Albumin Baxalta

Package leaflet: Information for the user

ALBUMINA BAXALTA 50 g/l

Infusion solution
Human albumin
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Albumina Baxalta is and what it is used for
2. What you need to know before using Albumina Baxalta
3. How to use Albumina Baxalta
4. Possible side effects
5. How to store Albumina Baxalta
6. Contents of the pack and other information

1. What Albumina Baxalta is and what it is used for

Albumina Baxalta contains a protein called albumin, which is present in the liquid component of blood (plasma), and belongs to the group of medicines known as "plasma substitutes and plasma protein fractions". It is prepared from human blood collected from 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 restore and maintain blood volume in patients who have lost blood or fluids due to certain medical conditions.
The choice of albumin rather than an artificial substitute, as well as the required dose, depends on the individual patient's clinical condition.

2. What you need to know before using Albumina Baxalta

Do not use Albumina Baxalta

• if you are allergic to human albumin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Albumina Baxalta

• if you think you are having an allergic reaction during treatment, with difficulty breathing, feeling faint or other symptoms. If this happens, inform your doctor or nurse immediately, as the infusion must be stopped and medical treatment for shock may be required.
• if you have:
• uncontrolled heart failure
• hypertension
• esophageal varices (swollen veins in the esophagus)
• pulmonary edema (fluid in the lungs)
• a tendency to spontaneous bleeding
• severe anemia (lack of red blood cells)
• absence of urine production
  If you think any of these conditions apply to you, consult your doctor, who will take appropriate precautions.

When medicines are produced from human blood or plasma, certain safety measures are applied to prevent transmission of infections to patients. These include careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded, and testing of each donation and plasma pool for viruses and infections. In addition, manufacturers of these medicines apply processing procedures that can inactivate or remove viruses. Nevertheless, whenever medicines prepared from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely excluded. This also applies to unknown or emerging viruses or other types of infections.
No cases of viral infection have been reported with albumin produced according to the specifications of the European Pharmacopoeia using well-established processes.
It is strongly recommended to record the name and batch number of each dose of Albumina Baxalta administered to you. This allows traceability of the batches used.

Other medicines and Albumina Baxalta

• Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
• No specific complications related to the concomitant use of human albumin with other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor. Your doctor will decide whether you can take Albumina Baxalta during pregnancy or breastfeeding.

Driving and use of machines
No effects on the ability to drive vehicles or operate machinery have been observed.

Albumina Baxalta 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 recommended maximum daily intake of 2 g of sodium for an adult.
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 recommended maximum daily intake of 2 g of sodium for an adult.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Albumina Baxalta

Albumina Baxalta is a medicinal product intended for hospital use. Therefore, it is administered in a hospital setting by qualified healthcare personnel. Your doctor will determine the amount of product to administer, the frequency of administrations, and the duration of treatment based on your specific condition. While you are receiving human albumin, your doctor will monitor your condition by measuring your blood pressure and heart rate, as well as through blood tests, to ensure that the amount you are receiving is not too high. If you experience headache, difficulty breathing, or an increase in blood pressure, contact your doctor immediately.
If you have received more Albumina Baxalta than you should
If you have received more Albumina Baxalta than prescribed, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the side effects listed below occur, the infusion must be stopped immediately and appropriate treatment started:

• anaphylactic shock (very rare: may affect up to 1 in 10,000 people)
• hypersensitivity/allergic reactions (not known: frequency cannot be determined from the available data)

The following side effects have also been reported:

Rare: may affect up to 1 in 1,000 people

• nausea (feeling unwell)
• facial flushing
• skin rash
• fever

Not known: frequency cannot be determined from the available data

• headache
• taste disturbance
• heart attack
• irregular heartbeat
• rapid heartbeat
• abnormally low blood pressure
• fluid accumulation in the lungs
• shortness of breath or breathing discomfort
• vomiting
• hives
• itching
• chills

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Albumina Baxalta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Store the glass vial in the outer packaging to protect the medicine from light.
After opening the packaging, the contents should be used immediately.
Do not use Albumina Baxalta if you notice that the solution is cloudy or if particles are present.

