PATIENT INFORMATION LEAFLET

Albunorm 20%

200 g/l, Solution for infusion

Human albumin

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

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

No useAlbunorm 20%

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

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

Be especially careful with Albunorm 20%

• If you have a special risk due to increased blood volume, for example, in case of severe heart disease, high blood pressure, dilated veins in the esophagus, fluid in the lungs, blood clotting disorders, severe anemia, or absence of urine.
• If there are signs of increased blood volume (headache, respiratory disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately.
• If there are signs of an allergic reaction. The infusion should be stopped immediately.
• If used in patients with severe brain injury due to trauma.

Security against viruses

When administering blood-derived or plasma human medications, the appearance of diseases due to the transmission of infectious agents cannot be completely excluded. This also applies to the possible transmission of unknown pathogens. However, the risk of transmission of infectious agents is reduced by:

-Medical screening of donors.

-Exclusion of the presence of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) markers in individual donations and plasma mixtures.

-Exclusion of the presence of HCV genetic material in plasma mixtures.

-Validated inactivation/elimination procedures included in the production process. These procedures are considered effective for HIV, HCV, hepatitis A virus (HAV), and HBV.

The inactivation/elimination procedures may have limited value for non-enveloped viruses such as parvovirus B19 and other transmissible infectious agents.

Albunorm 20% contains albumin manufactured according to the specifications and processes established in the European Pharmacopeia and is therefore considered a safe product regarding virus transmission.

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

Use of Albunorm 20% with other medications

Until now, no interactions of human albumin with other products have been known. However, Albunorm 20% in solution should not be mixed in the same infusion with other medications, whole blood, or red blood cell concentrate.Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Pregnancy and lactation

Human albumin is a normal constituent of human blood. No adverse effects are known 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 machines

No indication is given that human albumin alters the ability to drive or operate machines.

Albunorm 20% contains sodium

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

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

Instructions

• The product must be brought to room or body temperature before use.
• The solution must be crystal clear and must not have any deposits.
• Any unused solution must be discarded.
• If you have any other 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 breathing difficulties. Infusion must be stopped immediately and your doctor will decide if any further treatment is necessary.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects after human albumin perfusion are infrequent and usually disappear when the perfusion rate is reduced or stopped.

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

Flush, urticaria, fever, and nausea.

Very Rare(affect fewer than 1 patient in every 10,000):

Shock due to hypersensitivity reaction.

Unknown frequency, cannot be estimated with available data.

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

Reporting 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 prospectus. You can also report them directly through www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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

Do not use this medication after the expiration date that appears on the label and the box. The expiration date is the last day of the month indicated.

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

Once the infusion container has been opened, the contents must be used immediately.

The solution must be crystal clear or slightly opalescent. Solutions that are turbid or have deposits must not be used.

Medications must not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

l Composition of Albunorm 20%

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

Appearance of Albunorm 20% and contents of the packaging

Albunorm 20% is a perfusion solution in a 50 ml perfusion bottle, packaging of 1 and 10 units

Albunorm 20% is a perfusion solution in a 100 ml perfusion bottle, packaging of 1 and 10 units

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

It may not be marketed in all countries.

Holder of the marketing authorization and responsible for manufacturing:

Octapharma S.A.

vda. Castilla, 2. (P.E. San Fernando)

Ed. Dublín, 2nd Floor

28830 San Fernando de Henares

Madrid

Responsible for manufacturing:

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-Roblau, Germany

This medicine is authorized in the member states of the European Economic Area with 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 the last review of this leaflet: April 2020 .

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/