Albunorm 20%

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALBUNORM 20%
200 g/l, solution for infusion
Human albumin
Read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other individuals, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse immediately. See section 4.

Table of contents of the leaflet:
1. What Albunorm 20% is and what it is 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 ALBUNORM 20% IS AND WHAT IT IS USED FOR

Albunorm 20% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions.
This medicine is administered to patients to restore circulating blood volume in cases of documented hypovolemia.

2. IMPORTANT INFORMATION BEFORE USING ALBUNORM 20%

When not to use Albunorm 20%

• If the patient is allergic to human albumin preparations or to any of the other components 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 particular caution with Albunorm 20%:

• If there is a risk of circulatory overload, e.g., in cases of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, conditions associated with excessive bleeding, very low red blood cell count, or anuria.

20201001_pil_666_PL_05.04

• If symptoms of circulatory overload occur (e.g., headache, respiratory distress, jugular vein distension) or elevated blood pressure. In such cases, the infusion must be stopped immediately.
• If symptoms of an allergic reaction occur. In such cases, the infusion must be stopped immediately.
• When administering to patients with severe traumatic brain injury.

Viral safety

For medicinal products derived from human blood or plasma, appropriate measures are applied to prevent transmission of infections to patients. These include:

• Strict selection of blood and plasma donors to exclude carriers of infection,
• Testing of individual donations and plasma pools for specific viral/infection markers,
• Implementation by manufacturers of appropriate steps in the production process to inactivate or remove viruses.

Despite these measures, transmission of infectious agents by products derived from human blood or plasma cannot be completely ruled out. This includes unknown viruses and other known or unknown pathogens.
No cases of viral infection transmission have been reported with albumin products manufactured in accordance with the European Pharmacopoeia guidelines.
It is strongly recommended that the name and batch number of the Albunorm 20% product be recorded each time it is administered to a patient, to ensure traceability between the patient and the product batch.

Albunorm 20% and other medicines

No interactions between human albumin and other medicines have been reported. Nevertheless, Albunorm 20% must not be mixed in the same infusion with other medicines, whole blood, or red blood cell concentrates. Inform your doctor or pharmacist about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding

Human albumin is a natural component of human blood.
No harmful effects have been observed when this medicine was used during pregnancy or breastfeeding.
Particular caution should be exercised when restoring blood volume in pregnant women.
Consult your doctor before using any medicine.

Driving and operating machinery

Human albumin has not been shown to impair the ability to drive or operate machinery.

Albunorm 20% contains sodium

The medicine contains 331–368 mg of sodium (the main component of table salt) in each 100 ml. This corresponds to 18.4% of the maximum recommended daily dietary sodium intake for adults.

3. HOW TO USE ALBUNORM 20%

Albunorm 20% is a ready-to-use solution for intravenous infusion (drip infusion).
20201001_pil_666_PL_05.04
The dosage and infusion rate (rate of intravenous administration) depend on the patient's condition.
The medicine should be used as directed by the physician.

Instructions

• The medicine should be warmed to room temperature or body temperature before use.
• The solution should be clear and free from precipitate or particles.
• Any unused solution should be discarded.
• Consult your doctor or pharmacist if you have any questions regarding the use of this medicine.

Administration of a higher than recommended dose of Albunorm 20%
If the dose or infusion rate is too high, headache, high blood pressure, and respiratory disturbances may occur.
The infusion should be stopped immediately; the physician will decide whether further treatment is necessary.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions following infusion of human albumin are rare and usually resolve after slowing down or stopping the infusion.

Rare adverse reactions (occurring in 1 to 10 out of 10,000 users) include:
facial flushing, urticaria, fever, and nausea.

Very rare adverse reactions (occurring in less than 1 out of 10,000 users) include:
anaphylactic shock due to hypersensitivity reaction.

Adverse reactions for which frequency is not known (cannot be estimated from available data) include:
confusion, headache, increased or decreased heart rate, increased or decreased blood pressure, sensation of heat, shortness of breath, nausea, urticaria, swelling around eyes, nose and mouth, rash, excessive sweating, fever, chills.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02222 Warsaw
Tel.: +48 22 49 21 301
Faks: +48 22 49 21 309
e-mail: [email protected]

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE ALBUNORM 20%

20201001_pil_666_PL_05.04
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 packaging.
The expiry date refers to the last day of the stated 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 if the solution is cloudy or contains a precipitate.
After opening, use immediately.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Albunorm 20% contains:

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

What Albunorm 20% looks like and contents of the pack
Albunorm 20% is an infusion solution in a 50 ml bottle (pack containing
1 and 10 bottles).
Albunorm 20% is an infusion solution 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 Authorisation Holder and Manufacturer
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

This medicinal product is authorised in the European Economic Area countries 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
20201001_pil_666_PL_05.04