Albutein 50 g/L solution for infusion

Package leaflet: Information for the user

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, 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Albutein 50 g/l
6. 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 an intravenous infusion solution containing proteins derived 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 medicine 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 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 using Albutein 50 g/l

Do not use Albutein 50 g/l

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Albutein 50 g/l. Exercise special caution with Albutein 50 g/l

• If you are at special risk due to an increased blood volume, for example, in cases of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, coagulation disorders, severe reduction in red blood cells, or absence of urine production.
• If signs of increased blood volume occur (headache, breathing difficulties, jugular vein distension), or increased blood pressure. The infusion must be stopped immediately.
• If signs of an allergic reaction occur. The infusion must be stopped immediately.
• When used in patients with severe traumatic brain injury.

When medicines derived from human plasma or blood are administered, certain measures are taken to prevent transmission of infections to patients. These measures include:

• careful selection of donors to exclude those at risk of carrying infectious diseases,
• testing for specific infection markers in individual donations and plasma pools,
• inclusion of manufacturing steps designed to eliminate and/or inactivate viruses.

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

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

It is highly recommended that each time healthcare personnel administer a dose of Albutein 50 g/l, the name of the medicine and the batch number administered be recorded, in order to maintain traceability of the batches used.

Children

The safety and efficacy of Albutein 50 g/l have not been established in children in controlled clinical trials. However, clinical experience with albumin in children indicates that harmful effects are not expected, provided special attention is paid to dosing in order to avoid circulatory overload.

See also section 4.

Other medicines and Albutein 50 g/l

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 are planning to become pregnant, consult your 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. Clinical experience with albumin suggests that harmful effects on the course of pregnancy, the fetus, or the newborn are not expected.

Breastfeeding

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

Fertility

No animal reproduction studies have been conducted with Albutein 50 g/l.

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

Driving and use of machines

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

Albutein 50 g/l contains sodium

This medicine contains 333.5 mg of sodium (the main component of table/cooking 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 and is therefore considered essentially “potassium-free”.

3. How to use Albutein 50 g/l

Albutein 50 g/l is a hospital-use medicine, therefore it will be administered to you in a hospital by qualified healthcare personnel.

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 determine this accordingly.

If you use more Albutein 50 g/l than you should

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

If you forget to use Albutein 50 g/l

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

• Mild reactions such as redness, skin rashes, fever, nausea may occur. Such reactions are rare.

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

• For information on viral safety, see section 2.

Other adverse effects in children

There are no specific data available to assess the likelihood of different adverse reactions occurring in this population.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the container after EXP.

Do not store above 30 °C.

Do not freeze.

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

Do not use this medicine if you notice that the solution is cloudy or if any precipitate has formed.

Once the container has been opened for connection to the infusion apparatus, the contents should be used immediately.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Albutein 50 g/l

• 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.

• The other components are sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, and water for injections.

Manufactured from plasma from human donors.

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

Nature of the product and contents of the container

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

Albutein 50 g/l may be supplied in:

• Vials with a chlorobutyl rubber stopper, aluminium cap, plastic cover, and plastic security seal ensuring the integrity of the container. The vials contain 100 ml, 250 ml, or 500 ml of product.

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

Pack sizes:

• 1 vial containing 100 ml, 250 ml, or 500 ml per carton.
• 1 bag containing 100 ml, 250 ml, or 500 ml per carton.

Marketing Authorisation Holder and Manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This medicinal product is authorised in the European Economic Area (EEA) Member States 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 the most recent revision of this leaflet: 12/2023

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

This information is intended for healthcare professionals only:

• Albutein 50 g/l may be administered directly by intravenous route.

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

• Do not use solutions that are cloudy or contain precipitates. This may indicate protein instability or contamination of the solution. Once the container has been opened, its contents must be used immediately.

• Infusion is performed intravenously using a single-use, sterile, pyrogen-free infusion set. Before inserting the infusion set into the stopper, it must be disinfected with an appropriate antiseptic. Once the infusion set is connected to the vial, the contents must be infused immediately.

• The infusion rate must be adjusted according 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 status, hypervolaemia may occur. In the event of early clinical signs of circulatory overload (headache, dyspnoea, jugular distension), increased blood pressure, increased venous pressure, or pulmonary oedema, the infusion must be stopped.

• When 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 appropriate measures must be taken, if necessary, to restore or maintain it.

• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes) must be ensured.

• Unused solutions must be disposed of in accordance with local regulations.

Bag:

• Do not remove the overwrap until use. Some moisture or condensation on the protective overwrap may be observed. This is normal and does not affect the quality or safety of the albumin solution.
• Before administration, check for 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. This use could lead to gas embolism due to residual air being drawn from the primary bag before completion of fluid administration from the secondary bag.