Albutein

Package Leaflet: Information for the User

Albutein 200 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. 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 package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Albutein 200 g/l and what is it used for
• 2. Important information before using Albutein 200 g/l
• 3. How to use Albutein 200 g/l
• 4. Possible side effects
• 5. How to store Albutein 200 g/l
• 6. Contents of the package and other information

1. What is Albutein 200 g/l and what is it used for

Albutein 200 g/l is a solution for intravenous infusion containing proteins obtained from human plasma (plasma proteins), i.e., the liquid part of human blood. Each vial/bottle/bag contains a solution of plasma proteins at a concentration of 200 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 200 g/l is used to supplement and maintain blood volume in cases where a deficiency of blood volume has been demonstrated and the use of a plasma substitute is indicated. Albutein can be used in all age groups. Use in children, see section 4. If you have any questions about the use of Albutein 200 g/l, ask your doctor.

2. Important information before using Albutein 200 g/l

When not to use Albutein 200 g/l

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Albutein 200 g/l, discuss it with your doctor, pharmacist, or nurse. Particular care should be taken when using Albutein 200 g/l:

• If the patient is at increased risk of increased blood volume, for example, has severe heart disease, high blood pressure, dilated esophageal veins, fluid in the lungs, blood clotting disorders, severe red blood cell disease, or anuria (lack of urination).
• If signs of increased blood volume (headache, breathing difficulties, jugular vein congestion) or increased blood pressure occur. The infusion should be stopped immediately.
• If signs of an allergic reaction occur. The infusion should be stopped immediately.
• If the medicine is used in patients with severe traumatic brain injury.

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 processing of blood or plasma of steps aimed at inactivating or removing viruses.

Despite this, it is not possible to completely eliminate the risk of transmission of 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 200 g/l, the name and batch number of the medicine be recorded to keep a record of the batches used.

Children

The safety and efficacy of Albutein 200 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 particular attention is paid to the dose to avoid overloading the circulatory system. See also section 4.

Albutein 200 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. No specific interactions between human albumin and other medicines are known.

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 200 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 200 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 for the child and the benefit of Albutein therapy for the mother. Fertility No studies have been conducted on the effects of Albutein 200 g/l on fertility in animals. 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 200 g/l contains sodium

The medicine contains 33.4 mg of sodium (the main component of common salt) in each 10 ml vial, 166.8 mg of sodium in each 50 ml bottle/bag, and 333.5 mg of sodium in each 100 ml bottle/bag. This corresponds to 1.7%, 8.3%, and 16.7% 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 vial/bottle/bag, i.e., the medicine is considered "potassium-free".

3. How to use Albutein 200 g/l

Albutein 200 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 200 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 200 g/l than recommended

If you think you have been given a higher dose of Albutein 200 g/l than necessary, tell your doctor immediately.

Missing a dose of Albutein 200 g/l

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

4. Possible side effects

Like all medicines, Albutein 200 g/l can cause side effects, although not everybody gets them.

• Mild reactions, such as sudden redness of the skin, skin rash, fever, and nausea, may occur rarely.
• 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 is no detailed data to determine the possibility of different side effects in this patient group.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 200 g/l

Store the medicine out of 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 vial/bottle/bag in the outer packaging to protect it from light. Do not use this medicine if you notice that the solution is cloudy or a sediment has formed. After opening the packaging to prepare an 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 that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Albutein 200 g/l contains

• The active substance is human albumin. One milliliter of Albutein 200 g/l contains 200 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 200 g/l contains sodium" at the end of section 2.

What Albutein 200 g/l looks like and what the package contains

Albutein 200 g/l is a solution for infusion. The solution is clear, slightly viscous, almost colorless, yellow, amber, or green. Albutein 200 g/l has been authorized for marketing:

• in vials/bottles made of type II glass with a rubber stopper, aluminum cap, plastic cap, and plastic tear-off ring to ensure tightness. The vial contains 10 ml of product, and the bottle contains 50 ml or 100 ml of product.
• in bags (FlexBag) made of polyethylene in a protective packaging made of polypropylene. The bag contains 50 ml or 100 ml of product.

Package size:

• 1 vial in a box containing 10 ml
• 1 bottle in a box containing 50 ml or 100 ml
• 1 bag in a box containing 50 ml or 100 ml

Not all package 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 for marketing 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 200 g/lDenmark, Norway: Albumin Grifols 200 g/lItaly: Albumina Umana Grifols 200 g/lSpain: Albutein 200 g/l solución para perfusiónDate of last revision of the package 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 200 g/l can be administered directly intravenously. It can also be diluted in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution). The mixture of electrolyte solutions should be prepared under aseptic conditions.
• Albumin solutions should not be diluted with water for injections, as this may cause hemolysis in the patients receiving them.
• Human albumin should not be mixed with other medicinal products, whole blood, or red blood cell concentrates.
• Do not use cloudy or precipitated solutions. This may indicate protein instability or solution contamination. After opening the packaging, its contents should be used immediately.
• Infusion should be performed intravenously using a sterile, single-use infusion set that does not contain pyrogens. Before inserting the infusion set into the vial/bottle, it should be disinfected with an appropriate disinfectant solution. After connecting the infusion set to the vial/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. Hyperolemia may occur if the dose and infusion rate are not adjusted to the patient's circulatory system. If the first clinical signs of circulatory overload (headache, difficulty breathing, jugular vein congestion) 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.
• The 200 g/l albumin solution has a hyperoncotic effect. When administering concentrated albumin, ensure the patient is adequately hydrated.
• Patient monitoring should be performed to prevent circulatory overload and fluid overload.
• During albumin administration, the patient's electrolyte balance should be monitored, and appropriate measures should be taken to maintain or restore it.
• Adequate substitution of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes) should be ensured.
• 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 tightness 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 an air embolism due to the suction of residual air from the main bag before the end of the infusion of the fluid from the additional bag.