Flexbumin 200 g/l

Package Leaflet: Information for the User

Flexbumin 200 g/l, Solution for Infusion

Human Albumin

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

• Keep this package 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 any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 1. What is Flexbumin 200 g/l and what is it used for
• 2. Important information before using Flexbumin 200 g/l
• 3. How to use Flexbumin 200 g/l
• 4. Possible side effects
• 5. How to store Flexbumin 200 g/l
• 6. Contents of the pack and other information

1. What is Flexbumin 200 g/l and what is it used for

Flexbumin 200 g/l is a solution of plasma protein and belongs to the pharmacotherapeutic group of plasma substitutes and plasma protein fractions. Plasma is the liquid part of the blood in which blood cells are suspended.
It is used to supplement and maintain blood volume in cases where blood volume is too low.

2. Important information before using Flexbumin 200 g/l

When not to use Flexbumin 200 g/l:

• If the patient is allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Flexbumin 200 g/l, discuss it with your doctor, pharmacist, or nurse.

• If during treatment you experience headache, difficulty breathing, or a feeling of weakness, you should immediately inform your doctor or nurse. This may be an allergic reaction.
• If the patient has any of the following diseases:
• uncompensated heart failure
• hypertension
• esophageal varices (enlarged veins in the esophagus)
• pulmonary edema (fluid in the lungs)
• tendency to spontaneous bleeding
• severe anemia (lack of red blood cells)
• reduced urine production, inform your doctor so that they can take appropriate precautions.

In the case of receiving medicinal products from human blood or plasma, certain measures are taken to prevent the transmission of infections. These include careful selection of donors to exclude individuals who may be at risk of transmitting infections, and testing of individual donations and plasma pools for signs of virus/infection. Manufacturers of such products also include virus inactivation or removal steps in the blood and plasma processing process. Despite this, it cannot be completely ruled out that infectious agents may be transmitted when administering medicinal products obtained from human blood or plasma. This also applies to unknown and newly discovered viruses and other pathogens.
There have been no reports of virus transmission with albumin preparations produced using an approved process, in accordance with the specifications given in the European Pharmacopoeia.
It is recommended that each time Flexbumin 200 g/l is administered, the name and batch number of the preparation should be recorded in order to maintain information on the batches of the medicine used.

Flexbumin 200 g/l and other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide whether you can use Flexbumin 200 g/l during pregnancy or breastfeeding.
The effect of Flexbumin 200 g/l on fertility has not been studied.

Children and adolescents

In clinical trials sponsored by the company, the safety and efficacy of human albumin solution in children and adolescents have not been established. Due to the limited data available on the use of Flexbumin 200 g/l in children, this medicine should only be used when the benefits clearly outweigh the potential risks.

Driving and using machines

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

Flexbumin 200 g/l contains sodium

50 ml bag:
The medicine contains 149.5-184 mg of sodium (the main component of common salt) in each bag. This corresponds to 7.5-9.2% of the maximum recommended daily intake of sodium in the diet for adults.
100 ml bag:
The medicine contains 299-368 mg of sodium (the main component of common salt) in each bag. This corresponds to 15-18.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Flexbumin 200 g/l

Flexbumin 200 g/l is a medicine intended for use in a hospital setting. Therefore, it will be administered in a hospital by the appropriate medical staff. The treating doctor will determine the dose, frequency of administration, and duration of treatment, depending on the individual patient's condition.

Using a higher dose of Flexbumin 200 g/l than recommended

Flexbumin 200 g/l is administered only under the strict supervision of a doctor. Therefore, overdose is very unlikely. However, in the case of too high a dose or infusion rate, excessive increase in blood volume (hypervolemia) may occur. This can lead to overloading of the heart and circulatory system (circulatory overload). The first symptoms of such an overdose include:

• headache,
• difficulty breathing (dyspnea),
• enlargement of neck veins (neck vein distension). If such symptoms occur, you should immediately inform your doctor, pharmacist, or nurse.

Your doctor, pharmacist, or nurse may also notice symptoms such as:

• increased blood pressure (hypertension),
• increased central venous pressure,
• presence of fluid in the lungs (pulmonary edema). In all such cases, the doctor, pharmacist, or nurse must immediately stop the infusion, and the patient's hemodynamic parameters must be closely monitored.

Using Flexbumin 200 g/l in children and adolescents

The doctor will decide whether children and adolescents can receive Flexbumin 200 g/l.

4. Possible side effects

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

• Rarely occurring side effects usually disappear quickly after reducing the infusion rate or stopping the infusion.
• In the event of shock (severe allergic reaction), the infusion should be stopped immediately and appropriate treatment started.
• If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Other side effects observed after the introduction of human albumin to the market include:
hypersensitivity/allergic reactions, headache, rapid heartbeat, low blood pressure, apnea or discomfort during breathing, vomiting, altered taste, urticaria, itching, chills, myocardial infarction, irregular heartbeat, fluid accumulation in the lung.

