Human albumin 50 g/l takeda

Package leaflet: Information for the user

Human Albumin 50 g/l Takeda
concentrate for solution for infusion
human albumin
Please read all of this leaflet carefully before this medicine is given to you, because it contains
important information for you.

• 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 a specific patient only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Human Albumin 50 g/l Takeda is and what it is used for
2. What you need to know before you are given Human Albumin 50 g/l Takeda
3. How Human Albumin 50 g/l Takeda is given
4. Possible side effects
5. How to store Human Albumin 50 g/l Takeda
6. Contents of the pack and other information

1. What Human Albumin 50 g/l Takeda is and what it is used for

Human Albumin 50 g/l Takeda contains a protein called albumin, which is normally present in the liquid part of the blood (plasma), and belongs to a group of medicines known as "plasma substitutes and plasma protein fractions". It is manufactured from human blood collected from blood donors.
The 250 ml vial contains 12.5 g of human albumin.
The 500 ml vial contains 25 g of human albumin.
Human albumin is used to restore and maintain circulating blood volume in patients who have lost blood or fluid due to certain medical conditions.
The decision to use albumin instead of an artificial colloidal fluid and the required dose will depend on the individual patient's clinical condition.

2. Important information before using Human Albumin 50 g/l Takeda

When not to use Human Albumin 50 g/l Takeda

• 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 Human Albumin 50 g/l Takeda, discuss this with your doctor, pharmacist or nurse.
• if an allergic reaction is suspected during treatment, with symptoms such as difficulty breathing, feeling faint or other symptoms. In such a case, inform your doctor or nurse immediately, as the infusion must be stopped promptly and standard treatment for shock may need to be initiated.
• if the patient has any of the following conditions:
  • decompensated 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);
• absence of urine production. If any of these conditions apply to the patient, the doctor should be informed so that appropriate precautions can be taken.

When medicinal products derived from human blood or plasma are used, certain measures are taken to prevent the transmission of infectious agents. These include careful selection of blood and plasma donors to exclude individuals who may transmit infection, as well as testing of individual donations and pooled plasma for the presence of viruses (infections). In addition, manufacturers of such products include steps in the manufacturing process designed to inactivate or remove viruses. Nevertheless, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to unknown or newly emerging viruses and other types of infections.
There have been no reports of transmission of viral infections through albumin products manufactured according to processes compliant with the specifications of the European Pharmacopoeia.
It is strongly recommended that each time Human Albumin 50 g/l Takeda is administered to a patient, the product name and batch number should be recorded to maintain traceability of the batches used.

Human Albumin 50 g/l Takeda and other medicines

• Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
• Currently, no complications associated with the concomitant use of human albumin and other medicines are known.

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 her doctor. The doctor will decide whether Human Albumin 50 g/l Takeda can be used during pregnancy or breastfeeding.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Human Albumin 50 g/l Takeda contains sodium
250 ml vial:
This medicine contains 747.5 – 920 mg of sodium (the main component of table salt) per vial. This corresponds to 37.38 – 46% of the maximum daily sodium intake of 2 g recommended by WHO in the adult diet.
500 ml vial:
This medicine contains 1495 – 1840 mg of sodium (the main component of table salt) per vial. This corresponds to 74.75 – 92% of the maximum daily sodium intake of 2 g recommended by WHO in the adult diet.

3. How to use Human Albumin 50 g/l Takeda

Human Albumin 50 g/l Takeda is a medicine intended for use in a closed medical setting.
Therefore, it will be administered in a hospital by qualified medical personnel. The treating physician will determine
the dose to be administered, the frequency of administration, and the duration of treatment, depending on the individual
condition of the patient. During administration of Human Albumin, the physician will continuously monitor the patient's condition,
measuring blood pressure and pulse, and performing blood tests to ensure that the patient does not receive an excessive dose.
If headache, difficulty breathing, or increased blood pressure occurs, inform the physician immediately.
Administration of a higher than recommended dose of Human Albumin 50 g/l Takeda
If an overdose of Human Albumin 50 g/l Takeda is suspected, inform the physician or pharmacist immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur, the infusion must be stopped immediately and appropriate treatment initiated:

• Anaphylactic shock (very rare: may affect fewer than 1 in 10,000 patients)
• Hypersensitivity/allergic reactions (unknown frequency: based on available data, frequency cannot be estimated)

The following adverse reactions have also been reported:
Rare: may affect fewer than 1 in 1,000 patients

• Nausea (feeling of sickness)
• Sudden flushing
• Skin rash
• Fever

Unknown frequency: frequency cannot be estimated based on available data

• Headache
• Altered sense of taste
• Myocardial infarction
• Irregular heartbeat
• Rapid heartbeat
• Abnormal low blood pressure
• Fluid accumulation in the lungs
• Apnoea or breathing discomfort
• Vomiting
• Urticaria
• Itching
• Chills

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 this medicine.

5. How to store Human Albumin 50 g/l Takeda

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not freeze.
Store glass vials in the cardboard packaging to protect from light.
The contents must be used immediately after opening the container.
Do not use this medicine if the solution appears cloudy or contains insoluble particles.

6. Contents of the pack and other information

What Human Albumin 50 g/l Takeda contains

• The active substance is: human albumin. Each 100 ml contains 5 g of total protein, of which at least 95% is human albumin.
• Other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections. Total sodium ion content: 130–160 mmol/l.

What Human Albumin 50 g/l Takeda looks like and contents of the pack
Human Albumin 50 g/l Takeda is a clear, slightly viscous liquid; it is almost colourless, yellow, amber, or green. It is a sterile solution for intravenous infusion supplied in 250 ml or 500 ml glass vials.

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 European Economic Area and in Great Britain (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:

• Human Albumin 50 g/l Takeda solution must be administered intravenously by directly infusing the contents of the container.
• Albumin solutions must not be diluted with water for injections, as this may cause hemolysis in patients receiving the medication.
• Do not use if the closure is damaged. If leakage is observed, the product should be discarded.
• The solution should be clear, slightly viscous, almost colorless, yellow, amber, or green. Do not use solutions that are cloudy or contain a precipitate. This may indicate protein instability or contamination of the solution. The contents should be used immediately after opening the container.
• Infusion should be administered intravenously using a single-use, sterile, and pyrogen-free infusion set. Before connecting the infusion set to the vial stopper, disinfect the stopper with an appropriate antiseptic agent. After connecting the infusion set to the vial, begin infusion without delay. Any unused product residue should be discarded in accordance with local regulations.
• 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.
• When large volumes are administered, the product should be warmed to room temperature or body temperature before use.
• When administering albumin concentrates, ensure adequate hydration of the patient. Monitor the patient closely to prevent circulatory overload and fluid overload.
• During albumin administration, monitor the patient's electrolyte levels and take appropriate measures to restore or maintain electrolyte balance.
• Ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets, and erythrocytes).
• For safety reasons, record the batch number of the administered Human Albumin 50 g/l Takeda.
• Human albumin must not be mixed with other medications, whole blood, or red blood cell concentrates. Human albumin should also not be mixed with protein hydrolysates (e.g., parenteral nutrition) or alcohol-containing solutions, as such combinations may cause protein precipitation.
• If the dose or infusion rate is too high, fluid overload may occur. In case of early clinical signs of circulatory overload (headache, dyspnea, jugular vein distension) or increased blood pressure, elevated central venous pressure, or pulmonary edema, the infusion must be stopped immediately and the patient's hemodynamic parameters closely monitored.