Denmark, Italy

Albunorm 20%: Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Ireland, Iceland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom

Albunorm 200 g/l: Austria, Estonia, France, Finland, Hungary, Latvia, Lithuania, Norway, Romania, Sweden, Slovenia

Date of latest review of this package leaflet: April 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/