Biseko

Package Leaflet: Information for the User

Biseko, 50 mg/ml, Solution for Infusion

Human Serum Protein

Please read carefully the contents of this leaflet before using the medicine, as it contains important information for the patient.

Information important for the patient.

• Please keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Biseko and what is it used for
• 2. Important information before using Biseko
• 3. How to use Biseko
• 4. Possible side effects
• 5. How to store Biseko
• 6. Contents of the pack and other information

1. What is Biseko and what is it used for

Biseko is a solution for intravenous infusion or injection and is used

• for volume replacement therapy (hypovolemia)
• in cases of decreased protein levels in the blood (hypoproteinemia)
• in cases of decreased gamma-globulin levels in the blood (hypogammaglobulinemia)
• in cases of decreased albumin levels in the blood (hypoalbuminemia)
• for the prevention of infectious diseases in cases of antibody deficiency (antibody deficiency syndrome)
• for blood dilution (hemodilution).

2. Important information before using Biseko

When not to use Biseko

• if the patient is allergicto human serum proteins or any other component of this medicine (listed in section 6).
• if the patient has hypersensitivity to human immunoglobulin, particularly in very rare cases of IgA deficiency and the presence of anti-IgA antibodies.

Warnings and precautions

Before starting treatment with Biseko, discuss it with your doctor or pharmacist

• if the patient has previously experienced intolerance reactionsduring the use of infusion solutions containing human serum proteins.
• if the patient needs to control sodium/salt or potassium intake in their dietor has kidney function disorders. In such cases, inform your doctor and pay attention to the section "Biseko contains sodium and potassium".

Some serious side effects may be caused by the infusion rate. You should
follow the recommended infusion rate described in section 3 "How to use Biseko" and during the entire
infusion period, monitor patients and observe for signs of side effects. Observation should be continued for at least 20 minutes after
administration.
In case of intolerance reactions, reduce the infusion rate or interrupt the infusion until symptoms resolve.
If after interrupting the infusion, intolerance reactions persist, apply appropriate treatment.
Anaphylactic shock is rare, but always life-threatening. In case of shock, apply current standard medical treatment for shock.

Information on infectious agent transmission

Biseko is produced from human plasma (the liquid part of the blood). When medicines are produced from human blood or plasma, precautions must be taken to prevent the transmission of infections to patients through the administration of such medicines. All blood donors are tested for the presence of viruses and infectious diseases. For medicines produced from human blood or plasma, manufacturers take steps to inactivate or remove viruses.
Despite these precautions, it cannot be completely ruled out that the transmission of infectious agents may occur during the administration of products derived from human blood or plasma.
These measures are considered effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The effectiveness of these measures may be limited for non-enveloped viruses, such as hepatitis A virus (HAV) and parvovirus B19.
Parvovirus B19 infection can be serious for pregnant women (fetal infection) and patients with weakened immune systems or with certain types of anemia (e.g., sickle cell anemia or hemolytic anemia).
It is strongly recommended that during each administration of Biseko to a patient, the name and batch number of the medicine be recorded in order to document which batches were used and to determine which batch the patient received.

Biseko and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Vaccines containing live, attenuated viruses: Administration of immunoglobulins may weaken the

for at least6 weeks to 3 months the effectiveness of live, attenuated virus vaccines against viral diseases, such as measles, rubella, mumps, and
chickenpox. In the case of measles, this period may last up to 1 year. Therefore, it is recommended to determine the antibody titer in patients vaccinated against measles.
Laboratory tests:After administration of Biseko, a transient increase in the level of various passively transferred antibodies in the patient's blood may occur, which may cause false-positive results in serological tests. This is due to the transfer of antibodies (passive immunization) and should be taken into account by the doctor.
Hint:
Biseko can be mixed with a physiological saline solution. However, Biseko solution should not be mixed with other products, as changes in electrolyte concentration or pH value may lead to precipitation or denaturation of proteins.
Biseko is suitable for preparing a suspension with erythrocyte concentrates.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The safety of using this medicine in pregnant women has not been evaluated in controlled clinical trials. Therefore, it should be used in pregnant and breastfeeding women with caution.
Clinical observations related to the administration of Biseko indicate that no harmful effects on the course of pregnancy, the fetus, or the newborn are expected.
Immunoglobulins are excreted into breast milk, which may contribute to an increase in antibody titers in the newborn.

