Albutein

Package Leaflet: Information for the User

Albutein 50 g/l, Solution for Infusion

Human albumin

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

• Keep this package 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

• 1. What Albutein 50 g/l is and what it is used for
• 2. Important information before using Albutein 50 g/l
• 3. How to use Albutein 50 g/l
• 4. Possible side effects
• 5. How to store Albutein 50 g/l
• 6. Contents of the pack and other information

1. What Albutein 50 g/l is and what it is used for

Albutein 50 g/l is a solution for intravenous infusion containing proteins derived from human plasma (plasma proteins), i.e., the liquid part of human blood. Each bottle/bag contains a solution of plasma proteins with a concentration of 50 g per liter, of which at least 95% is human albumin. The medicinal product belongs to a group of medicines called plasma substitutes and plasma protein fractions. Albutein 50 g/l is used to supplement and maintain blood volume in cases where a deficiency in blood volume has been demonstrated and the use of a plasma substitute is indicated. Albutein may be used in all age groups. Use in children, see section 4. If you have any questions about the use of Albutein 50 g/l, ask your doctor.

2. Important information before using Albutein 50 g/l

When not to use Albutein 50 g/l

Warnings and precautions

Before starting treatment with Albutein 50 g/l, discuss it with your doctor, pharmacist, or nurse. You should be particularly careful when using Albutein 50 g/l:

In the case of medicines produced from human blood or plasma, appropriate precautions are taken to prevent the transmission of infections to the patient. These precautions include:

• appropriate selection of blood and plasma donors to exclude individuals who may be carriers of infections;
• testing of individual donations and plasma pools for the presence of viruses/infections;
• inclusion in the manufacturing process of steps aimed at inactivating or removing viruses.

Despite this, it is not possible to completely eliminate the risk of transmitting an infection when using medicines prepared from human blood or plasma. This applies to all previously unknown or newly emerging viruses and other types of infections. No cases of viral infections caused by albumins produced in accordance with the requirements of the European Pharmacopoeia, using widely accepted processes, have been reported. It is strongly recommended that, each time a patient receives a dose of Albutein 50 g/l, the name and batch number of the medicine should be recorded in order to maintain a record of the batches used.

Children

The safety and efficacy of Albutein 50 g/l in children have not been established in controlled clinical trials. However, clinical experience with the use of albumin in children suggests that no harmful effects are to be expected, provided that the dose is adjusted to avoid overloading the circulatory system. See also section 4.

Albutein 50 g/l and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. There are no known specific interactions between human albumin and other medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. The safety of Albutein 50 g/l in pregnant women has not been established in controlled clinical trials. However, clinical experience with the use of albumin does not indicate any harmful effects on the course of pregnancy or on the fetus and newborn. Breastfeeding It is not known whether Albutein 50 g/l passes into breast milk. The passage of human albumin into breast milk has not been studied in animals. A decision should be made to either discontinue breastfeeding or discontinue Albutein therapy, taking into account the benefit of breastfeeding to the child and the benefit of Albutein therapy to the mother. Fertility No studies have been conducted on the effects of Albutein 50 g/l on fertility in animals. However, human albumin is a natural component of human blood.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Albutein 50 g/l contains sodium

The medicine contains 333.5 mg of sodium (the main component of common salt) in each 100 ml bottle/bag, 833.8 mg of sodium in each 250 ml bottle/bag, and 1667.5 mg of sodium in each 500 ml bottle/bag. This corresponds to 16.7%, 41.7%, and 83.4% of the maximum recommended daily intake of sodium in the diet for adults, respectively. The medicine contains potassium, less than 39 mg (1 mmol) per bottle/bag, which means the medicine is considered "potassium-free".

3. How to use Albutein 50 g/l

Albutein 50 g/l is intended for use in hospitals, so it will be administered in a hospital by medical personnel. The dose and infusion rate of Albutein 50 g/l administered to the patient, as well as the frequency of administration and duration of treatment, will be adjusted to the individual needs of the patient. These parameters will be calculated by the doctor.

Use of a higher dose of Albutein 50 g/l than recommended

If you think you have been given a higher dose of Albutein 50 g/l than necessary, inform your doctor immediately.

