Human Albumin 200 g/l Takeda

Leaflet attached to the packaging: information for the user

Human Albumin 200 g/l Takeda

Infusion solution
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.
• In case of any doubts, consult a doctor, pharmacist, or nurse. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Human Albumin 200 g/l Takeda and what is it used for

Human Albumin 200 g/l Takeda contains a protein called albumin, found in the liquid part of the blood (plasma) and belongs to a group of medicines called "plasma substitutes and plasma protein fractions". It is produced from human blood collected from blood donors.
A 50 ml vial contains 10 g of human albumin
A 100 ml vial contains 20 g of human albumin
Human albumin is used to supplement and maintain blood volume in patients who have lost blood or fluid in specific medical situations.
The choice of albumin instead of an artificial colloid solution and the required dose will depend on the patient's clinical situation.

2. Important information before using Human Albumin 200 g/l Takeda

When not to use Human Albumin 200 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 200 g/l Takeda, the patient should discuss it with their doctor, pharmacist, or nurse.

• if it is suspected that an allergic reaction has occurred during treatment, with difficulty breathing, feeling of fainting, or other symptoms. In such a case, the doctor or nurse should be informed immediately, as it may be necessary to interrupt the infusion and possibly apply standard shock treatment.
• if the patient has any of the following diseases:
• uncompensated heart failure;
• hypertension;
• esophageal varices (enlargement of esophageal veins);
• pulmonary edema (fluid in the lungs);
• tendency to spontaneous bleeding;
• severe anemia (lack of red blood cells);
• lack of urine production. If any of these cases apply to the patient, they should inform their 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 blood and plasma donors to exclude individuals who may be transmitting an infection, and testing of individual donations and plasma pools to detect viruses (infections). Manufacturers of such products also include virus inactivation or removal steps in the blood and plasma processing process. Despite this, it is not possible to completely exclude the possibility of transmitting infectious agents. This also applies to unknown and newly discovered viruses and other types of infections.
There have been no reports of transmitting viral infections through albumins produced in manufacturing processes compliant with the specifications listed in the European Pharmacopoeia.
It is strongly recommended that each time Human Albumin 200 g/l Takeda is administered to a patient, the name and batch number of the product should be recorded to maintain information about the product batches used.

Human Albumin 200 g/l Takeda and other medicines

• The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
• Currently, there are no known interactions with taking human albumin with other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor. The doctor will decide whether Human Albumin 200 g/l Takeda can be used during pregnancy or breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Human Albumin 200 g/l Takeda contains sodium

50 ml vial:
This medicine contains 115 – 149.5 mg of sodium (the main component of common salt) per vial. This corresponds to 5.8 – 7.5% of the maximum recommended daily intake of sodium in the diet for adults by the WHO.
100 ml vial:
This medicine contains 230 – 299 mg of sodium (the main component of common salt) per vial. This corresponds to 11.5

• 15% of the maximum recommended daily intake of sodium in the diet for adults by the WHO.

3. How to use Human Albumin 200 g/l Takeda

Human Albumin 200 g/l Takeda is a medicine intended for use in a hospital setting. Therefore, it will be administered in a hospital by qualified medical personnel. The doctor will determine the dose to be administered, the frequency of administration, and the duration of treatment, depending on the individual patient's condition. During the administration of Human Albumin, the doctor will continuously monitor the patient's condition, measuring blood pressure and pulse, and performing blood tests to ensure that the patient is not receiving too high a dose. If headache, difficulty breathing, or increased blood pressure occur, the doctor should be informed.

Using more than the recommended dose of Human Albumin 200 g/l Takeda

In case of suspected overdose of Human Albumin 200 g/l Takeda, the doctor or pharmacist should be informed immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, the infusion should be stopped immediately and appropriate treatment should be applied:

• anaphylactic shock (very rare: may affect less than 1 in 10,000 patients)
• hypersensitivity/allergic reactions (unknown: cannot be estimated from the available data)

The following side effects have also been reported:
Rare: may affect up to 1 in 1000 patients

• nausea (feeling sick)
• sudden flushing
• skin rash
• fever Unknown: frequency cannot be estimated from the available data
• headache
• altered taste
• heart attack
• irregular heartbeat
• rapid heartbeat
• abnormally low blood pressure
• fluid accumulation in the lungs
• breathlessness or discomfort while breathing
• vomiting
• hives
• itching
• chills

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
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 Human Albumin 200 g/l Takeda

The medicine should be stored out of 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 month stated.
Do not store above 25°C.
Do not freeze.
Store glass vials in a cardboard box to protect from light.
The contents must be used immediately after opening the packaging.
Do not use this medicine if the solution is cloudy or contains insoluble particles.

6. Contents of the packaging and other information

What Human Albumin 200 g/l Takeda contains

• The active substance is: human albumin Each 100 ml contains 20 g of total protein, of which at least 95% is human albumin.
• The other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections.

Total sodium ion content: 100 –130 mmol/l

What Human Albumin 200 g/l Takeda looks like and what the packaging contains

Human Albumin 200 g/l Takeda is a clear, slightly viscous liquid; it is almost colorless, yellow, amber, or green. It is a sterile solution for intravenous infusion in glass vials of 50 ml or 100 ml.

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 and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:01/2022
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Information intended for healthcare professionals only:

• Human Albumin 200 g/l Takeda solution should be administered intravenously, directly administering the contents of the packaging as an infusion.
• The albumin solution should not be diluted with water for injections, as this may cause hemolysis in patients receiving the medicine.
• Do not use if the seal is broken. If a leak is found, the product should be discarded.
• The solution should be clear, slightly viscous, almost colorless, yellow, amber, or green. Do not use cloudy or sediment-containing solutions. This may indicate that the protein is unstable or that the solution has been contaminated. The contents should be used immediately after opening the packaging.
• Infusion should be performed intravenously using a single-use, sterile, and apyrogenic infusion set. Before connecting the infusion set to the vial stopper, the stopper should be disinfected using an appropriate antiseptic agent. After connecting the infusion set to the vial, the infusion should be started immediately. Any unused product should be disposed of in accordance with local regulations.
• The rate of administration should be adjusted according to the individual situation and indications.
• During plasma exchange, the infusion rate should be adjusted to the rate of removal.
• In the case of administering large volumes, the product should be warmed to room temperature or body temperature before use.
• When administering albumin concentrates, it is necessary to ensure proper hydration of the patient. The patient's condition should be monitored to prevent circulatory overload and fluid overload.
• During albumin administration, the patient's electrolyte levels should be monitored, and appropriate actions should be taken to restore or maintain electrolyte balance.
• It is necessary to ensure adequate substitution of other blood components (coagulation factors, electrolytes, platelets, and red blood cells).
• For safety reasons, the batch number of the administered Human Albumin 200 g/l Takeda should be recorded.
• Human albumin should not be mixed with other medicines, 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 these combinations may cause protein precipitation.
• If the dose and infusion rate are too high, fluid overload may occur. In the event of the first clinical symptoms of circulatory overload (headache, shortness of breath, jugular venous distension) or increased blood pressure, the infusion should be stopped immediately, and the patient's hemodynamic parameters should be closely monitored.