ALBUNORM 5% Roztwór do infuzji

Treść ulotki

1. Albunorm 5%
   1. WHAT IS ALBUNORM 5% AND WHAT IS IT USED FOR?
   2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ALBUNORM 5%
   3. HOW TO ADMINISTER ALBUNORM 5%
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ALBUNORM 5%
   6. PACKAGE CONTENTS AND OTHER INFORMATION.
2. Albunorm 20%
   1. WHAT IS ALBUNORM 20% AND WHAT IS IT USED FOR?
   2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ALBUNORM 20%
   3. HOW TO TAKE ALBUNORM 20%
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ALBUNORM 20%
   6. PACKAGE CONTENTS AND OTHER INFORMATION.
3. Albunorm 25%
   1. WHAT IS ALBUNORM 25% AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALBUNORM 25%
   3. HOW TO ADMINISTER ALBUNORM 25%
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ALBUNORM 25%
   6. CONTENTS OF THE PACK AND OTHER INFORMATION.

Albunorm 5%

“50g/l, solution for infusion”
Human albumin

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you are given Albunorm 5%
• 3. How Albunorm 5% is given
• 4. Possible side effects
• 5. How to store Albunorm 5%
• 6. Contents of the pack and other information.

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

Albunorm 5% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions.
The product is given to patients to restore and maintain blood volume
when a volume deficiency is demonstrated.

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ALBUNORM 5%

Do not receive Albunorm 5%:

• if you are allergic to albumin-based 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 you receive 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, dilation of esophageal veins, pulmonary edema, coagulation disorders, severe anemia, or urinary retention.
• when symptoms of increased blood volume (headache, difficulty breathing, congestion of the jugular veins) or increased blood pressure occur. The infusion must be stopped immediately.
• when symptoms of an allergic reaction occur. The infusion must be stopped immediately.
• when it is 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 the transmission of infectious agents to
the patient.
These include:
careful selection of plasma and blood donors to ensure that those at risk of transmitting infections are excluded.
analysis of each donation and plasma pools for the presence of viruses or
infections.
implementation of viral removal/inactivation procedures, including those used by manufacturers
during the processing of blood or plasma.
Despite this, when medicinal specialties prepared from human blood or
plasma are administered, the risk of transmission of infectious agents cannot be completely excluded.
This also applies to viruses of unknown or emerging nature and other pathogens.
There have been no reports of viral infections transmitted following the administration of
albumin prepared using processes established according to the European Pharmacopoeia specifications.
It is strongly recommended that the name and batch number of the product are recorded each time you are given Albunorm 5%, in order to keep track of the batches
used.

Other medicines and Albunorm 5%.
To date, no interactions of human albumin with other products have been reported.
However, the Albunorm 5% solution should not be mixed in the same infusion solution with other medicines, whole blood or concentrated red blood cells.
Tell 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 care should be taken when regulating
blood volume in pregnant women.
Ask your doctor for advice before taking any medicine.

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

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 is equivalent to up to 18.4%
of the maximum recommended daily intake of salt with the diet of an adult.

3. HOW TO ADMINISTER ALBUNORM 5%

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

• The product must be brought to room or body temperature before use.
• The solution must be clear and must not contain any deposits.
• Unused solution must be discarded.
• If you have any doubts about the use of this medicine, please contact your doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects following the infusion of human albumin are rare and
usually disappear when the infusion rate is reduced or with its
discontinuation.

Rare side effects(between 1 and 10 patients per 10,000):
Hot flushes, urticaria, fever and nausea.

Very rare side effects(less than 1 patient per 10,000):
Shock due to hypersensitivity reaction.

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

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more 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 which is stated on the label and
on the packaging after {Scad.}. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect it from light.
Do not freeze.
Once the solution container 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 should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION.

What Albunorm 5% contains
The active ingredient is constituted by 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 package contents:
Albunorm 5% is an infusion solution in a vial of 100 ml (pack of 1
vial and 10 vials).
Albunorm 5% is an infusion solution in a vial of 250 ml (pack of 1
vial and 10 vials).
Albunorm 5% is an infusion solution in a vial of 500 ml (pack of 1
vial).
The solution is clear, yellow, amber or green.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Octapharma Italy S.p.A.
Via Cisanello 145
56124 Pisa
Italy

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations:

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

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

Albunorm 20%

“200 g/l, solution for infusion”
Human albumin

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you are given Albunorm 20%
• 3. How Albunorm 20% is given
• 4. Possible side effects
• 5. How to store Albunorm 20%
• 6. Contents of the pack and other information.

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

Albunorm 20% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions.
The product is given to patients to restore and maintain blood volume
when a volume deficiency is demonstrated.

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ALBUNORM 20%

Do not receive Albunorm 20%:

• if you are allergic to preparations based on 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 you receive Albunorm 20%.

Take special care with Albunorm 20%:

• if you are particularly at risk in case of an increase in blood volume, for example in case of severe heart disease, arterial hypertension, dilation of the veins of the esophagus, pulmonary edema, coagulation disorders, severe anemia, or urinary retention.
• when symptoms of increased blood volume (headache, difficulty breathing, congestion of the jugular veins) or increased blood pressure occur. The infusion must be stopped immediately,
• when symptoms of an allergic reaction occur, the infusion must be stopped immediately.
• when it is 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 plasma and blood donors to ensure that those at risk of transmitting infections are excluded.
analysis of each donation and plasma pools for the presence of viruses or
infections.
Implementation of viral removal/inactivation procedures, including by manufacturers
during the processing of blood or plasma.
Despite this, when medicinal specialties prepared from human blood or
plasma are administered, the risk of transmission of infectious agents cannot be completely excluded.
This also applies to viruses of unknown or emerging nature and other pathogens.
There are no reports of viral infections transmitted following the administration of
albumin prepared with processes established according to the specifications of the European Pharmacopoeia.
It is strongly recommended that each time you are given Albunorm 20%, the
name and batch number of the product are recorded in order to keep track of the batches
used.

