PACKAGE LEAFLET: INFORMATION FOR THE USER

ALBUNORM 5%
50 g/l, solution for infusion
Human albumin
Please read the entire leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse immediately. See section 4.

Table of contents:
1. What Albunorm 5% is and what it is used for
2. Important information before using Albunorm 5%
3. How to use Albunorm 5%
4. Possible side effects
5. How to store 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 following 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 5%

When not to use Albunorm 5%

if the patient is allergic to human albumin preparations or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Albunorm 5%, discuss it with your doctor, pharmacist, or nurse.
Exercise particular caution when using Albunorm 5% in the following cases:

if there is a risk of circulatory overload, e.g. in patients with severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, conditions associated with excessive bleeding, very low erythrocyte count, or anuria.
if symptoms of circulatory overload (headache, respiratory disturbances, distended neck veins) or elevated blood pressure occur. 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 taken 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/infectious markers,
inclusion by manufacturers of appropriate virus inactivation or removal steps during production.

Nevertheless, when administering products derived from human blood or plasma, transmission of infectious agents 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 product be recorded each time Albunorm 5% is administered to a patient, to ensure traceability between the patient and the product batch.

Albunorm 5% and other medicines
No interactions between human albumin and other medicines have been reported. Nevertheless, Albunorm 5% should 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 intends 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 5% contains sodium
This medicine contains 331–368 mg of sodium (a main component of common salt) in each 100 ml. This corresponds to 18.4% of the maximum recommended daily dietary sodium intake for adults.

3. HOW TO USE THE MEDICINAL PRODUCT ALBUNORM 5%

The medicinal product Albunorm 5% is in the form of a ready-to-use solution for intravenous infusion (intravenous drip).
The dosage and infusion rate (rate of intravenous administration) depend on the patient's condition.
The medicinal product should be used according to the physician's instructions.
Instructions

The medicinal product should be warmed to room temperature or body temperature before use.
The solution should be clear and free from precipitate.
Any unused solution should be discarded.
Consult a physician or pharmacist if you have any other questions regarding the use of this medicinal product.

Use of a higher than recommended dose of Albunorm 5%
If the dose and infusion rate are too high, headache, high blood pressure, and breathing 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 product may cause adverse reactions, although not everyone experiences them.
Adverse reactions following human albumin infusion are rare and usually resolve after slowing down or stopping the infusion.
Rare adverse reactions (affecting 1 to 10 users in 10,000) include:
facial flushing, urticaria, fever, and nausea.
Very rare adverse reactions (affecting less than 1 user in 10,000) include:
anaphylactic shock due to hypersensitivity reaction.
Adverse reactions for which the frequency is not known (cannot be estimated from available data) include:
disturbance of consciousness, headache, increased or decreased heart rate, elevated or reduced blood pressure, sensation of warmth, shortness of breath, nausea, urticaria, swelling around eyes, nose and mouth, rash, excessive sweating, fever, chills.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can 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 Warszawa
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 5%

Keep this 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 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.
Use immediately after opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Albunorm 5% contains:

The active substance is human albumin 50 g/l obtained from human plasma (bottles of 100, 250 and 500 ml).
Other components of the medicine are: sodium chloride, N-acetyl-DL-tryptophan, caprylic acid and water for injections.

What Albunorm 5% looks like and contents of the pack
Albunorm 5% is an infusion solution in a 100 ml bottle (pack containing 1 and 10 bottles).
Albunorm 5% is an infusion solution in a 250 ml bottle (pack containing 1 and 10 bottles).
Albunorm 5% is an infusion solution in a 500 ml bottle (pack containing 1 bottle).
The solution is clear, yellow, amber or greenish.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Albunorm: Czech Republic, Denmark, Italy
Albunorm 5%: Belgium, Bulgaria, Cyprus, Germany, Ireland, Iceland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom
Albunorm 50 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