Albunorm 5%, 50 g/l solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Albunorm 5%

50 g/l, Solution for infusion

Human albumin

Package leaflet contents:

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

1. What Albunorm 5% is and what it is used for

Albunorm 5% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions.

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

2. What you need to know before using Albunorm 5%

Do not use Albunorm 5%

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 5%.

Take special care with Albunorm 5%

• If you are at special 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 output.
• If there are signs of increased blood volume (headache, breathing difficulties, jugular vein distension) or increased blood pressure. The infusion must be stopped immediately.
• If there are signs of an allergic reaction. The infusion must be stopped immediately.
• When used in patients with severe brain injury due to trauma.

Virus safety

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

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

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

Albunorm 5% contains albumin manufactured according to the specifications and processes defined in the European Pharmacopoeia and is therefore considered safe with regard to virus transmission.

It is strongly recommended that each time you receive a dose of Albunorm 5%, the name and batch number of the product be recorded in order to maintain a record of batches used.

Use of Albunorm 5% with other medicines

To date, no interactions between human albumin and other medicinal products are known. However, Albunorm 5% solution must not be mixed in the same infusion with other medicines, whole blood, or red blood cell concentrate. Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy and lactation

Human albumin is a normal constituent of human blood. No harmful 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 Use of Machines

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

Albunorm 5% 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.

This product contains sodium and potassium and may be harmful to individuals on a low-sodium or low-potassium diet. Inform your doctor if this applies to you.

3. How to use Albunorm 5%

Albunorm 5% 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 individual condition. Your doctor will decide the most appropriate treatment for you.

Instructions

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

If you use more Albunorm 5% 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 infusion of human albumin are uncommon and usually resolve when the infusion rate is reduced or the infusion is stopped.

Rare (affects between 1 and 10 patients in 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 5%

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 refers to 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 infusion 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 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. Contents of the pack and other information

Composition of Albunorm 5%

• The active substance is 50 g/l human albumin derived from human plasma. (Bottles of 100, 250, 500 ml)
• The other components are sodium chloride, N-acetyl-DL-tryptophan, caprylic acid, and water for injections.

Appearance of Albunorm 5% and contents of the pack

Albunorm 5% is a perfusion solution in a 100 ml infusion bottle, pack size of 1 and 10 units

Albunorm 5% is a perfusion solution in a 250 ml infusion bottle, pack size of 1 and 10 units

Albunorm 5% is a perfusion solution in a 500 ml infusion bottle, pack size of 1 unit

The solution is clear, yellow, amber or green.

Not all pack sizes may be marketed in all countries.

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 5%: Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Ireland, Iceland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom

Albunorm 50 g/l: Austria, Estonia, France, Finland, Hungary, Latvia, Lithuania, Norway, Romania, Sweden, Slovenia

Date of latest review of this 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/