6. Package contents and other information

What Albumina Baxalta contains

• The active substance is: human albumin. 100 ml contain 5 g of total protein, of which at least 95% is human albumin.
• The other components are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections.

Total sodium ion content: 130 – 160 mmol/l
Description of the appearance of Albumina Baxalta and contents of the pack
It is a clear, slightly viscous liquid; almost colourless or yellow, amber, or green in colour. It is a
sterile solution for intravenous infusion, contained in 250 ml or 500 ml glass vials.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna
Manufacturer
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

The following information is intended exclusively for healthcare professionals:

• Human albumin solution 50 g/l must be administered intravenously by direct infusion of the contents of the container.
• Human albumin solution 50 g/l must not be diluted with water for injections, as this may cause haemolysis in recipients.
• Do not use if the seal is not intact. If leakage is observed, discard the product.
• Solutions should appear clear, slightly viscous, and almost colourless to yellow, amber, or green. Turbid solutions or those containing precipitates must not be used, as this may indicate protein instability or contamination. After opening the container, the contents must be used immediately.
• Infusion must be performed intravenously using a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set into the closure cap, the cap must be disinfected with an appropriate antiseptic agent. After connecting the infusion set to the vial, the contents must be infused immediately. Unused solutions must be properly discarded.
• The infusion rate must be adjusted according to individual circumstances and the indication.
• In the case of plasmapheresis, the infusion rate must be adjusted according to the rate of blood removal.
• When administering large volumes, the product must be brought to room temperature before use.
• When administering concentrated albumin, adequate patient hydration must be ensured. Patients must be adequately monitored to prevent circulatory overload and excessive fluid retention.
• When albumin is administered, the patient's electrolyte balance must be monitored, and appropriate measures must be taken, if necessary, to restore or maintain it.
• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes) must be ensured.
• For safety reasons, the batch number of the administered Albumina Baxalta must be recorded.
• Human albumin must not be mixed with other medicinal products, whole blood, or packed red blood cells. Furthermore, human albumin must not be mixed with hydrolysed proteins (e.g., parenteral nutrition) or alcohol-containing solutions, as these combinations may cause protein precipitation.
• Excessive dose and infusion rate may lead to hypervolaemia. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein distension), increased blood pressure, elevated central venous pressure, or pulmonary oedema, the infusion must be stopped immediately and the patient's haemodynamic parameters must be closely monitored.

Package leaflet: Information for the user

ALBUMINA BAXALTA 200 g/l

Infusion solution
Human albumin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Albumina Baxalta is and what it is used for
2. What you need to know before using Albumina Baxalta
3. How to use Albumina Baxalta
4. Possible side effects
5. How to store Albumina Baxalta
6. Contents of the pack and other information

1. What Albumina Baxalta is and what it is used for

Albumina Baxalta contains a protein called albumin, which is present in the liquid component of blood (plasma), and belongs to a group of medicines known as "plasma substitutes and plasma protein fractions". It is prepared 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 restore and maintain blood volume in patients who have lost blood or fluids due to certain medical conditions.
The choice of albumin rather than an artificial substitute, as well as the required dose, will depend on the individual patient's clinical condition.

2. What you need to know before using Albumina Baxalta

Do not use Albumina Baxalta

• if you are allergic to human albumin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Albumina Baxalta

• if you suspect you are having an allergic reaction during treatment, with symptoms such as difficulty breathing, feeling faint, or other symptoms. If this occurs, inform your doctor or nurse immediately, as the infusion must be stopped and medical treatment for shock may be required.
• if you have:
• uncontrolled heart failure
• hypertension
• esophageal varices (enlarged veins in the esophagus)
• pulmonary edema (fluid in the lungs)
• a tendency toward spontaneous bleeding
• severe anemia (lack of red blood cells)
• absence of urine production
  If you think any of these conditions apply to you, consult your doctor, who will take appropriate precautions.

