Albiomin 20% (200 g/l) solucion para perfusion

Product Information for the User

Albiomin 20% (200 g/l), solution for perfusion

Human Albumin

1. What is Albiomin 20% (200 g/l) and what is it used for

2. What you need to know before starting to use Albiomin 20% (200 g/l)

3. How to use Albiomin 20% (200 g/l)

4. Possible adverse effects

5. Storage of Albiomin 20% (200 g/l)

6. Contents of the container and additional information

Albiomin 20% (200g/l) is a perfusion solution (given through a vein). 1liter of solution contains 200g of human plasma protein of which at least 96% is human albumin.

Albiomin 20% (200g/l) is used to restore and maintain circulating blood volume when there is a low blood volume and the use of a colloid, such as albumin, is necessary.

Do not use Albiomin 20% (200g/l)

• if you are allergic to albumin preparations or to any of the other components of this medication (listed in section6).

Warnings and precautions

In case of suspected allergic reactions or anaphylactic reactions, discontinue infusion immediately. In case of shock, follow standard medical guidelines for shock treatment.

Infusion should also be stopped if you develop any of the following signs of cardiovascular overload (hypervolemia):

- Migraine

- Dyspnea (difficulty breathing)

- Jugular vein congestion (accumulation of fluid in a neck vein)

- Increased blood pressure

- Increased venous pressure (increased pressure in veins)

- Pulmonary edema (fluid in the lungs)

Inform your doctor if you have any of the following conditions:

- Heart failure (decompensated heart failure

- High blood pressure (hypertension)

- Dilated veins in the esophagus (esophageal varices)

- Fluid in the lungs (pulmonary edema)

- Abnormal or spontaneous bleeding tendency (diathesis hemorrhagica)

- Severe anemia (reduction of red blood cells)

- Decreased or absent urine production (renal and post-renal anuria)

Your doctor will take the necessary precautions. Your doctor will monitor your circulatory status, electrolyte balance, and blood volume.

Information on the transmission of infectious agents

When administering medications derived from human plasma or blood, certain measures must 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 ruled out entirely. This also applies to emerging or unknown viruses or other types of infections.

No reports of virus transmission with albumin manufactured according to the requirements and processes established in the European Pharmacopoeia have been reported.

It is strongly recommended that each time you are administered a dose of Albiomin 20% (200g/l) you note the name and batch number of the product in order to maintain a record of the batches used.

Use of Albiomin 20% (200g/l) with other medications

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication. Your doctor will decide if Albiomin 20% (200g/l) can be used during pregnancy and breastfeeding.

Driving and operating machinery

Albiomin 20% (200g/l) does not affect your ability to drive and operate machinery.

Albiomin 20% (200g/l) contains sodium

This medication contains approximately 140mg of sodium (main component of table salt/for cooking) in each 50ml vial. This is equivalent to 7.0% of the recommended daily maximum sodium intake for an adult.

This medication contains approximately 280mg of sodium (main component of table salt/for cooking) in each 100ml vial. This is equivalent to 14.0% of the recommended daily maximum sodium intake for an adult.

The treatment with Albiomin 20% (200 g/l) is generally administered in the hospital by a doctor or a nurse.

Human albumin can be administered directly into a vein or diluted in sodium chloride 0.9%.

Dose and administration frequency

The amount of Albiomin 20% (200 g/l) you will receive will depend on your size, the disease, and fluid or protein losses.

Your doctor will establish the amount of Albiomin 20% (200 g/l) and the administration frequency to achieve the correct blood levels.

If you use more Albiomin 20% (200 g/l) than you should

This is very unlikely, but if this happens, your doctor will know what to do.

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

In case of overdose or accidental ingestion, call the Toxicological Information Service immediately, phone 915620420.

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

The following adverse effects have been reported:

• flushing,
• skin eruptions (urticaria),
• fevers and nausea

These occur rarely.

Very rarely, severe reactions such as shock may occur. If this happens, the infusion will be stopped and appropriate treatment will be initiated.

Reporting Adverse Effects

Ifyou experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:http:\\www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about 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 label and on the outer box.

Keep the vialin the outer box to protect it from light.

Do not store at a temperature above25°C.

Do not freeze.

Once opened, the product must be used immediately.

Immediately before administration, check that the solution is transparent. The product should not be used if the solution is cloudy or there are visible particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Albiomin 20% (200g/l)

Each vial of 50ml of solution contains 10g of human plasma protein, of which at least 96% is human albumin.

Each vial of 100ml of solution contains 20g of human plasma protein, of which at least 96% is human albumin.

The othercomponents are sodium caprylate (16mmol/l), sodium chloride (63mmol/l), N-acetyl-tryptophanate (16mmol/l) and water for injection.

Appearance ofAlbiomin 20% (200g/l)and contents of the container

Transparent, slightly viscous liquid; it is practically colorless, yellow, amber or green.

Glass vial with 50ml

Glass vial with 100ml

Holder of the marketing authorization and Responsible for the manufacture

Biotest Pharma GmbH

Landsteinerstraße 5

63303 Dreieich

Germany

Telephone: +49 6103 801-0

Fax: +49 6103 801-150
Email:mail@biotest.com

For more information about this medication, please contact the local representative of the marketing authorization holder:

Grifols Movaco, S.A.

Can Guasc, s/n – Parets del Vallès

08150 Barcelona

Spain

Date of the last review of this leaflet: 05/2020

This information is intended solely for healthcare professionals:

Special warnings and precautions for use

The colloid osmotic effect of human albumin at 200g/l is approximately four times that of blood plasma. Therefore, when administering concentrated albumin, ensure adequate hydration of the patient. Patients should be closely monitored to avoid circulatory overload and hyperhydration.

Albumin solutions should not be diluted with water for injection preparations, as this may cause hemolysis in recipients.

If large volumes need to be replenished, coagulation and hematocrit controls should be performed. Caution should be exercised to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, and red blood cells).

Hypervolemia may occur if the dose and infusion rate are not adjusted to the patient's circulatory status.

No confirmed cases of virus transmission have been reported with albumin manufactured according to the specifications and processes established inthe European Pharmacopoeia.

Interaction with other medications and other forms of interaction

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

Dosage and administration

Dosage

The required dose will be based on the measurement of the circulating volume and not on the determination of albumin plasma levels.

When administering human albumin, the patient's hemodynamic situation should be regularly evaluated; this may include:

- arterial blood pressure and pulse

- central venous pressure

- pulmonary artery occlusion pressure

- diuresis

- electrolytes

- hematocrit/hemoglobin

Administration

Intravenous route.

The solution may be administered directly intravenously, or it may be diluted in an isotonic solution (e.g., sodium chloride 0.9%).

During plasmapheresis, the infusion rate should be adjusted to the exchange rate.

Notes for handling

Albumin solutions should not be diluted with water for injection preparations, as this may cause hemolysis in recipients.

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

The solution should be transparent or slightly opalescent. Do not use solutions that are turbid or have deposits, which may indicate that the protein is unstable or that the solution has become contaminated.

Once the vial has been opened, the contents should be used 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.