Package leaflet: Information for the user

Albutein 50 g/l, solution for infusion
human albumin
Please read all of this leaflet carefully before this medicine is given to you because it contains
important information for you.

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 a specific individual. 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Albutein 50 g/l is and what it is used for
What you need to know before you are given Albutein 50 g/l
How to use Albutein 50 g/l
Possible side effects
How to store Albutein 50 g/l
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 at a concentration of 50 g per litre, of which at least 95% is human albumin.
This medicinal product belongs to a group of medicines called plasma substitutes and plasma protein fractions.
Albutein 50 g/l is used to restore and maintain circulating blood volume when a volume deficit has been demonstrated and when 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 regarding the use of Albutein 50 g/l, please consult your doctor.

2. Important information before using Albutein 50 g/l

When not to use Albutein 50 g/l

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

Warnings and precautions
Before starting treatment with Albutein 50 g/l, discuss this with your doctor, pharmacist, or
nurse.
Special caution is required when using Albutein 50 g/l:

If the patient is at particular risk of increased blood volume, for example, has severe heart disease, high blood pressure, oesophageal varices, pulmonary oedema, coagulation disorders, severe red blood cell disorders, or anuria (lack of urine production).
If symptoms of increased blood volume (headache, breathing difficulties, jugular vein distension) or increased blood pressure occur. The infusion must be stopped immediately.
If symptoms of an allergic reaction occur. The infusion must be stopped immediately.
If the medicine is administered to patients with severe traumatic brain injury.

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

careful 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 of steps in the manufacturing process of blood or plasma intended to inactivate or remove viruses.

Nevertheless, it is not possible to completely eliminate the risk of transmitting infection when
using medicines prepared from human blood or plasma. This applies to all currently unknown or newly emerging viruses and other types of infections.
No cases of viral infections caused by albumin manufactured 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 be recorded to maintain traceability of administered batches.

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 harmful effects are not expected, provided particular attention is paid to dosing to avoid circulatory overload. See also section 4.

Albutein 50 g/l and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No specific interactions between human albumin and other medicines are known.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist 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 albumin use does not indicate harmful effects on pregnancy, the fetus, or the newborn.

Breastfeeding
It is not known whether Albutein 50 g/l passes into human milk. Passage of human albumin into milk has not been studied in animals. A decision should be made whether to continue/stop breastfeeding or to continue/stop administration of Albutein 50 g/l, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Albutein 50 g/l for the mother.

Fertility
No studies have been conducted on the effects of Albutein 50 g/l on reproduction in animals.
However, human albumin is a natural component of human blood.

Driving and operating machinery
No influence on the ability to drive or operate machinery has been observed.

Albutein 50 g/l contains sodium
The medicine contains 333.5 mg of sodium (the main component of table salt) in each 100 ml vial/bag, 833.8 mg of sodium in each 250 ml vial/bag, and 1667.5 mg of sodium in each 500 ml vial/bag.
This corresponds to 16.7%, 41.7%, and 83.4% of the maximum recommended daily dietary intake of sodium for adults, respectively.
The medicine contains potassium, less than 39 mg (1 mmol) per vial/bag, meaning the medicine is considered “potassium-free”.

3. How to use Albutein 50 g/l

Albutein 50 g/l is intended for hospital use and will therefore be administered in a hospital setting by qualified medical personnel.
The dose and infusion rate of Albutein 50 g/l, as well as the frequency and duration of treatment, will be adjusted according to the individual patient's needs. These parameters will be determined by the physician.
Administration of a higher than recommended dose of Albutein 50 g/l
If the patient believes that a higher than necessary dose of Albutein 50 g/l has been administered, they should immediately inform the doctor.
Missed dose of Albutein 50 g/l
Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

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

Additional adverse reactions in children
There are no detailed data available to determine the possibility of occurrence of various adverse reactions in this patient group.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Albutein 50 g/l

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container following “Expiry date (EXP)”.
Do not store above 30°C.
Do not freeze.
Keep the bottle/bag in the outer packaging to protect from light.
Do not use this medicine if the solution appears cloudy or if a precipitate is present.
After opening the container for preparation of the infusion set, the contents should be used immediately.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Albutein 50 g/l contains

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

Manufactured from human plasma.
For additional information about 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, and almost colourless, yellow,
amber, or greenish.
Albutein 50 g/l may be supplied:

in type II glass bottles with a chlorobutyl rubber stopper, aluminium seal, plastic flip-off cap, and a plastic shrink band ensuring tightness. The bottle contains 100 ml, 250 ml, or 500 ml of product.
in bags (FlexBag) made of polyethylene, contained in a protective polypropylene overwrap. The bag contains 100 ml, 250 ml, or 500 ml of product.

Pack sizes:

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
INSTITUTO GRIFOLS, S.A.
c/Can Guasch, 2. Pol. Ind. Levante
Parets del Valles
08150 Barcelona, Spain
Marketing Authorisation Holder and Importer
INSTITUTO GRIFOLS, S.A.
c/Can Guasch, 2, Pol. Ind. Levante
Parets del Valles
08150 Barcelona, Spain
For further information, contact the representative of the Marketing Authorisation Holder.
Grifols Polska Sp. z o.o.
Ul. Siedmiogrodzka 9
01-204 Warsaw
Tel: + 48 22 378 85 61
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria, Croatia, Finland, France, Greece, Ireland, Iceland, Germany, Poland, Portugal,
Czech Republic, Romania, Slovakia, Sweden: Albutein 50 g/l
Denmark, Norway: Albumin Grifols 50 g/l
Italy: Albumina Umana Grifols 50 g/l
Spain: Albutein 50 g/l solución para perfusión
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Information intended for healthcare professionals only:

The medicinal product Albutein 50 g/l can be administered directly by intravenous route.
Do not mix human albumin with other medicinal products, whole blood, or red blood cell concentrates.
Do not use solutions that are cloudy or contain sediment. This may indicate protein instability or contamination of the solution. After opening the container, its contents should be used immediately.
Infusion should be administered intravenously using a sterile, single-use, non-pyrogenic infusion set. Before inserting the infusion set spike into the stopper, disinfect it with an appropriate antiseptic solution. After connecting the infusion set to the bottle, the contents should be used immediately.
The infusion rate should be adjusted according to the individual patient's condition and indication. During plasma exchange procedures, the rate of plasma infusion should be adjusted to the rate of plasma removal. Hyper-volemia may occur if the dose and infusion rate are not adjusted to the patient's circulatory status. If clinical signs of cardiovascular overload occur (headache, dyspnoea, jugular vein distension), or if arterial pressure, central venous pressure increases, or pulmonary oedema develops, the infusion must 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, monitor the patient's electrolyte balance and take appropriate measures to maintain or restore it.
Ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets, and erythrocytes).
Any unused portions of the product should be disposed of in accordance with local regulations.

Bag:

Do not remove the protective overwrap until the product is ready for use. Moisture or condensation may be visible inside the protective overwrap. This is normal and does not affect the quality or safety of the albumin solution.
Before use, check the bag for integrity by firmly squeezing it. If leakage is detected, discard the solution.
To connect the infusion set, break the seal by twisting the valve.
After connecting the infusion set to the bag, the contents should be used immediately.
Do not use bags in series connections. This may result in air embolism due to aspiration of residual air from the primary bag before completion of fluid administration from the secondary bag.