Human Albumin Grifols 20%

PATIENT INFORMATION LEAFLET: USER INFORMATION

Human Albumin Grifols 20%, 200 g/l, solution for infusion

Human Albumin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Human Albumin Grifols 20% and what is it used for
• 2. Important information before using Human Albumin Grifols 20%
• 3. How to use Human Albumin Grifols 20%
• 4. Possible side effects
• 5. How to store Human Albumin Grifols 20%
• 6. Package contents and other information

1. What is Human Albumin Grifols 20% and what is it used for

Human Albumin Grifols 20% is a solution for infusion. It contains proteins obtained from human plasma, which is the liquid part of the blood. More than 95% of the plasma protein contained in this product is human albumin at a concentration of 20% weight per volume. Human Albumin Grifols 20% belongs to a group of medicines called plasma substitutes and plasma protein fractions. Human Albumin Grifols 20% is used to: supplement and maintain blood volume in conditions where blood volume is too low and plasma substitution is indicated. If you have any questions about Human Albumin Grifols 20%, ask your doctor.

2. Important information before using Human Albumin Grifols 20%

When not to use Human Albumin Grifols 20%:

- If you are allergic (hypersensitive) to human albumin or any of the other ingredients of Human Albumin Grifols 20% (listed in section 6) (see "Important information about the ingredients of Human Albumin Grifols 20%" at the end of this chapter).

Warnings and precautions

Before starting treatment with Human Albumin Grifols 20%, discuss it with your doctor, pharmacist, or nurse. Infusion should be stopped immediately if you experience symptoms of an allergic reaction with breathing difficulties, weakness, or other symptoms. If you are aware of any of the following conditions or diseases, you should inform your doctor: heart problems, high blood pressure, esophageal varices (inflammation of the veins of the esophagus), pulmonary edema (fluid accumulation in the lungs), thrombotic or bleeding disorders, severe anemia, urinary disorders. The presence of these conditions or diseases may exclude you from treatment with Human Albumin Grifols 20% or lead your doctor to change the dose/speed of infusion. To avoid potential infections resulting from the administration of products obtained from human blood or plasma, precautions include: donor selection to eliminate those who suffer from infectious diseases, screening tests for individual blood donations and whole plasma pools for specific virus/infectious disease markers, and the use of effective virus inactivation/removal procedures during the processing of blood or plasma. Despite these precautions, when blood products are administered, it is not possible to completely exclude the risk of transmission of infectious agents, including unknown viruses or other types of infections.

There are no confirmed reports of virus transmission with albumin preparations produced using an approved process, in accordance with the specifications given in the European Pharmacopoeia. It is strongly recommended to record the name and batch number of the product each time Human Albumin Grifols 20% is administered to a patient, in order to ensure that the product with a given name and batch can be traced to the patient being treated.

Human Albumin Grifols 20% and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use. No specific interactions of this product with other medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Important information about the ingredients of Human Albumin Grifols 20%

The product contains 1.5 mmol (33.4 mg) of sodium per 10 ml vial, 7.3 mmol (166.8 mg) of sodium per 50 ml bottle, and 14.5 mmol (333.5 mg) of sodium per 100 ml bottle. This should be taken into account for patients on a low-sodium diet. The product contains less than 1 mmol (39 mg) of potassium per vial, i.e., it is essentially potassium-free.

3. How to use Human Albumin Grifols 20%

Human Albumin Grifols 20% is a medicine intended for hospital use only. It is administered by intravenous infusion by medical personnel and cannot be administered by the patient themselves. The strength of the albumin preparation, dose, and infusion rate, as well as the frequency of administration and duration of treatment, will be adjusted according to the individual patient's condition. This will be decided by your doctor.

In case of overdose of Human Albumin Grifols 20%

Administration of too high a dose or too rapid infusion may lead to excessive increase in blood volume (hypervolemia). If the first symptoms of overdose appear, the infusion will be stopped immediately by medical personnel.

Missed dose of Human Albumin Grifols 20%

Inform your doctor or pharmacist immediately and follow their instructions. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Human Albumin Grifols 20% can cause side effects, although not everybody gets them. Contact your doctor if you experience the following side effects:

• Severe allergic reactions such as anaphylactic shock may occur very rarely. In such cases, the infusion should be stopped immediately and appropriate treatment started.
• Mild reactions such as:
• redness
• skin rash (hives)
• fever
• nausea

These mild reactions may occur rarely and usually disappear quickly after slowing down or stopping the infusion. Information on virus safety - see section 2.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Human Albumin Grifols 20%

Keep the medicine out of the sight and reach of children. Do not use the medicine after the expiry date stated on the label and carton. Store below 25°C. Do not freeze. To protect from light, store in the original packaging. The solution should be clear to slightly opalescent. Do not use this medicine if the solution is cloudy or has sediment at the bottom. Use immediately after opening. Do not throw away in the sink or toilet. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Human Albumin Grifols 20% contains

Active substance: Human Albumin. 1 liter of Human Albumin Grifols 20% contains 200 g of protein, of which at least 95% is human albumin. Other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophan, water for injections. The solution contains from 130 to 160 mmol/l of sodium and no more than 2 mmol/l of potassium. For more information on the ingredients of the medicine, see "Important information about the ingredients of Human Albumin Grifols 20%" at the end of section 2.

What Human Albumin Grifols 20% looks like and contents of the pack

Human Albumin Grifols 20% is a solution for infusion. Clear, slightly viscous liquid: it is almost colorless, slightly yellow, slightly amber, or slightly green. Available packages: Human Albumin Grifols 20%, 1 vial of 10 ml, 1 bottle of 50 ml, and 1 bottle of 100 ml. Packaging of 1 bottle.

Marketing authorization holder and manufacturer

INSTITUTO GRIFOLS, S.A. Poligono Levante, c/Can Guasch, 2 08150 Parets del Vallès, Barcelona, SPAIN For more detailed information, please contact the representative of the marketing authorization holder. Grifols Polska Sp. z o. o. Ul. Grzybowska 87 00-844 Warsaw Tel: +48 22 378 85 61

Date of revision of the leaflet: