Package Leaflet: Information for the User

Albutein 200 g/l solution for infusion

human albumin

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

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

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

-This medicine has been prescribed for youonly,and you must 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 200 g/l is and what it is used for

2. What you need to know before using 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 additional information

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 blood.Each vial/bottle/bag contains a solution with200 gof 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 200 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 200 g/l, consult your doctor.

No use Albutein 200 g/l

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use 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 cases 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 medications, certain measures are taken to prevent the transmission of infections to patients. These measures include:

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

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

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

It is highly recommended that each time healthcare personnel administer a dose of Albutein 200 g/l, they record the name of the medication and batch number administered 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 adverse effects are expected as long as special attention is paid to the dose to avoid circulatory overload.

See also section 4.

Other medications and Albutein 200 g/l

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

No specific complications of human albumin with other medications 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 medication.

The safety of using Albutein 200 g/l in women during pregnancy has not been established in controlled clinical trials. Clinical experience with albumin suggests that no adverse effects are expected on the course of pregnancy, the fetus, or the newborn.

Breastfeeding

It is unknown whether Albutein 200 g/l is excreted in breast milk. Human albumin has not been studied in animals for excretion in breast milk. The decision to continue or discontinue breastfeeding or 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 200 g/l.

However, human albumin is a normal constituent of human blood

Driving and operating machinery

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

Albutein 200 g/l contains sodium

This medication contains 33.4 mg of sodium (main component of table salt/for cooking) in each 10 ml vial, 166.8 mg of sodium in each 50 ml vial/bag, and 333.5 mg of sodium in each 100 ml vial/bag. This corresponds to 1.7%, 8.3%, and 16.7%, respectively, of the maximum daily sodium intake recommended for an adult.

This medication contains less than 39 mg (1 mmol) of potassium per vial/bag, making it essentially "potassium-free".

Albutein 200 g/l is a hospital-use medication, and it will be administered in a hospital by the corresponding healthcare personnel.

The dose and infusion rate of Albutein 200 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 200 g/lthan you should

If you have been administered moreAlbutein 200 g/lthan you need, consult your doctorimmediately.

If you forgot to use Albutein 200 g/l

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

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

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

• Severe allergic reactions (anaphylactic shock) may rarely 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 not listed 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.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.

Do not store at a temperature above 30 °C.Do not freeze.

Store the vial/bottle/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 be used immediately.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition ofAlbutein 200 g/l

• The active ingredient is human albumin. One milliliter of Albutein200 g/l contains 200 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 200 g/l contains sodium” at the end of section 2.

Appearance of the product and contents of the container

Albutein200 g/l is aperfusion solution. The solution is transparent, slightly viscous, almost colorless, yellow, amber, or green.

Albutein 200 g/l may be presented in:

• Amber glass vials/bottles with chlorobutyl rubber stopper, aluminum cap, plastic cap, and plastic safety sealthatguarantee the integrity of the container. The vialscontain 10 mlof product and the bottles contain50 ml or 100 ml of product.

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

Container 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 responsible

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This medicinal product is authorized in the member states of the European Economic Area with 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 perfusion solution

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:

• Albutein200 g/l may be administered directly by intravenous route, or it may be diluted in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution). The mixing with electrolyte solutions must be performed in aseptic conditions.

• Albumin solutions must not be diluted with water for injection, as it may cause hemolysis in the recipient of the product.

• Human albumin must not be mixed with other medications, whole 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 been contaminated. Once the container is opened, its contents must be used immediately.

• The infusion is performed 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 coupled 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 exchange rate. If the dose and infusion rate are not adjusted to the patient's circulatory situation, it may cause circulatory overload. 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 room temperature or body temperature before use.

• The 200 g/l albumin solution has a corresponding hyperosmotic effect. When administering concentrated albumin, ensure that the patient is adequately hydrated.
• Patients must be adequately monitored to prevent circulatory overload and overhydration.
• When administering albumin, the patient's electrolyte balance must be controlled and, if necessary, appropriate measures must be taken to restore or maintain it.

• It is necessary to ensure the adequate substitution of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).

The unused solutions must be disposed of in accordance with local regulations.

Bag:

• Do not remove the wrapper until use. It may be observed that there is some humidity or condensation on 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 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 coupled to the bag, the contents must be infused immediately.
• Do not connect bags in series. This use may cause gas embolism due to air residual extracted from the primary bag before the fluid from the secondary bag is administered.