Leaflet: information for the user

Albutein 50 g/l solution for infusion

human albumin

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

-Keep this leaflet,as you may need to read it again.

-If you have any questions, ask your doctor, pharmacist, or nurse.

-This medicine has been prescribed for you only.Do not give it to otherseven if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before using Albutein 50 g/l

3. How to use Albutein 50 g/l

4. Possible side effects

5. Storage of Albutein 50 g/l

6. Contents of the pack and additional information

Albutein 50 g/l is an intravenous infusion solution containing proteins obtained from human plasma (plasma proteins), which is the liquid portion of blood.Each vial/bag contains a solution with 50 g of plasma proteins/l, of which at least 95% is human albumin.

This medication belongs to the group of medications 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 the use of a plasma substitute is considered appropriate.

Albutein can be used in all age groups. For children, see section 4.

If you have any doubts about the use of Albutein 50 g/l, consult your doctor.

No useAlbutein 50 g/l

- If you are allergic (hypersensitive) to the active ingredient or to any of the othercomponents of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Albutein 50 g/l.Be especially careful with Albutein 50 g/l

• If you have a special risk due to an increase in blood volume, for example, in the case of severe heart disease, high blood pressure, dilated veins in the esophagus, fluid in the lungs, blood clotting disorders, severe anemia or absence of urine.
• When there are signs of increased blood volume (headache, respiratory disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately.
• When there are signs of an allergic reaction. The infusion should be stopped immediately.
• When used in patients with severe brain injury due to trauma.

When administering blood or plasma-derived medicines, certain measures are taken to prevent the transmission of infections to patients. These measures include:

• A careful selection of donors, to exclude those who are at risk of being carriers of infectious diseases,
• Analysis of specific infection markers in individual donations and plasma mixtures,
• The inclusion of stages in the manufacturing process to eliminate/inactivate viruses.

Despite this, when administering blood or plasma-derived medicines, the possibility of transmission of infectious agents cannot be completely ruled out. This also applies to emerging or unknown viruses or other types of infections.

No cases of infections by viruses have been reported with albumin manufactured according to the specifications and processes established in the European Pharmacopoeia.

It is highly recommended that each time healthcare personnel administer a dose ofAlbutein50g/lleave a record of the name of the medicine and batch number administered 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 albumin in children indicates that no adverse effects are to be expected as long as special attention is paid to the dose to avoid circulatory overload.

See also section 4.

Other medicines and Albutein 50 g/l

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine.

No specific complications of human albumin with other medicines have been reported.

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of use of Albutein 50 g/l in women during pregnancy has not been established in controlled clinical trials. Clinical experience with albumin suggests that no adverse effects are to be expected on the course of pregnancy, the fetus or the newborn.

Breastfeeding

The excretion of Albutein 50 g/l in breast milk is unknown. Human albumin has not been studied in animals for excretion in breast milk. The decision to continue or discontinue breastfeeding or to continue or discontinue treatment with Albutein should be made by weighing the benefits of breastfeeding for the baby against the benefits of Albutein therapy for the mother.

Fertility

No studies have been conducted on reproduction in animals with Albutein 50 g/l.

However, human albumin is a normal constituent of human blood.

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery.

Albutein 50 g/l contains sodium

This medicine contains 333.5 mg of sodium (main component of table salt/for cooking) 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%, respectively, of the maximum daily sodium intake recommended for an adult.

This medicine contains less than 39 mg (1 mmol) of potassium per vial/bag, so it is considered essentially "potassium-free".

Albutein 50 g/l is a hospital-use medication, so it will be administered in a hospital by the corresponding healthcare staff.

The dose and infusion rate of Albutein 50 g/l you will receive, as well as the frequency and duration of your treatment, will be adjusted to your individual needs. Your doctor will be responsible for calculating it.

If you use moreAlbutein 50 g/lthan you should

If you have been administered moreAlbutein 50 g/lthan you need, consult your doctorimmediately.

If you forgot to use Albutein 50 g/l

Do not administer a double dose to compensate for a missed dose.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

• Mild reactions such as redness, skin rashes, fever, nausea may appear. These reactions occur rarely.

• Very rarely, severe allergic reactions (anaphylactic shock) may occur.

• For information on viral safety, see section 2.

Other Adverse Effects in Children

No specific data are available to evaluate the possibility of finding different adverse reactions in this population.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD.

Do not store above 30 °C.

Do not freeze.

Store the vial/bag in the outer packaging to protect it from light.

Do not use this medication if you observe that the solution is cloudy or a deposit has formed.

Once the packaging has been opened to be connected to the infusion equipment, the contents must beusedimmediately.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition ofAlbutein 50 g/l

• The active principle 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 components are sodium chloride, sodium caprylate, N-acetyltryptophanate sodium, and water for injection.

Produced from human donor plasma.

For more information on components, see also “Albutein 50 g/l contains sodium” at the end of section 2.

Appearance of the product and contents of the container

Albutein 50 g/l is a solution for infusion. The solution is transparent, slightly viscous, almost colorless, yellow, amber, or green.

Albutein 50 g/l may be presented in:

• Flasks with chlorobutyl rubber stoppers, aluminum caps, plastic caps, and plastic safety seals that ensure the integrity of the container. The flasks contain 100 ml, 250 ml, or 500 ml of product.

-Bags (FlexBag) of polyethylene, with a protective wrapping of polypropylene. The bags contain 100 ml, 250 ml, or 500 ml of product.

Container sizes:

-1 flask with 100 ml, 250 ml, or 500 ml per box.

-1 bag with 100 ml, 250 ml, or 500 ml per box.

Marketing authorization holder and manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - ESPAÑA

This medicinal product is authorized in the member states of the European Economic Areawith the following names:

Germany, Bulgaria, Croatia, Slovakia, Finland, France, Greece, Ireland, Iceland, Poland, Portugal, Czech Republic, Romania, Sweden:Albutein 50 g/l

Denmark, Norway :Albumin Grifols 50 g/l

Italy:Albumina Umana Grifols 50 g/l

Spain :Albutein 50 g/l solution for infusion

Date of the last review of this leaflet:12/2023

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

• Albutein 50 g/l may be administered directly by intravenous route.
• Human albumin should not be mixed with other medications, total blood, or hematocrit concentrates.

• Do not use turbid or sediment-containing solutions. This may indicate that the protein is unstable or that the solution has become contaminated. Once the container is opened, its contents must be used immediately.

• Infusion is carried out by intravenous route, using a single-use, sterile, and apyrogenic infusion set. Before inserting the infusion set into the stopper, it must be disinfected with an appropriate antiseptic. Once the infusion set is attached to the flask, the contents must be infused immediately.

• The infusion rate must be adjusted to individual circumstances and indication. During plasmapheresis, the infusion rate must be adjusted to the exchange rate. If the dose and infusion rate are not adjusted to the patient's circulatory situation, it may cause hypervolemia. In the event of the first clinical signs of circulatory overload (headache, dyspnea, jugular distension, increased blood pressure, or pulmonary edema), the infusion must be interrupted.

• If large volumes are administered, the product must be warmed to ambient or body temperature before use.

• When administering albumin, the patient's electrolyte balance must be monitored and, if necessary, appropriate measures must be taken to restore or maintain it.

• It is necessary to ensure the proper substitution of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
• Unused solutions must be disposed of in accordance with local regulations.

Bag:

• Do not remove the wrapping until use. It may be observed that there is some moisture or condensation on the protective wrapping. This is normal and does not affect the quality or safety of the albumin solution.
• Before administration, check for the absence of small leaks by pressing firmly on the bag. If leaks are detected, discard the solution.
• To connect the infusion set, break the valve by twisting.
• Once the infusion set is attached to the bag, the contents must be infused immediately.
• Do not connect bags in series. This use could produce gas embolism due to air residual extracted from the primary bag before the fluid from the secondary bag is administered.