Human Albumin 50 g/l Takeda

Package Leaflet: Information for the User

Human Albumin 50 g/l Takeda

Infusion Solution
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. 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 package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What Human Albumin 50 g/l Takeda is and what it is used for
• 2. Important information before using Human Albumin 50 g/l Takeda
• 3. How to use Human Albumin 50 g/l Takeda
• 4. Possible side effects
• 5. How to store Human Albumin 50 g/l Takeda
• 6. Contents of the package 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 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 made from human blood donated by blood donors.
A 250 ml vial contains 12.5 g of human albumin
A 500 ml vial contains 25 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 50 g/l Takeda

When not to use Human Albumin 50 g/l Takeda

• if you are 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 it with your doctor, pharmacist, or nurse.

• if you suspect that an allergic reaction has occurred during treatment, with difficulty breathing, feeling of fainting, or other symptoms. In this case, you should immediately inform your doctor or nurse, as it may be necessary to discontinue the infusion and possibly apply standard shock treatment.
• if you have any of the following conditions:
• uncontrolled 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 conditions apply to you, you should 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 blood and plasma donors to exclude individuals who may be transmitting an infection, and testing of individual donations and plasma pools for the detection of viruses (infections). Manufacturers of these types of products also include steps to inactivate or remove viruses from the blood and plasma processing process. Despite this, it is not possible to completely exclude the possibility of transmitting infectious agents. This includes unknown and newly discovered viruses and other types of infections.
There have been no reports of transmission of 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 50 g/l Takeda is administered to a patient, the name and batch number of the product be recorded in order to maintain information about the batches of the product used.

Human Albumin 50 g/l Takeda and other medicines

• Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
• Currently, there are no known interactions with the use of human albumin with other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor. Your doctor will decide whether you can use Human Albumin 50 g/l Takeda during pregnancy or breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines 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 common salt) per vial. This corresponds to 37.38 – 46% of the maximum recommended daily intake of sodium in the diet for adults by the WHO.
500 ml vial:
This medicine contains 1495 – 1840 mg of sodium (the main component of common salt) per vial. This corresponds to 74.75 – 92% of the maximum recommended daily intake of sodium in the diet for adults by the WHO.

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

Human Albumin 50 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. Your doctor will determine the dose to be administered, the frequency of administration, and the duration of treatment, depending on your individual condition. During the administration of Human Albumin, your doctor will continuously monitor your condition, measuring blood pressure and pulse, and performing blood tests to ensure that you are not receiving too high a dose. If you experience headache, difficulty breathing, or increased blood pressure, you should inform your doctor.

Using more than the recommended dose of Human Albumin 50 g/l Takeda

In case of suspected overdose of Human Albumin 50 g/l Takeda, you should immediately inform your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should immediately discontinue the infusion and apply appropriate treatment:

• 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 1,000 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
• abnormal low blood pressure
• fluid accumulation in the lungs
• breathlessness or discomfort while breathing
• vomiting
• hives
• itching
• chills

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
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.
By reporting side effects, you can help 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 month.
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 package.
Do not use this medicine if you notice that the solution is cloudy or contains insoluble particles.

6. Contents of the package 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.
• The 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 package

Human Albumin 50 g/l Takeda is a clear, slightly viscous solution; it is almost colorless, yellow, amber, or green. It is a sterile solution for intravenous infusion in glass vials of 250 ml or 500 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 package leaflet:01/2022
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Information intended for healthcare professionals only:

• Human Albumin 50 g/l Takeda solution should be administered intravenously, directly administering the contents of the package as an infusion.
• Do not dilute albumin solutions with water for injections, as this may cause hemolysis in patients receiving the medicine.
• Do not use if the closure is damaged. 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 solutions or those containing sediment. This may indicate that the protein is unstable or that the solution has been contaminated. The contents should be used immediately after opening the package.
• 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 remaining unused product should be disposed of in accordance with local regulations.
• The rate of administration should be adjusted to the individual situation and indications.
• During plasma exchange, the infusion rate should be adjusted to the rate of removal.
• In the case of administration of large volumes, the product should be warmed to room temperature or body temperature before use.
• In the case of administration of albumin concentrates, ensure adequate hydration of the patient. Monitor the patient's condition to prevent circulatory overload and fluid overload.
• During albumin administration, monitor the patient's electrolyte levels and take appropriate action to restore or maintain electrolyte balance.
• Ensure adequate substitution of other blood components (coagulation factors, electrolytes, platelets, and red blood cells).
• For safety reasons, record the batch number of the administered Human Albumin 50 g/l Takeda.
• 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, immediately discontinue the infusion and closely monitor the patient's hemodynamic parameters.