Driving and using machines

Biseko has no influence on the ability to drive and use machines.

Biseko contains sodium and potassium

1 vial of 20 ml contains 3.1 mmol (71.2 mg) of sodium
1 vial of 50 ml contains 7.8 mmol (178 mg) of sodium
1 vial of 250 ml contains 38.8 mmol (890 mg) of sodium
1 vial of 500 ml contains 77.5 mmol (1780 mg) of sodium
This should be taken into account in patients controlling their sodium intake.
1 vial of 20 ml and 1 vial of 50 ml contain potassium, but in an amount less than 1 mmol (39 mg), which allows the medicine to be considered "potassium-free".
1 vial of 250 ml contains 1 mmol (40 mg) of potassium, 1 vial of 500 ml contains 2 mmol (80 mg) of potassium. This should be taken into account in patients with kidney function disorders and in patients controlling their potassium intake.

3. How to use Biseko

Biseko is administered by a doctor. Recommended dose:
Adults: up to 2000 ml per patient and per day
Children and adolescents: 15-20 ml/kg body weight and per day
Biseko is intended for intravenous administration. The medicine should be warmed to room temperature or body temperature before administration. The medicine should be visually inspected before use.
Do not use if the solution is cloudy or contains sediment.
During intravenous infusion, initially administer 20 drops (1 ml) per kilogram of body weight per hour, after 10 minutes, the infusion rate can be gradually increased to a maximum of 4 ml per kilogram of body weight per hour, and in case of good tolerance by the patient, maintain this infusion rate until the end of the infusion.
The attending doctor decides on the frequency and duration of administration.

Use of a higher dose of Biseko than recommended

In newborns and infants receiving Biseko in a dose higher than the maximum recommended, which corresponds to the approximate circulating volume or larger, it cannot be ruled out that side effects may occur. Consult a doctor if you think the child has received too much Biseko.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Biseko can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people)

• Headache
• Nausea, vomiting
• Joint pain and mild back pain
• Chills, fever
• Allergic reactions

Rare (may affect up to 1 in 1,000 people)

• Decrease in blood pressure
• Severe, life-threatening allergic reaction (anaphylactic shock), even if the patient did not show an allergic reaction during previous uses.

In newborns and infants receiving Biseko in a dose higher than the maximum recommended, which corresponds to the approximate circulating volume or larger, it is possible that even with very low isoagglutinin content, clinical symptoms may occur. Pay attention to increased hemolysis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Biseko

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "Expiry date".
Store in a refrigerator (2°C – 8°C).
Store in the original package to protect from light.
Do not freeze.
Do not use Biseko if the solution is cloudy or contains sediment.
The infusion solution should be administered immediately after opening the container. Unused solution should be discarded due to the risk of bacterial contamination.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Biseko contains

The active substance is: Human Serum Protein.
1000 ml of the infusion solution contains 50 g of human serum protein,
including approximately 31 g of albumin and approximately 10 g of human immunoglobulin, including: approximately 7.0 g of immunoglobulin G, approximately 1.4 g of immunoglobulin A, and approximately 0.5 g of immunoglobulin M.
Other ingredients are: sodium ions, potassium ions, calcium ions, magnesium ions, chloride ions, water for injections.

What Biseko looks like and contents of the pack

Biseko is a clear or slightly opalescent and brownish-yellow solution in a vial and in glass vials.
Biseko is available in the following pack sizes:
Pack containing one vial of 20 ml (1 g)
Pack containing one vial of 50 ml (2.5 g)
Pack containing one vial of 250 ml (12.5 g)
Pack containing one vial of 500 ml (25 g)

Marketing Authorisation Holder and Manufacturer

Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: +49 6103 801-0
Fax: +49 6103 801-150
Email: [email protected]

Date of last revision of the leaflet: