Albunorm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Albunorm 5%

“50 g/l, solution for infusion”
Human albumin
Please read this leaflet carefully before using this medicine as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Albunorm 5% is and what it is used for
2. What you need to know before receiving Albunorm 5%
3. How to receive Albunorm 5%
4. Possible side effects
5. How to store Albunorm 5%
6. Contents of the pack and other information

1. WHAT ALBUNORM 5% IS AND WHAT IT IS USED FOR.

Albunorm 5% belongs to the following pharmacotherapeutic group: blood substitutes and plasma protein fractions.
This product is administered to patients to restore and maintain circulating blood volume when a volume deficit has been demonstrated.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ALBUNORM 5%

Do not take Albunorm 5%:

• if you are allergic to human albumin preparations 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 taking Albunorm 5%.
Take special care with Albunorm 5%:

• if you are particularly at risk in case of an increase in blood volume, for example in case of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, coagulation disorders, severe anemia, or urinary retention.
• if symptoms of increased blood volume (headache, breathing difficulties, jugular vein distension) or increased arterial pressure occur. Infusion must be stopped immediately.
• if symptoms of an allergic reaction occur. Infusion must be stopped immediately.
• when used in patients with severe traumatic brain injury.

Viral safety
When medicinal products are prepared from human blood or plasma, certain measures are implemented to prevent transmission of infectious agents to the patient.
These include:

• careful selection of blood and plasma donors to exclude those at risk of transmitting infections;
• testing of each donation and plasma pools for the presence of viruses or infections;
• implementation of viral removal/inactivation procedures by manufacturers during the processing of blood or plasma.

Despite these measures, when administering medicinal products prepared from human blood or plasma, the risk of transmitting infectious agents cannot be completely ruled out.
This also applies to viruses of currently unknown nature or emerging viruses, as well as to other pathogenic agents.

There have been no reports of viral infections transmitted following administration of albumin prepared by processes compliant with the specifications of the European Pharmacopoeia.

It is strongly recommended that, whenever you are administered Albunorm 5%, the name and batch number of the product are recorded in order to keep track of the batches used.

Other medicines and Albunorm 5%
To date, no interactions between human albumin and other products have been reported.
However, the Albunorm 5% solution must not be mixed in the same infusion solution with other medicines, whole blood, or concentrated erythrocytes.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Human albumin is a normal component of human blood.
No harmful effects are known when this product has been used during pregnancy and breastfeeding. Particular attention must be paid when adjusting blood volume in pregnant women.
Ask your doctor for advice before taking any medicine.

Driving and using machines
There is no evidence that albumin affects the ability to drive or use machinery.

Albunorm 5% contains sodium
This medicine contains 331–368 mg of sodium (the main component of table salt) per 100 ml of albumin solution. This corresponds to up to 18.4% of the maximum daily recommended dietary intake for an adult.

3. HOW TO USE ALBUNORM 5%

Albunorm 5% is ready for use as an intravenous infusion (drip). The dosage and infusion rate (how quickly the albumin is administered into your vein) will depend on your individual condition.
Your doctor will determine the most appropriate treatment for you.

Instructions

• The product should be warmed to room temperature or body temperature before use.
• The solution should be clear and free from deposits.
• Any unused solution must be discarded.
• If you have any doubts about using this medicine, consult your doctor or pharmacist.

If you are given more Albunorm 5% than you should:
If the dosage or infusion rate is too high, you may experience headache, increased blood pressure, and breathing difficulties. The infusion must be stopped immediately, and your doctor will decide whether further treatment is needed.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions following infusion of human albumin are rare and usually disappear when the infusion rate is reduced or the infusion is stopped.
Rare adverse reactions (in 1 to 10 patients out of 10,000):
Flushing, urticaria, fever, and nausea.
Very rare adverse reactions (in fewer than 1 patient out of 10,000):
Shock due to hypersensitivity reaction.
Frequency not known (cannot be estimated based on the available data):
Confusional state; headache; increased or decreased heart rate; increased or decreased blood pressure; sensation of warmth; shortness of breath; nausea; urticaria; swelling around the eyes, nose, mouth; skin rash; increased sweating; fever; chills.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE ALBUNORM 5%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and
on the carton after {Exp.}. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not freeze.
Once the container of the solution has been opened, the contents must be
used immediately.
The solution should be clear or slightly opalescent.
Do not use solutions that are cloudy or contain deposits.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. This will help
to protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Albunorm 5% contains
The active substance is 50 g/l of human albumin derived from human plasma
(vials of 100 ml, 250 ml, 500 ml).
The excipients are: sodium chloride, acetyltryptophan, caprylic acid, water for
injections.

Description of the appearance of Albunorm 5% and contents of the pack:
Albunorm 5% is an infusion solution in a 100 ml vial (pack of 1 vial and pack of 10 vials).
Albunorm 5% is an infusion solution in a 250 ml vial (pack of 1 vial and pack of 10 vials).
Albunorm 5% is an infusion solution in a 500 ml vial (pack of 1 vial).
The solution is clear, yellow, amber or greenish.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Octapharma Italy S.p.A.
Via Cisanello 145
56124 Pisa
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Albunorm: Denmark, Italy
Albunorm 5%: Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Ireland, Iceland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom
Albunorm 50 g/l: Austria, Estonia, Finland, France, Hungary, Latvia, Lithuania, Norway, Romania, Sweden, Slovenia

Responsible manufacturers for batch release

• Octapharma Pharmazeutika, Produktionsges.m.b.H., Oberlaaerstrasse 235, A-1100 Vienna, Austria
• Octapharma S.A.S., 72 rue du Maréchal Foch, F-67380 Lingolsheim, France
• Octapharma AB, Lars Forssells gata 23, SE-112 75 Stockholm, Sweden
• Octapharma Produktionsgesellschaft Deutschland mbH, Wolfgang-Marguerre-Allee 1, D-31832 Springe, Germany

PACKAGE LEAFLET: INFORMATION FOR THE USER

Albunorm 20%

“200 g/l, solution for infusion”
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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 Albunorm 20% is and what it is used for
2. What you need to know before receiving Albunorm 20%
3. How to use Albunorm 20%
4. Possible side effects
5. How to store Albunorm 20%
6. Contents of the pack and other information

1. WHAT ALBUNORM 20% IS AND WHAT IT IS USED FOR.

Albunorm 20% belongs to the pharmacotherapeutic group: blood substitutes and
plasma protein fractions.
This product is administered to patients to restore and maintain circulating blood
volume when a volume deficit has been demonstrated.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ALBUNORM 20%

Do not take Albunorm 20%:

• if you are allergic to human albumin preparations 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 taking Albunorm 20%.
Pay special attention to Albunorm 20%:

• if you are particularly at risk in case of an increase in blood volume, for example in cases of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, coagulation disorders, severe anemia, or urinary retention.
• if symptoms of increased blood volume (headache, breathing difficulties, jugular vein distension) or increased arterial pressure occur. The infusion must be stopped immediately.
• if symptoms of an allergic reaction occur, the infusion must be stopped immediately.
• when used in patients with severe traumatic brain injury.

Viral safety
When medicinal products are prepared from human blood or plasma, certain measures are taken to prevent the transmission of infectious agents to the patient.
These include:

• careful selection of blood and plasma donors to exclude those at risk of transmitting infections;
• testing of each donation and plasma pools for the presence of viruses or infections;
• implementation of viral removal/inactivation procedures, as required by manufacturers during the processing of blood or plasma.

Nevertheless, when administering medicinal products prepared from human blood or plasma, the risk of transmitting infectious agents cannot be completely excluded.
This also applies to viruses of so far unknown or emerging nature and to other pathogens.

There have been no reports of viral infections transmitted following administration of albumin prepared by processes complying with the specifications of the European Pharmacopoeia.

It is strongly recommended that, each time Albunorm 20% is administered to you, the name and batch number of the product are recorded, in order to keep a record of the batches used.

Other medicines and Albunorm 20%
To date, no interactions between human albumin and other products have been reported.
However, the Albunorm 20% solution must not be mixed in the same infusion solution with other medicines, whole blood, or concentrated red blood cells.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Human albumin is a normal component of human blood.
No harmful effects are known when this product has been used during pregnancy and breastfeeding. Particular attention must be paid to blood volume management in pregnant women.
Consult your doctor before taking any medicine.

Driving and using machines
There is no evidence that albumin affects the ability to drive or operate machinery.

Albunorm 20% contains sodium
This medicine contains 331–368 mg of sodium (the main component of table salt) per 100 ml of albumin solution. This corresponds to up to 18.4% of the maximum daily dietary intake recommended for an adult.

3. HOW TO USE ALBUNORM 20%

Albunorm 20% is ready for use as an intravenous infusion (drip). The dosage and infusion rate (how quickly the albumin is administered into your vein) will depend on your individual condition.
Your doctor will determine the most appropriate treatment for you.

Instructions

• The product must be warmed to room temperature or body temperature before use.
• The solution should be clear and free from deposits.
• Any unused solution must be discarded.
• If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you are given more Albunorm 20% than you should:
If the dosage or infusion rate is too high, you may experience headache, increased blood pressure, and breathing difficulties. The infusion must be stopped immediately, and your doctor will decide whether further treatment is needed.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions following infusion of human albumin are rare and usually disappear when the infusion rate is reduced or the infusion is stopped.

Rare adverse reactions (occurring in 1 to 10 patients out of 10,000):
Hot flushes, urticaria, fever, nausea

Very rare adverse reactions (occurring in less than 1 patient out of 10,000):
Shock due to hypersensitivity reaction

Frequency not known (cannot be estimated from the available data):
Confusion; headache; increased or decreased heart rate; increased or decreased blood pressure; sensation of warmth; shortness of breath; nausea; urticaria; swelling around eyes, nose, mouth; skin rash; increased sweating; fever; chills.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE ALBUNORM 20%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton following {Exp.}. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging to protect from light.
Do not freeze.
Once the container of the solution has been opened, the contents must be used immediately.
The solution should be clear or slightly opalescent.
Do not use solutions that are cloudy or contain deposits.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Albunorm 20% contains
The active substance is 200 g/l human albumin derived from human plasma.
(Vials of 50 and 100 ml).
The excipients are: sodium chloride, acetyltryptophan, caprylic acid, water for injectable preparations.

Description of the appearance of Albunorm 20% and packaging contents:
Albunorm 20% is a solution for infusion in 50 ml vials (packs of 1 vial and 10 vials).
Albunorm 20% is a solution for infusion in 100 ml vials (packs of 1 vial and 10 vials).
The solution is clear, yellow, amber or greenish.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Octapharma Italy S.p.A.
Via Cisanello 145
56124 Pisa
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Albunorm: Denmark, Italy
Albunorm 20%: Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Ireland, Iceland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom
Albunorm 200 g/l: Austria, Estonia, Finland, France, Hungary, Latvia, Lithuania, Norway, Romania, Sweden, Slovenia

Responsible manufacturers for batch release

• Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaerstrasse 235, 1100 Vienna, Austria
• Octapharma S.A.S., 72 rue du Maréchal Foch, 67380 Lingolsheim, France
• Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
• Octapharma Produktionsgesellschaft Deutschland mbH, Wolfgang-Marguerre-Allee 1, 31832 Springe, Germany

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Albunorm 25%

“250 g/l, solution for infusion”
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Albunorm 25% is and what it is used for
2. What you need to know before using Albunorm 25%
3. How to use Albunorm 25%
4. Possible side effects
5. How to store Albunorm 25%
6. Package contents and other information

1. WHAT ALBUNORM 25% IS AND WHAT IT IS USED FOR

Albunorm 25% belongs to the following pharmacotherapeutic group: blood substitutes and plasma protein fractions.
This product is administered to patients to restore and maintain circulating blood volume when a volume deficit has been demonstrated.

2. WHAT YOU NEED TO KNOW BEFORE TAKING ALBUNORM 25%

Do not take Albunorm 25%:
if you are allergic to albumin human preparations or to any of the other
components of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Albunorm 25%.
Exercise particular caution with Albunorm 25%:

• if you are particularly at risk in case of an increase in blood volume, for example in case of severe heart disease, arterial hypertension, esophageal varices, pulmonary edema, coagulation disorders, severe anemia, or urinary retention.
• if symptoms of increased blood volume occur (headache, difficulty breathing, jugular vein distension) or increased arterial pressure. Infusion must be stopped immediately.
• if symptoms of an allergic reaction occur. Infusion must be stopped immediately.
• when used in patients with severe traumatic brain injury.