When medicines are manufactured from human blood or plasma, certain safety measures are applied to prevent transmission of infections to patients. These include careful selection of blood and plasma donors to ensure that individuals at risk of carrying infections are excluded, and testing of each donation and plasma pool for viruses and infections. In addition, manufacturers apply processing procedures that can inactivate or remove viruses during the production of these medicines. Nevertheless, whenever medicines prepared from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely ruled out. This also applies to unknown or emerging viruses or other types of infections.
No cases of viral infection have been reported with albumin produced according to the specifications of the European Pharmacopoeia using well-established processes.
It is strongly recommended to record the name and batch number of each dose of Albumina Baxalta administered to you. This allows traceability of the batches used.

Other medicines and Albumina Baxalta

• Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
• No specific complications related to the concomitant use of human albumin with other medicines are known.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor. Your doctor will decide whether you can take Albumina Baxalta during pregnancy or while breastfeeding.

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

Albumina Baxalta contains sodium.
50 ml vial:
This medicine contains 115–149.5 mg of sodium (the main component of table salt) per vial.
This corresponds to 5.8–7.5% of the recommended maximum daily intake of 2 g of sodium for an adult.
100 ml vial:
This medicine contains 230–299 mg of sodium (the main component of table salt) per vial.
This corresponds to 11.5–15% of the recommended maximum daily intake of 2 g of sodium for an adult.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Albumina Baxalta

Albumina Baxalta is a medicinal product intended for hospital use. Therefore, it is administered in a hospital setting by qualified healthcare personnel. Your doctor will determine the amount of product to administer, the frequency of administration, and the duration of treatment based on your specific condition. Your doctor will monitor your condition by measuring your blood pressure and heart rate and through blood tests while you are receiving human albumin, to ensure that the amount you are receiving is not too high. If you experience headache, difficulty breathing, or an increase in blood pressure, inform your doctor immediately.
If you take more Albumina Baxalta than you should
If you have taken more Albumina Baxalta than prescribed, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the side effects listed below occur, the infusion must be stopped immediately and appropriate treatment must be started:

• anaphylactic shock (very rare: may affect up to 1 in 10,000 people)
• hypersensitivity/allergic reactions (not known: frequency cannot be determined from available data)

The following additional side effects have also been reported:

Rare: may affect up to 1 in 1,000 people

• nausea (feeling of sickness)
• facial flushing
• skin rash
• fever

Not known: frequency cannot be determined from available data

• headache
• taste disturbance
• heart attack
• irregular heartbeat
• rapid heartbeat
• abnormally low blood pressure
• fluid accumulation in the lungs
• shortness of breath or breathing discomfort
• vomiting
• hives
• itching
• chills

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly through the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Albumina Baxalta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the glass vial in the outer packaging to protect the medicine from light.
After opening the packaging, the contents should be used immediately.
Do not use Albumina Baxalta if you notice the solution is cloudy or if particles are present.

6. Pack contents and other information

What Albumina Baxalta contains

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

Total sodium ion content: 100–130 mmol/l
Description of the appearance of Albumina Baxalta and pack contents
It is a clear, slightly viscous liquid; almost colourless, yellow, amber or green in colour. It is a sterile solution for intravenous infusion contained in 50 ml or 100 ml glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna
Manufacturer
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

The following information is intended exclusively for healthcare professionals:

