ALBUNORM 20%, 200 g/l SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Albunorm 20%

200 g/l, Solution for infusion

Human albumin

Contents of the pack:

1. What Albunorm 20% is and what it is used for
2. What you need to know before you use 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 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.

2. What you need to know before you use Albunorm 20%

Do not useAlbunorm 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 using Albunorm 20%.

Be especially careful with Albunorm 20%

• If you have a special risk due to an increase in blood volume, for example, in cases of severe heart disease, arterial hypertension, dilated veins in the esophagus, fluid in the lungs, coagulation disorders, severe decrease in red blood cells or absence of urine.
• When there are signs of increased blood volume (headache, respiratory disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately.
• When there are signs of an allergic reaction. The infusion should be stopped immediately.
• When used in patients with severe head injury due to trauma.

Virus safety

When human blood or plasma-derived medicines are administered, the occurrence of diseases due to the transmission of 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:

• Donor selection through medical examination.
• In individual donations and plasma pools, the presence of markers for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) is ruled out.
• In plasma pools, the presence of genetic material used by HCV to reproduce is ruled out.
• Validated inactivation/removal procedures included in the production process. These procedures are considered effective for HIV, HCV, hepatitis A virus (HAV), and HBV.

The inactivation/removal 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 Pharmacopoeia and is therefore considered a safe product with regard to 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.

Using Albunorm 20% with other medicines

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no indication that human albumin alters the ability to drive or use machines.

Albunorm 20% contains sodium

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

3. How to use Albunorm 20%

Albunorm 20% is ready to use for infusion ("drip") in a vein. The dosage and infusion rate (speed at which albumin is administered in 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 not have 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 breathing difficulties. The infusion should be stopped immediately and your doctor will decide if any other treatment is necessary.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects after infusion of human albumin are rare and usually disappear when the infusion rate is decreased or stopped.

Rare (affect 1 to 10 patients in 10,000):

Flushing, urticaria, fever, and nausea.

Very rare (affect less than 1 patient in 10,000):

Shock due to hypersensitivity reaction.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through www.notificaRAM.es. By reporting side 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 which is stated on the label and carton. The expiry date is the last day of the month stated.

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

Once the infusion container is opened, the contents should be used immediately.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Albunorm 20%

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

Appearance of Albunorm 20% and pack contents

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

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

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

Not all pack sizes may be marketed in all countries.

Marketing authorisation holder and manufacturer:

Octapharma S.A.

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

Ed. Dublín, 2ª Planta

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-Roblau, Germany

This medicine is authorised in the Member States of the European Economic Area 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 last revision of this leaflet: April 2020.

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