Prospect: information for the user

Albuplan 200 g/l, solution for perfusion

Human Albumin

Read this prospect carefully before starting to use this medication, because it contains important information for you.

-Keep this prospect, as you may have to read it again.

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

-This medication has been prescribed only toyou,and you must not give it to other peoplealthough they may have the same symptoms as you, as it may harm them.

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

1. What isAlbuplan200 g/land for what it is used

2. What you need to know before starting to useAlbuplan200 g/l

3. How to useAlbuplan200 g/l

4. Possible adverse effects

5. Storage ofAlbuplan200 g/l

6. Contents of the package and additional information

Albuplan 200 g/l is presented as an intravenous infusion solution containing proteins obtained from human plasma (plasma proteins), which is the liquid part of blood. Each vial contains a solution with 200 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.

Albuplan 200 g/l is used to restore and maintain circulatory volume when a volume deficit has been demonstrated and the use of a colloid is considered appropriate.

If you have any doubts about the use of Albuplan 200 g/l, consult your doctor.

No use Albuplan 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) (see “Important information about some of the components of Albuplan 200 g/l” at the end of this section).

Be especially careful with Albuplan 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, 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.

Information on transmission of infectious agents

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

• A careful selection of donors, excluding 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 medications derived from human blood or plasma, 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 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 Albuplan 200 g/l, they record the name of the medication and batch number administered in order to maintain a record of the batches used.

Use of Albuplan 200 g/l with other medications

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Inform your doctor if you are pregnant or breastfeeding. Your doctor will decide if Albuplan 200 g/l can be used during pregnancy and breastfeeding.

Driving and operating machines

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

Important information about some of the components of Albuplan 200 g/l

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, and 333.5 mg of sodium in each 100 ml vial. This corresponds to 1.7%, 8.3%, and 16.7%, respectively, of the maximum daily sodium intake recommended for an adult. However, depending on the required dose, the patient may receive more than one vial.

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

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

Your doctor will decide, based on your particular condition, the amount of product to be administered, the speed at which it will be administered, the frequency, and the duration of your treatment with Albuplan 200 g/l.

If you use moreAlbuplan 200 g/lthan you should

If you have been administered moreAlbuplan 200 g/l than you should have, consult your doctor or pharmacist immediately.

In case of overdose or accidental administration, consult the Toxicological Information Service. Phone: 91 562 04 20.

If you forgot to use Albuplan 200 g/l

Consult your doctor immediately and follow their instructions. Do not administer a double dose to compensate for the missed doses.

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

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

• Severe allergic reactions (anaphylactic shock) may occur very rarely.

• For information on viral safety, see section 2.

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 25 °C.Do not freeze.

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

The solution must be transparent or slightly opalescent. Do not use this medication if you observe that the solution is cloudy or if a deposit has formed.

Once the packaging has been opened, the contents must be administered immediately.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Albuplan 200 g/l

• The active principle is human albumin. One milliliter ofAlbuplan200 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 preparations.

See section 2 “Important information about one of the components of Albuplan 200 g/l” for additional information about the components.

Appearance of the product and contents of the container

Albuplan200 g/l is asolution for infusion. The solution is transparent, slightly viscous, almost colorless, yellow, amber, or green.

Albuplan 200 g/l is presented in vials containing 10 ml, 50 ml, or 100 ml of product.

Container sizes: 1vial

Holder of the marketing authorization and responsible for manufacturing

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona - SPAIN

Date of the last review of this leaflet:June 2019

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

This information is intended solely for healthcare professionals:

• Albuplan200 g/l should be administered intravenously, infusing the contents of the container directly, or diluted with an isotonic solution (e.g., 5% glucose solution or physiological saline solution). The mixing with electrolyte solutions should be performed in aseptic conditions.

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

• Human albumin should not be mixed with other medications, total blood, or hematocrit concentrates.

• Solutions should be transparent or slightly opalescent. Do not use solutions that are turbid or have sediments, as it may indicate that the protein is unstable or that the solution has been contaminated. Once the container is opened, its contents should be used immediately.

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

• The infusion rate should be adjusted according to the specific circumstances of each case and the indication. During plasmapheresis, the infusion rate should 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 presence of the first clinical signs of circulatory overload (headache, dyspnea, jugular distension, increased blood pressure, or pulmonary edema), the infusion should be interrupted.

• If significant volumes are administered, the product should be brought to room temperature or body temperature before use.

• When administering concentrated albumin, it is essential to ensure that the patient has adequate hydration. Patients should be adequately monitored to prevent circulatory overload and hyperhydration.

• When administering albumin, the patient's electrolyte balance should be monitored, and if necessary, appropriate measures should 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).

Unused solutions should be disposed of properly.