• Human albumin 200 g/l solution must be administered intravenously, either by direct infusion of the container contents or after dilution in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride).
• Human albumin 200 g/l solution must not be diluted with water for injections, as this may cause hemolysis in recipients.
• Do not use if the seal is not intact. If leakage is detected, discard the product.
• Solutions should appear clear, slightly viscous, nearly colorless, or yellow, amber, or green. Cloudy solutions or those containing sediments must not be used, as this may indicate protein instability or contamination. After opening the container, its contents must be used immediately.
• Infusion must be performed intravenously using a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set into the closure cap, the cap must be disinfected with an appropriate antiseptic agent. After connecting the infusion set to the vial, the contents must be infused immediately. Unused solutions must be properly discarded.
• The infusion rate must be adjusted according to individual patient conditions and the indication.
• In plasma exchange procedures, the infusion rate must be adjusted according to the plasma withdrawal rate.
• When large volumes are administered, the product must be brought to room temperature before use.
• When administering concentrated albumin, ensure adequate hydration of the patient. Patients must be adequately monitored to prevent circulatory overload and excessive hydration.
• When albumin is administered, monitor the patient's electrolyte balance and, if necessary, take appropriate measures to restore or maintain it.
• Ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
• For safety reasons, the batch number of the administered Albumina Baxalta must be recorded.
• Human albumin must not be mixed with other medicinal products (except for the recommended diluents such as 5% glucose or 0.9% sodium chloride), whole blood, or packed red blood cells. Furthermore, human albumin must not be mixed with hydrolyzed proteins (e.g., parenteral nutrition) or alcohol-containing solutions, as these combinations may cause protein precipitation.
• Excessive dose or infusion rate may lead to hypervolemia. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein distension), increased blood pressure, elevated central venous pressure, or pulmonary edema, the infusion must be stopped immediately and the patient's hemodynamic parameters must be closely monitored.

Package leaflet: information for the user

ALBUMIN BAXALTA 250 g/l

Infusion solution
Human albumin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Albumin Baxalta is and what it is used for
2. What you need to know before using Albumin Baxalta
3. How to use Albumin Baxalta
4. Possible side effects
5. How to store Albumin Baxalta
6. Contents of the pack and other information

1. What Albumina Baxalta is and what it is used for

Albumina Baxalta contains a protein called albumin, which is present in the liquid component of blood (plasma), and belongs to a group of medicines known as "plasma substitutes and plasma protein fractions". It is prepared from human blood collected from blood donors.
A 50 ml vial contains 12.5 g of human albumin.
A 100 ml vial contains 25 g of human albumin.
Human albumin is used to restore and maintain blood volume in patients who have lost blood or fluids due to certain medical conditions.
The choice of albumin rather than an artificial substitute, and the required dose, will depend on the individual patient's clinical condition.

2. What you need to know before using Albumina Baxalta

Do not use Albumina Baxalta

• if you are allergic to human albumin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Albumina Baxalta

• if you suspect you are having an allergic reaction during treatment, with symptoms such as difficulty breathing, feeling faint or other symptoms. If this occurs, inform your doctor or nurse immediately, as the infusion must be stopped and medical treatment for shock may be required.
• if you have:
• uncontrolled heart failure
• hypertension
• esophageal varices (swollen veins in the esophagus)
• pulmonary edema (fluid in the lungs)
• a tendency towards spontaneous bleeding
• severe anemia (lack of red blood cells)
• absence of urine production If you think any of these conditions apply to you, consult your doctor, who will take appropriate precautions.

When medicines are manufactured from human blood or plasma, certain safety measures are applied to prevent transmission of infections to patients. These include careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded, and testing of each donation and plasma pool for viruses and infections. Furthermore, manufacturers of these medicines apply processing procedures that can inactivate or remove viruses during production. Nevertheless, whenever medicines derived from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely ruled out. This also applies to unknown or emerging viruses or other types of infections.
No cases of viral infection have been reported with albumin produced according to European Pharmacopoeia specifications using well-established processes.
It is strongly recommended to record the name and batch number of each dose of Albumina Baxalta administered to you. This allows traceability of the batches used.

Other medicines and Albumina Baxalta

• Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
• No specific complications related to the use of human albumin with other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor. Your doctor will decide whether you can receive Albumina Baxalta during pregnancy or breastfeeding.

