FLEXBUMIN 200 G/L

Package leaflet: Information for the user

Flexbumin 200 g/l, solution for infusion
Human albumin
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

Flexbumin 200 g/l is a plasma protein solution and belongs to the pharmacotherapeutic group of plasma substitutes and plasma protein fractions. Plasma is the fluid in which blood cells are suspended.
It is used to restore and maintain circulating blood volume when 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 this with a doctor, pharmacist, or nurse.

• If, during treatment, the patient experiences headache, difficulty breathing, or a feeling of weakness, medical personnel should be informed immediately. These may be signs of an allergic reaction.
• If the patient has any of the following conditions:
  • Uncompensated heart failure
  • Hypertension
  • Oesophageal varices (dilated veins in the oesophagus)
  • Pulmonary oedema (fluid in the lungs)
  • A tendency towards spontaneous bleeding
  • Severe anaemia (deficiency of red blood cells)
  • Reduced urine production
    the doctor should be informed so that appropriate precautions can be taken.

When medicinal products derived from human blood or plasma are used, specific measures are taken to prevent the transmission of infections. These include careful selection of donors to exclude individuals at risk of carrying infections, as well as testing of individual donations and pooled plasma for signs of viral/infectious agents. In addition, manufacturers of such products include steps in the blood and plasma processing procedures that inactivate or remove viruses. Nevertheless, it cannot be completely ruled out that medicinal products derived from human blood or plasma may transmit infectious agents, including unknown or newly emerging viruses and other pathogens.
There have been no reports of virus transmission associated with albumin preparations manufactured using a process compliant with the specifications of the European Pharmacopoeia.
It is recommended that the name and batch number of the Flexbumin 200 g/l preparation be recorded each time the medicine is administered, to ensure traceability of the batches used.

Flexbumin 200 g/l and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Flexbumin 200 g/l can be used during pregnancy or breastfeeding.
The effect of Flexbumin 200 g/l on fertility has not been studied.

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

Driving and operating machinery
No influence on the ability to drive or operate machinery 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 table salt) per bag. This corresponds to 7.5–9.2% of the maximum recommended daily dietary intake of sodium for adults.
100 ml bag:
The medicine contains 299–368 mg of sodium (the main component of table salt) per bag. This corresponds to 15–18.4% of the maximum recommended daily dietary intake of sodium 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 qualified medical personnel. The treating physician will determine the
dose to be given, the frequency of administration, and the duration of treatment, depending on the individual
patient's condition.
Administration of a higher than recommended dose of Flexbumin 200 g/l
Flexbumin 200 g/l is administered only under strict medical supervision. Therefore,
overdose is very unlikely. However, if too high a dose is administered or the infusion rate is too fast,
excessive increase in blood volume (hypervolemia) may occur. This may lead to cardiac and circulatory overload
(circulatory overload). Initial symptoms of such an overdose may include:

• headache,
• difficulty breathing (dyspnea),
• distended neck veins (jugular vein distension).
  If any of these symptoms occur, inform the doctor, pharmacist, or nurse immediately.

The doctor, pharmacist, or nurse may also observe symptoms such as:

• increased blood pressure (hypertension),
• elevated 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.
  Use in children and adolescents
  The physician will decide whether children and adolescents should receive Flexbumin 200 g/l.

4. Possible side effects

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

• Rare adverse reactions usually resolve quickly after reducing the infusion rate or stopping the infusion.
• In case of shock (severe allergic reaction), the infusion must be stopped immediately and appropriate treatment initiated.
• If any adverse reaction worsens or if any adverse reactions not listed in the leaflet occur, inform your doctor or pharmacist.

Other adverse reactions observed after marketing of human albumin include:
hypersensitivity/allergic reactions, headache, rapid heartbeat, abnormally low
arterial blood pressure, breathlessness or breathing discomfort, vomiting, altered taste
perception, urticaria, itching, chills, myocardial infarction, irregular heartbeat, fluid accumulation in
the lungs.
Additional adverse reactions in children and adolescents
Data on safety in children and adolescents are limited. No additional adverse reactions specific to children and adolescents are known.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Flexbumin 200 g/l

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

6. Contents of the packaging and other information

What Flexbumin 200 g/l contains

• The active substance is human albumin. One litre of solution contains 200 g of total protein, of which at least 95% is human albumin.
• Other components 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 an infusion solution in a bag.
Pack sizes:
24 x 50 ml (2 cartons of 12 units each or 1 carton containing 24 units)
12 x 100 ml (2 cartons of 6 units each or 1 carton containing 12 units)
1 x 50 ml (1 unit)
1 x 100 ml (1 unit)
The solution is clear, slightly viscous and almost colourless, yellow, amber or green.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw, Poland

Manufacturer:
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna, Austria

This medicinal product is authorised for sale in the following countries of the European Economic Area under the following names:
Austria Flexbumin 200 g/l - Infusionslösung
Croatia Flexbumin 200 g/l otopina za infuziju
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

Information intended exclusively for healthcare professionals:

Before and during administration of Flexbumin 200 g/l

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

Preparation for administration
Flexbumin 200 g/l may 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 closure cap is damaged, detached, or missing.
• Use only if the bag seals are intact. Discard if leakage is observed.
• Do not use solutions that are cloudy or contain particulate matter, as this may indicate protein instability or contamination of the solution.
• The infusion should be administered intravenously using a single-use, sterile, and pyrogen-free infusion set. Before inserting the infusion set into the bag port, disinfect the port using an appropriate antiseptic agent. Once the infusion set is connected to the bag, administration of the solution should begin without delay.
• The infusion rate should be adjusted according to the individual patient's condition and indication. During plasma exchange, the infusion rate should be adjusted to match the plasma removal rate.

Shelf life
The contents should be used immediately after opening the packaging. Any unused portions of the medicinal product or waste material should be disposed of in accordance with local regulations.

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