Albunorm 20%

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE USER

ALBUNORM 20%

200 g/l, solution for infusion
Human albumin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

2. Important information before using Albunorm 20%

3. How to use Albunorm 20%

4. Possible side effects

5. How to store Albunorm 20%

6. Contents of the pack and other information

1. WHAT IS ALBUNORM 20% AND WHAT IS IT USED FOR

Albunorm 20% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions.
This medicine is given to patients to restore blood volume in cases of proven volume deficiency.

2. IMPORTANT INFORMATION BEFORE USING ALBUNORM 20%

When not to use Albunorm 20%

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

Warnings and precautions

Before starting treatment with Albunorm 20%, discuss it with your doctor, pharmacist, or nurse.

When to exercise special caution when using Albunorm 20%:

• if there is a risk of circulatory overload, e.g. in cases of severe heart disease, hypertension, variceal bleeding, pulmonary edema, bleeding disorders, very low red blood cell count, or anuria.

20201001_pil_666_PL_05.04

• if symptoms of circulatory overload occur (headache, breathing difficulties, jugular venous distension) or if blood pressure increases. In this case, the infusion should be stopped immediately.
• in case of allergic reaction symptoms. In this case, the infusion should be stopped immediately.
• when used in patients with severe traumatic brain injury.

Viral safety

In the case of medicinal products derived from human blood or plasma, appropriate methods are used to prevent the transmission of infections to patients. These include:

• strict selection of blood and plasma donors to eliminate carriers of infections,
• testing of individual donations and plasma pools for specific viral markers/infections,
• inclusion by manufacturers of appropriate methods to inactivate or remove viruses in the production process.

Despite this, when administering products derived from human blood or plasma, the transmission of an infectious agent cannot be completely ruled out. This also applies to unknown viruses and other known or unknown pathogens.
No cases of transmission of viral infections have been reported using albumin products manufactured in accordance with the European Pharmacopoeia.
It is strongly recommended that each time Albunorm 20% is administered to a patient, the name and batch number of the product be recorded to maintain a link between the patient and the product batch.

Albunorm 20% and other medicines

No interactions between human albumin and other medicines have been found. Nevertheless, Albunorm 20% should not be mixed in the same infusion with other medicines, whole blood, or red blood cell concentrates. Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Human albumin is a natural component of human blood.
No adverse effects have been found when the medicine was used during pregnancy or breastfeeding.
Special caution should be exercised when supplementing blood volume in pregnant women.
Before using any medicine, consult your doctor.

Driving and using machines

No effect of human albumin on the ability to drive and use machines has been found.

Albunorm 20% contains sodium

The medicine contains 331-368 mg of sodium (the main component of common salt) per 100 ml. This corresponds to 18.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. HOW TO USE ALBUNORM 20%

Albunorm 20% is a solution for intravenous infusion (drip infusion).
20201001_pil_666_PL_05.04
The dosage and infusion rate (intravenous administration rate) depend on the patient's condition.
The medicine should be used according to the doctor's instructions.
Instructions

• The medicine should be brought to room temperature or body temperature before use.
• The solution should be clear and free of sediment.
• Any unused solution should be destroyed.
• Consult your doctor or pharmacist if you have any other questions about using the medicine.

Using a higher dose of Albunorm 20% than recommended

If the dose and infusion rate are too high, headache, high blood pressure, and breathing difficulties may occur. The infusion should be stopped immediately, and the doctor will decide whether other treatment is necessary.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects due to human albumin infusion are rare and usually disappear after the infusion is slowed down or stopped.
Rare side effects (affecting 1 to 10 users per 10,000) include:
flushing, urticaria, fever, and nausea.
Very rare side effects (affecting less than 1 user per 10,000) include: anaphylactic shock.
Side effects with unknown frequency (cannot be estimated from available data) include: altered state of consciousness, headache, increased or decreased heart rate, increased or decreased blood pressure, feeling of warmth, shortness of breath, nausea, urticaria, swelling around the eyes, nose, and mouth, rash, increased sweating, fever, chills.
Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALBUNORM 20%

20201001_pil_666_PL_05.04
Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original packaging to protect from light. Do not freeze.
The solution should be clear or slightly opalescent. Do not use a cloudy solution or one that contains sediment.
Use immediately after opening.
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

What Albunorm 20% contains:

• The active substance is human albumin 200 g/l obtained from human plasma (bottles of 50, 100 ml).
• Other ingredients are: sodium chloride, N-acetyl-DL-tryptophan, caprylic acid, and water for injections.

What Albunorm 20% looks like and what the pack contains

Albunorm 20% is a solution for infusion in a 50 ml bottle (pack containing 1 and 10 bottles).
Albunorm 20% is a solution for infusion in a 100 ml bottle (pack containing 1 and 10 bottles).
The solution is clear, yellow, amber, or green.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Albunorm:Czech Republic, Denmark, Italy
Albunorm 20%:Belgium, Bulgaria, Cyprus, Germany, Ireland, Iceland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom
20201001_pil_666_PL_05.04
Albunorm 200 g/l:Austria, Estonia, Finland, France, Hungary, Latvia, Lithuania, Norway, Romania, Sweden, Slovenia

Manufacturer

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

Date of last revision of the leaflet: 01.10.2020

20201001_pil_666_PL_05.04