Viral safety
When medicinal products are prepared from human blood or plasma, certain measures are implemented to prevent transmission of infectious agents to the patient.
These include:

• careful selection of blood and plasma donors to ensure exclusion of those at risk of transmitting infections;
• testing of each individual donation and plasma pools for the presence of viruses or infections;
• implementation of viral removal/inactivation procedures, included by manufacturers during the processing of blood or plasma.

Nevertheless, when administering medicinal products prepared from human blood or plasma, the risk of transmission of infectious agents cannot be completely ruled out.
This applies also to viruses of as yet unknown nature or emerging viruses, and to other pathogens.
There have been no reports of viral infections transmitted following administration of albumin prepared by processes complying with European Pharmacopoeia specifications.
It is strongly recommended that, each time you are administered Albunorm 25%, the name and batch number of the product are recorded, in order to keep a record of batches used.

Other medicines and Albunorm 25%
To date, no interactions between human albumin and other medicinal products have been reported.
However, the Albunorm 25% solution must not be mixed in the same infusion solution with other medicines, whole blood, or concentrated red blood cells.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Human albumin is a normal component of human blood.
No harmful effects are known when this product has been used during pregnancy and breastfeeding. Particular attention must be paid when adjusting blood volume in pregnant women.
Ask your doctor for advice before taking any medicine.

Driving and using machines
There is no evidence that albumin affects the ability to drive or operate machinery.

Albunorm 25% contains sodium
This medicine contains 331–368 mg of sodium (the main component of table salt) per 100 ml of albumin solution. This corresponds to up to 18.4% of the maximum daily intake recommended in an adult's diet.

3. HOW TO USE ALBUNORM 25%

Albunorm 25% is ready for use as an intravenous infusion (drip). The dosage and rate of infusion (how quickly the albumin is administered into your vein) will depend on your individual condition.
Your doctor will determine the most appropriate treatment for you.

Instructions

• The product should be warmed to room or body temperature before use.
• The solution must be clear and free from deposits.
• Any unused solution must be discarded.
• If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you receive more Albunorm 25% than you should:
If the dosage and infusion rate are too high, you may experience headache, elevated blood pressure, and breathing difficulties. The infusion must be stopped immediately, and your doctor will decide whether further treatment is needed.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Adverse reactions following infusion of human albumin are rare and usually disappear when the infusion rate is reduced or upon discontinuation of the infusion.
Rare adverse reactions (occurring in 1 to 10 patients out of 10,000):
Flushing, urticaria, fever, and nausea.
Very rare adverse reactions (occurring in less than 1 patient out of 10,000):
Shock due to hypersensitivity reaction.
Frequency not known (cannot be estimated based on available data):
Confusion; headache; increased or decreased heart rate; increased or decreased blood pressure; sensation of warmth; shortness of breath; nausea; urticaria; swelling around the eyes, nose, or mouth; skin rash; increased sweating; fever; chills.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALBUNORM 25%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and
on the carton after {Exp.}. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the container in the original packaging to protect it from light.
Do not freeze.
Once the container of the solution has been opened, the contents must be
used immediately.
The solution should be clear or slightly opalescent.
Do not use solutions that are cloudy or contain deposits.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. This will help
to protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Albunorm 25% contains
The active substance is human albumin 250 g/l, derived from human plasma.
(Vials of 50 and 100 ml).
The excipients are: sodium chloride, acetyltryptophan, caprylic acid, water for injectable preparations.

Description of the appearance of Albunorm 25% and packaging contents:
Albunorm 25% is an infusion solution in a 50 ml vial (packaged as 1 vial).
Albunorm 25% is an infusion solution in a 100 ml vial (packaged as 1 vial).
The solution is clear, yellow, amber or greenish.
Please note that not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Octapharma Italy S.p.A.
Via Cisanello 145
56124 Pisa
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Albunorm: Italy
Albunorm 25%: Cyprus, Germany, United Kingdom
Albunorm 250 g/l: Austria, Estonia, Finland, France, Hungary, Norway, Romania, Sweden

Manufacturers responsible for batch release

• Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaerstrasse 235, A-1100 Vienna, Austria
• Octapharma S.A.S., 72 rue du Maréchal Foch, F-67380 Lingolsheim, France
• Octapharma AB, Lars Forssells gata 23, SE-112 75 Stockholm, Sweden
• Octapharma Produktionsgesellschaft Deutschland mbH, Wolfgang-Marguerre-Allee 1, D-31832 Springe, Germany