ALBUTEIN 200 G/L SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Albutein 200 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 experience 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 200 g/l and what is it used for
2. What you need to know before you use Albutein 200 g/l
3. How to use Albutein 200 g/l
4. Possible side effects
5. Storage of Albutein 200 g/l
6. Contents of the pack and further information

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

Albutein 200 g/l is a solution for intravenous infusion that contains proteins obtained from human plasma (plasma proteins), which is the liquid part of the blood. Each vial/bottle/bag contains a solution with 200 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 200 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 questions about the use of Albutein 200 g/l, ask your doctor.

2. What you need to know before you use Albutein 200 g/l

Do not 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

Talk to your doctor, pharmacist, or nurse before you start using Albutein 200 g/l.

Be especially careful with Albutein 200 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 head 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. These 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,
• 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 200 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 200 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 200 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, breast-feeding, and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The safety of using Albutein 200 g/l in pregnant women 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.

Breast-feeding

It is not known whether Albutein 200 g/l is excreted in breast milk. The excretion of human albumin in breast milk has not been studied in animals. The decision to continue or stop breast-feeding or to continue or stop treatment with Albutein should be made by weighing the benefit of breast-feeding to the baby against the benefit of therapy with Albutein for the mother.

Fertility

No reproduction studies have been performed with Albutein 200 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 200 g/l contains sodium

This medicine contains 33.4 mg of sodium (a major component of table salt/cooking 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%, respectively, of the maximum daily sodium intake recommended for an adult.

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

3. How to use Albutein 200 g/l

Albutein 200 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 200 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 more Albutein 200 g/l than you should

If you have been given more Albutein 200 g/l than you need, talk to your doctor immediately.

If you forget to use Albutein 200 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, 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 200 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/bottle/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 pack is opened for connection 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 further information

Composition of Albutein 200 g/l

• 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 donations.

For more information on the ingredients, see also "Albutein 200 g/l contains sodium" at the end of section 2.

Appearance of the product and pack contents

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 can be presented in:

• Vials/bottles with a rubber stopper, aluminum cap, plastic cover, and plastic security seal that guarantee the integrity of the pack. The vials contain 10 ml of product and the bottles contain 50 ml or 100 ml of product.

• Bags (FlexBag) of polyethylene, with a protective wrapper of polypropylene. The bags contain 50 ml or 100 ml of product.

Pack sizes:

• 1 vial with 10 ml per box
• 1 bottle with 50 ml or 100 ml per box
• 1 bag with 50 ml or 100 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 200 g/l

Denmark, Norway: Albumin Grifols 200 g/l

Italy: Albumina Umana Grifols 200 g/l

Spain: Albutein 200 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 200 g/l can be administered directly by intravenous route, or it can be diluted in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution). The mixture with electrolyte solutions must be performed under aseptic conditions.

• Albumin solutions must not be diluted with water for injections, as this may cause hemolysis in the recipient.

• Human albumin must not be mixed with other medicines, whole blood, or red blood cell concentrates.

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

• The infusion is performed intravenously, with a single-use infusion set, sterile and apyrogenic. 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/bottle, 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 vein 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 ambient or body temperature before use.

• The 200 g/l albumin solution has a corresponding hyperoncotic effect. When concentrated albumin is administered, it must be ensured that the patient has adequate hydration.
• Patient monitoring is required to avoid circulatory overload and hyperhydration.
• When administering albumin, the patient's electrolyte balance must be monitored, and appropriate measures must be taken to restore or maintain it if necessary.

• 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.