Other medicines and Albunorm 20%
To date, no interactions of human albumin with other products have been reported.
However, the Albunorm 20% solution should not be mixed in the same
infusion solution with other medicines, whole blood or concentrated red blood cells.
Tell 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 adverse effects are known when this product has been used during
pregnancy and breastfeeding. Particular care should be taken in regulating the
blood volume in pregnant women.
Ask your doctor for advice before taking any medicine.

Driving and using machines
There is no evidence that albumin alters 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 is equivalent to up to 18.4 %
of the maximum recommended daily intake with the diet of an adult.

3. HOW TO TAKE ALBUNORM 20%

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

• The product must be brought to room or body temperature before use.
• The solution must be clear and must not contain any deposits.
• Unused solution must be discarded.
• If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects following the infusion of human albumin are rare and
usually disappear when the infusion rate is reduced or with its
discontinuation.

Rare side effects(may affect up to 1 in 10,000 people):
Hot flushes, urticaria, fever and nausea

Very rare side effects(may affect up to 1 in 10,000 people):
Shock due to hypersensitivity reaction

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

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, please tell your doctor or pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects
you can help provide more 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 which is reported on the label and
on the packaging after {Scad.}. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect it from light.
Do not freeze.
Once the solution container has been opened, the contents must be
used immediately.
The solution should be clear or slightly opalescent.
Do not use turbid solutions or those with deposits.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION.

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

Description of the appearance of Albunorm 20% and contents of the pack:
Albunorm 20% is an infusion solution in a 50 ml vial (pack of 1
vial and 10 vials).
Albunorm 20% is an infusion solution in a 100 ml vial (pack of 1
vial and 10 vials).
The solution is clear, yellow, amber or green.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the Member States of the European
Economic Area with the following denominations:

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

Manufacturers responsible 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

Albunorm 25%

“250 g/l, solution for infusion”
Human albumin

Read this leaflet carefully before you start to use 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 pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you are given Albunorm 25%
• 3. How Albunorm 25% is given
• 4. Possible side effects
• 5. How to store Albunorm 25%
• 6. Contents of the pack and other information

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

Albunorm 25% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions.
The product is given to patients to restore and maintain circulating blood volume when a volume deficiency is demonstrated.

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

Do not take Albunorm 25%:
if you are allergic to preparations based on 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 taking Albunorm 25%.

Pay particular attention 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, dilation of esophageal veins, pulmonary edema, coagulation disorders, severe anemia, or urinary retention.
• when symptoms of increased blood volume (headache, difficulty breathing, congestion of the jugular veins) or increased blood pressure occur. The infusion must be stopped immediately.
• when symptoms of an allergic reaction occur. The infusion must be stopped immediately.
• when it is 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 the transmission of infectious agents to the patient.
These include:
careful selection of plasma and blood donors to ensure exclusion of those at risk of transmitting infections.
analysis of each donation and plasma pools for the presence of viruses or infections.
Implementation of viral removal/inactivation procedures, including by manufacturers during blood or plasma processing.
Despite this, when administering medicinal specialties prepared from human blood or plasma, the risk of transmission of infectious agents cannot be completely excluded.
This also applies to viruses of currently unknown or emerging nature and other pathogens.
There are no reports of viral infections transmitted following the administration of albumin prepared with processes established according to the specifications of the European Pharmacopoeia.
It is strongly recommended that you record the name and batch number of the product each time you are administered Albunorm 25%, in order to keep track of the batches used.

Other medicines and Albunorm 25%.
To date, no interactions of human albumin with other 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.
Tell 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 adverse effects are known when this product has been used during pregnancy and breastfeeding. Particular care should be taken in regulating blood volume in pregnant women.
Ask your doctor for advice before taking any medicine.

Driving and operating machinery
There is no evidence that albumin alters 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 is equivalent to up to 18.4% of the maximum recommended daily intake with the diet of an adult.

3. HOW TO ADMINISTER ALBUNORM 25%

Albunorm 25% is ready for use as an infusion (drip) into a vein. The dosage and
infusion rate (how quickly the albumin is administered into the vein)
will depend on your specific condition.
Your doctor will determine the best treatment for you.
Instructions

• The product must be brought to room or body temperature before use.
• The solution must be clear and must not contain any deposits.
• Unused solution must be discarded.
• If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you take more Albunorm 25% than you should:
If the dosage and infusion rate are too high, you may experience headache,
increased blood pressure and difficulty breathing. The infusion must be
stopped immediately and your doctor will decide if further
treatment is necessary.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects following the infusion of human albumin are rare and
usually disappear when the infusion rate is reduced or with its
discontinuation.

Rare side effects(may affect up to 1 in 10,000 people):
Hot flushes, urticaria, fever and nausea.

Very rare side effects(may affect up to 1 in 10,000 people):
Shock due to hypersensitivity reaction

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects 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 which is stated on the label and
on the packaging after {Scad.}. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect it from light.
Do not freeze.
Once the solution container 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 should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

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

Description of the appearance of Albunorm 25% and contents of the pack:
Albunorm 25% is an infusion solution in a vial of 50 ml (pack of 1
vial).
Albunorm 25% is an infusion solution in a vial of 100 ml (pack of 1
vial).
The solution is clear, yellow, amber or green.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations:

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