Missing a dose of Albutein 50 g/l

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Albutein 50 g/l can cause side effects, although not everybody gets them.

• Mild reactions may occur rarely, such as sudden redness of the skin, skin rash, fever, and nausea.
• Severe allergic reactions (anaphylactic shock) may occur very rarely.
• Information on the risk of viral infections, see section 2.

Additional side effects in children

There are no detailed data available to determine the possibility of different side effects in this patient group.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Albutein 50 g/l

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (EXP)". Do not store above 30°C. Do not freeze. Store the bottle/bag in the outer packaging to protect from light. Do not use this medicine if you notice that the solution is cloudy or has sediment. After opening the packaging to prepare the infusion set, the contents should be used immediately. 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 Albutein 50 g/l contains

• The active substance is human albumin. One milliliter of Albutein 50 g/l contains 50 mg of plasma proteins, of which at least 95% is human albumin.
• The other ingredients are sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, and water for injections.

Produced from human plasma. For more information on the ingredients, see also "Albutein 50 g/l contains sodium" at the end of section 2.

What Albutein 50 g/l looks like and contents of the pack

Albutein 50 g/l is a solution for infusion. The solution is clear, slightly viscous, almost colorless, yellow, amber, or green. Albutein 50 g/l may be supplied:

Pack size:

• 1 bottle in a box containing 100 ml, 250 ml, or 500 ml;
• 1 bag in a box containing 100 ml, 250 ml, or 500 ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

INSTITUTO GRIFOLS, S.A., c/Can Guasch, 2. Pol. Ind. Levante, Parets del Valles, 08150 Barcelona, Spain

Marketing authorization holder and importer

INSTITUTO GRIFOLS, S.A., c/Can Guasch, 2, Pol. Ind. Levante, Parets del Valles, 08150 Barcelona, Spain For more information, contact the representative of the marketing authorization holder. Grifols Polska Sp. z o. o., Ul. Siedmiogrodzka 9, 01-204 Warsaw, Tel: + 48 22 378 85 61

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

Bulgaria, Croatia, Finland, France, Greece, Ireland, Iceland, Germany, Poland, Portugal, Czech Republic, Romania, Slovakia, Sweden: Albutein 50 g/lDenmark, Norway: Albumin Grifols 50 g/lItaly: Albumina Umana Grifols 50 g/lSpain: Albutein 50 g/l solución para perfusiónDate of last revision of the leaflet:December 2023 Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Information intended for healthcare professionals only:

• Albutein 50 g/l can be administered directly intravenously.
• Do not mix human albumin with other medicinal products, whole blood, or red blood cell concentrates.
• Do not use cloudy or sediment-containing solutions. This may indicate protein instability or solution contamination. After opening the packaging, its contents should be used immediately.
• Infusion is performed intravenously using a sterile, single-use infusion set that does not contain pyrogens. Before inserting the infusion set into the bottle cap, it should be disinfected with an appropriate disinfectant solution. After connecting the infusion set to the bottle, its contents should be used immediately.
• The infusion rate should be adjusted to the individual situation and indication. During plasma exchange, the infusion rate of plasma should be adjusted to the rate of its removal. Fluid overload may occur if the dose and infusion rate are not adjusted to the patient's circulatory status. If the first clinical signs of circulatory overload (headache, respiratory distress, jugular venous distension) or increased blood pressure occur, the infusion should be stopped immediately.
• If a large volume is to be administered, the medicinal product should be warmed to room temperature or body temperature before use.
• During albumin administration, the patient's electrolyte balance should be monitored and appropriate measures taken to maintain or restore it.
• Ensure adequate substitution of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
• Any unused product or waste material should be disposed of in accordance with local requirements.

Bag:

• Do not remove the protective packaging until the product is ready for use. Moisture or condensation may be visible in the protective packaging. This is normal and does not affect the quality or safety of the albumin solution.
• Before use, check the bag for integrity by squeezing it firmly. If a leak is detected, the solution should be discarded.
• To connect the infusion set, break the safety seal by twisting the valve.
• After connecting the infusion set to the bag, its contents should be used immediately.
• Do not use bags in series connections. Such use may cause air embolism due to the suction of residual air from the primary bag before the end of the infusion of the fluid from the secondary bag.