Package Insert: Information for the User

Plasbumin20% Solution for Infusion

Human Albumin 20%

This medication belongs to a group of medications called plasma substitutes.

It is presented as an intravenous infusion solution. Each package of Plasbumin 20 contains 1 vial with human albumin.

The administration of Plasbumin 20 is indicated for the restoration and maintenance of circulating volume when a volume deficit has been demonstrated and the use of a colloid is considered appropriate. The choice of albumin over an artificial colloid will depend on the patient's clinical situation and will be based on official recommendations.

No use Plasbumin 20:

If you are allergic (hypersensitive) to albumin 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 Plasbumin 20

Inform your doctor if:

• You have an allergic reaction or anaphylaxis, as the infusion should be immediately discontinued. In case of hypersensitivity to human plasma proteins, administration will be carried out slowly, taking special precautions and under medical supervision.
• You have:

-Decompensated heart failure

-Hypertension

-Esophageal varices

-Pulmonary edema

-Bleeding diathesis

-Severe anemia

-Renal and postrenal anuria

This medication should be administered with caution as it may cause hypervolemia (abnormal increase in plasma volume) or hemodilution.

When administering medications derived from plasma or human blood, certain measures should be 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 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 caused by viruses 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 ofPlasbumin 20they record the name of the medication and batch number administered in order to maintain a record of the batches used.

Use of Plasbumin 20 with other medications

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

Generally, this medication should not be mixed with other medications, including whole blood and red blood cell concentrates.

Pregnancy, breastfeeding, and fertility

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.

Your doctor will weigh the potential risk to the fetus and inform you if treatment with this medication is appropriate.

Driving and operating machinery

There is no indication that Plasbumin 20 may affect your ability to drive vehicles or operate machinery.

Important information about one of the components of Plasbumin 20

Patients with low-sodium diets should note that this medication contains 166.8 mg (7.3 mmol) of sodium per 50 ml vial and 333.5 mg (14.5 mmol) of sodium per 100 ml vial..

Patients with renal insufficiency or low-potassium diets should note that this medication contains a maximum of 10 mmol of potassium per liter of infusion solution.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Plasbumin 20 is a hospital-use medication, so it will be administered to you in a hospital by the corresponding healthcare staff.

The concentration and dose of albumin and the speed at which it will be administered will be adjusted to your needs.

Your doctor will indicate how often and at what intervals Plasbumin 20 should be administered.

Your doctor will indicate the duration of your treatment with Plasbumin 20.

If you use more Plasbumin 20 than you should

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 Plasbumin 20

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

• Rare adverse effects (occurring at a rate of 1 to 10 in every 10,000 patients treated): mild reactions such as redness, skin rashes, fever, and nausea may appear.
• Very rare adverse effects (occurring in fewer than 1 in 10,000 treated patients): anaphylactic shock may occur.

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.

Keep in its original packaging and protected from light.Do not store at a temperature above30°C.

Do not freeze.

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

The expiration date is the last day of the month indicated

Once the packaging is opened, its contents must be used immediately.

Do not use this medication if you observe that the solution is cloudy or has sediment.

Composition of Plasbumin 20

- The active principle is human albumin.

Each vial contains a 20% protein solution, of which at least 95% is human albumin.

• The other components are: sodium caprylate, N-acetyl-DL-tryptophan, ions (sodium, potassium) and water for injections.

For more information on the components, see also “Important information about one of the components of Plasbumin 20” at the end of section 2.

Appearance of the product and contents of the package

Plasbumin 20 is presented as a perfusion solution intravenously . The solution is clear, slightly viscous, pale yellow to amber or green .

Plasbumin 20 is presented in vials containing 50 ml and 100 ml of product.

Package size: 1 vial

Holder of marketing authorization and responsible for manufacturing

Holder of marketing authorization

Grifols Deutschland GmbH

Colmarer Stra ße 22

D-60528 Frankfurt

Germany

Responsible for manufacturing

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Local Representative

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Last review date of this leaflet: December 2016

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

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This information is intended solely for medical professionals or healthcare professionals:

• Plasbumin 20 must be administered intravenously, perfusing the contents of the vial directly, or diluted with an isotonic solution (e.g. 5% glucose solution or physiological saline solution). The mixture with electrolyte solutions must be performed in aseptic conditions.
• Plasbumin 20 must not be diluted with water for injections, as it may cause hemolysis in the recipient of the product.
• Solutions must be clear or slightly opalescent. Do not use turbid or sediment-containing solutions, as this may indicate that the protein is unstable or that the solution has become contaminated. Once the vial has been opened, its contents must be used immediately.
• The infusion is carried out intravenously, 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 has been connected to the vial, the contents must be infused immediately.
• The infusion rate must be adjusted according to the specific circumstances of each case and the indication. During plasma exchange, the infusion rate must be adjusted to the exchange rate. If the dose and infusion rate have not been adjusted to the patient's circulatory situation, it may cause hypervolemia. In the event of the first clinical signs of cardiovascular 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 brought to body temperature before use.
• When administering concentrated albumin, ensure that the patient has adequate hydration. Patients must be adequately monitored to prevent circulatory overload and hyperhydration.
• 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 red blood cells).

Unused solutions must be disposed of properly.