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

Albumina Baxalta contains sodium.
50 ml vial:
This medicine contains 149.5–184 mg of sodium (the main component of table salt) per vial.
This corresponds to 7.5–9.2% of the maximum recommended daily intake of 2 g of sodium for an adult.
100 ml vial:
This medicine contains 299–368 mg of sodium (the main component of table salt) per vial.
This corresponds to 15–18.4% of the maximum recommended daily intake of 2 g of sodium for an adult.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Albumina Baxalta

Albumina Baxalta is a medicinal product for hospital use. Therefore, it is administered in a hospital setting by qualified healthcare personnel. Your doctor will determine the amount of product to administer, the frequency of administration, and the duration of treatment based on your specific condition. Your doctor will monitor your condition by measuring your blood pressure and heart rate, as well as through blood tests, while you are receiving human albumin, to ensure that the amount you receive is not excessive. If you experience headache, breathing difficulties, or an increase in blood pressure, consult your doctor immediately.
If you use more Albumina Baxalta than you should
If you have used more Albumina Baxalta than prescribed, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

• If any of the following side effects occur, the infusion must be stopped immediately and appropriate treatment must be started:
  • anaphylactic shock (very rare: may affect up to 1 in 10,000 people)
  • hypersensitivity/allergic reactions (not known: frequency cannot be determined from the available data)

The following side effects have also been reported:

Rare: may affect up to 1 in 1,000 people

• nausea (feeling unwell)
• facial flushing
• skin rash
• fever

Not known: frequency cannot be determined from the available data

• headache
• taste disturbance
• heart attack
• irregular heartbeat
• rapid heartbeat
• abnormally low blood pressure
• fluid accumulation in the lungs
• breathlessness or breathing discomfort
• vomiting
• urticaria
• itching
• chills

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Albumina Baxalta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the glass vial in the outer packaging to protect the medicine from light.
After opening the package, the contents should be used immediately.
Do not use Albumina Baxalta if you notice that the solution is cloudy or if particles are present.

6. Package contents and other information

What Albumina Baxalta contains

• The active substance is: human albumin. 100 ml contain 25 g of total protein, of which at least 95% is human albumin.
• The other components are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections.

Total sodium ion content: 130 – 160 mmol/l
Description of the appearance of Albumina Baxalta and contents of the pack
It is a transparent, slightly viscous liquid; almost colourless, yellow, amber or green in colour. It is a
sterile solution for intravenous infusion supplied in 50 ml or 100 ml glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna
Manufacturer
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

The following information is intended exclusively for healthcare professionals:

• Human albumin 250 g/l solution must be administered intravenously by direct infusion of the container contents, or it may be diluted in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride).
• Human albumin 250 g/l solution must not be diluted with water for injections, as this may cause haemolysis in recipients.
• Do not use if the seal is not intact. If leakage is observed, discard the product.
• Solutions should appear clear, slightly viscous, and nearly colourless to yellow, amber, or green. Turbid solutions or those containing precipitates must not be used, as this may

indicate protein instability or contamination of the solution. After opening the
container, its contents must be used immediately.

• Infusion must be performed intravenously using a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set into the closure cap, the cap must be disinfected with an appropriate antiseptic agent. After connecting the infusion set to the vial, the contents must be infused immediately. Unused solutions must be properly discarded.
• The infusion rate must be adjusted according to individual circumstances and the indication.
• In case of plasmapheresis, the infusion rate must be adjusted according to the plasma withdrawal rate.
• When large volumes are administered, the product must be brought to room temperature before use.
• When administering concentrated albumin, adequate patient hydration must be ensured. Patients must be adequately monitored to prevent circulatory overload and excessive hydration.
• When albumin is administered, the patient's electrolyte balance must be monitored, and appropriate measures must be taken, if necessary, to restore or maintain it.
• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes) must be ensured.
• For safety reasons, the batch number of the administered Albumina Baxalta must be recorded.
• Human albumin must not be mixed with other medicinal products (except for the recommended diluents such as 5% glucose or 0.9% sodium chloride), with whole blood, or with packed red blood cells. Furthermore, human albumin must not be mixed with hydrolysed proteins (e.g., parenteral nutrition) or alcohol-containing solutions, as these combinations may cause protein precipitation.
• Excessive dose and infusion rate may lead to hypervolaemia. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein distension), or increased blood pressure, elevated central venous pressure, and pulmonary oedema, the infusion must be stopped immediately and the patient's haemodynamic parameters must be closely monitored.