Additional side effects in children and adolescents

Data on the safety of use in children and adolescents are limited. No additional side effects are known in children and adolescents.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Flexbumin 200 g/l

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not freeze.
Store the bag in the outer carton to protect from light.
The contents should be used immediately after opening the package.
Do not use this medicine if the solution is cloudy or contains sediment.

6. Contents of the pack and other information

What Flexbumin 200 g/l contains

• The active substance is human albumin. 1 liter of solution contains 200 g of total protein, of which at least 95% is human albumin.
• The other ingredients are: sodium chloride, sodium caprylate, sodium acetyltryptophanate, and water for injections. Total sodium ion content: 130 - 160 mmol/l

What Flexbumin 200 g/l looks like and contents of the pack

Flexbumin 200 g/l is a solution for infusion in a bag.
Pack sizes:
24 x 50 ml (2 cartons of 12 pieces or a carton containing 24 pieces)
12 x 100 ml (2 cartons of 6 pieces or a carton containing 12 pieces)
1 x 50 ml (1 piece)
1 x 100 ml (1 piece)
The solution is clear and slightly viscous, almost colorless, yellow, amber, or green.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw

Manufacturer:

Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna, Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria

Flexbumin 200 g/l - Infusionslösung

Croatia

Flexbumin 200 g/l solution for infusion

Cyprus

Flexbumin 200 G/L

Czech Republic

Flexbumin

Denmark

Flexbumin

Estonia

Flexbumin 200 g/l

Greece

FLEXBUMIN Διάλυμα για έγχυση 200 G/L

Hungary

Flexbumin 200 g/l oldatos infúzió

Iceland

Flexbumin 200 g/l, innrennslislyf, lausn

Ireland

Flexbumin 200 g/l

Italy

FLEXBUMIN

Latvia

Flexbumin 200 g/l šķīdums infūzijām

Liechtenstein

Flexbumin 200 g/l

Lithuania

Flexbumin 200 g/l infuzinis tirpalas

Malta

Flexbumin 200 g/l

Netherlands

Flexbumin 200 g/l, oplossing voor infusie

Norway

Flexbumin 200 g/l

Poland

Flexbumin 200 g/l

Portugal

FLEXBUMIN

Slovakia

Flexbumin 200 g/l

Slovenia

Flexbumin 200 g/l raztopina za infundiranje

Spain

Flexbumin 200 g/l solución para perfusión

United Kingdom

Flexbumin 200 g/l
Date of last revision of the leaflet:12/2021

Information intended for healthcare professionals only:

Before and during administration of Flexbumin 200 g/l

• Albumin solutions should not be diluted with water for injections, as this may cause hemolysis in patients receiving the medicine.
• In the case of administration of large volumes, the product should be warmed to room temperature or body temperature before use.
• For safety reasons, the name and batch number of Flexbumin 200 g/l administered to the patient should be recorded.
• If the dose and infusion rate are not adjusted to the patient's circulatory status, overhydration may occur. If the first clinical signs of circulatory overload (headache, dyspnea, neck vein distension) or increased blood pressure, increased venous pressure, or pulmonary edema occur, the infusion should be stopped immediately.

układu krążenia (ból głowy, duszność, przepełnienie żył szyjnych) lub wzrostu ciśnienia krwi,
zwiększenia ciśnienia żylnego lub obrzęku płuc, należy natychmiast przerwać infuzję.

Preparation for administration

Flexbumin 200 g/l can be administered directly intravenously or after dilution in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride).

Administration of Flexbumin 200 g/l

• Do not use the bag if the tip protector is damaged, removed, or missing.
• Use only if the bag's welds are intact. Discard if a leak is detected.
• Do not use cloudy or sediment-containing solutions. This may indicate that the protein is unstable or that the solution has been contaminated. Infusion is performed intravenously using a single-use, sterile, and apyrogenic infusion set. Before introducing the infusion set into the bag port, the port should be disinfected using an appropriate antiseptic agent. After connecting the infusion set to the bag, the administration of the solution should be started immediately.
• The infusion rate should be adjusted to the individual situation and indications. During plasma exchange, the infusion rate should be adjusted to the rate of removal.

Shelf life

The contents should be used immediately after opening the package. Any unused product or waste material should be disposed of in accordance with local requirements.

Incompatibilities

This medicinal product should not be mixed with other medicines (except for isotonic solutions, such as 5% glucose or 0.9% sodium chloride), whole blood, and red blood cell concentrates. Human albumin should also not be mixed with protein hydrolysates (e.g., parenteral nutrition) or solutions containing alcohol, as such combinations may cause protein precipitation.