ALBUTEIN 50 G/L SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Albutein 50 g/l Solution for Infusion

Human Albumin

Read all of this leaflet carefully before you start using this medicine 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 is Albutein 50 g/l and what is it used for
2. What you need to know before you use 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 other information

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

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

This medicine belongs to a group of medicines called plasma substitutes and plasma protein fractions.

Albutein 50 g/l is used to restore and maintain 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.

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

Do not useAlbutein 50 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

Consult your doctor, pharmacist, or nurse before starting to use Albutein 50 g/l. Be particularly 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, arterial hypertension, dilated veins in the esophagus, fluid in the lungs, coagulation disorders, severe decrease in red blood cells 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 medicines derived from human plasma or blood, certain measures are taken to prevent the transmission of infections to patients. Such measures include:

• 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 in plasma pools,
• the inclusion of stages in the manufacturing process to eliminate/inactivate viruses.

Despite this, when administering medicines derived from human blood or plasma, the possibility of transmitting infectious agents cannot be completely excluded. This also applies to emerging or unknown viruses or other types of infections.

No cases of viral infections 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 of Albutein 50 g/l, they record 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 harmful 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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No specific complications of human albumin with other medicines are known.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

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

Breastfeeding

It is not known whether Albutein 50 g/l is excreted in breast milk. Excretion of human albumin into breast milk has not been studied in animals. The decision to continue or stop breastfeeding or to continue or stop treatment with Albutein should be made by weighing the benefit of breastfeeding to the baby against the benefit of therapy with Albutein for the mother.

Fertility

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

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

Driving and using machines

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

Albutein 50 g/l contains sodium

This medicine contains 333.5 mg of sodium (main component of cooking/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%, 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".

3. How to use Albutein 50 g/l

Albutein 50 g/l is a hospital medicine, so it will be administered to you in a hospital by the corresponding healthcare personnel.

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

If you use moreAlbutein 50 g/lthan you should

If you have been administered more Albutein 50 g/l than you need, consult your doctor immediately.

If you forget to use Albutein 50 g/l

You should not be given a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Mild reactions such as flushing, skin rash, fever, nausea may occur. Such reactions are rare.

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

• For information on viral safety, see section 2.

Other side effects in children

There are no specific data to assess the possibility of finding different adverse reactions in this population.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Albutein 50 g/l

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

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 medicine if you notice that the solution is turbid or that a deposit has formed.

Once the packaging is opened to be connected to the infusion equipment, the contents must 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

Composition ofAlbutein 50 g/l

• 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 donations.

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

Appearance and packaging of the product

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 can be presented in:

• Vials with a rubber stopper, aluminum cap, plastic cover, and plastic security seal that guarantee the integrity of the packaging. The vials contain 100 ml, 250 ml, or 500 ml of product.

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

Package sizes:

• 1 vial of 100 ml, 250 ml, or 500 ml per box.
• 1 bag of 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 - SPAIN

This medicine is authorized in the Member States of the European Economic Area under 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 last revision of this leaflet:12/2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

• Albutein 50 g/l can be administered directly by intravenous route.
• Human albumin should not be mixed with other medicines, whole blood, or red blood cell concentrates.

• Turbid or sediment-containing solutions should not be used. This may indicate that the protein is unstable or that the solution has been contaminated. Once the packaging is opened, its contents must be used immediately.

• The infusion is carried out by intravenous route, with a single-use, sterile, and apyrogenic infusion set. Before inserting the infusion set into the stopper, it must be disinfected with a suitable antiseptic. Once the infusion set is connected to the vial, 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 replacement rate. If the dose and infusion rate are not adjusted to the patient's circulatory situation, hypervolemia may occur. In the event of the first clinical signs of circulatory overload (headache, dyspnea, jugular congestion), increased blood pressure, or increased venous pressure and pulmonary edema, the infusion must be interrupted.

• If large volumes are administered, the product must be warmed to room 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.

• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and red blood cells) must be ensured.
• Solutions that have not been used must be disposed of in accordance with local regulations.

Bag:

• Do not remove the wrapper until use. Some moisture or condensation may be observed in the protective wrapper. 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 firmly pressing the bag. If leaks are detected, discard the solution.

• To connect the infusion set, break the valve by twisting.

• Once the infusion set is connected to the bag, the contents must be infused immediately.

• Do not connect bags in series. Such use could produce gas embolisms due to residual air extracted from the primary bag before the fluid administration from the secondary bag is completed.