ALBUREX 5 % Инфузионный раствор

Содержание инструкции

1. What is Alburex 5% and what is it used for
2. What you need to know before you are given Alburex 5%
3. How to use Alburex 5%
4. Possible side effects
5. How to store Alburex 5%
6. Package Contents and Other Information
7. What is Alburex 20% and what is it used for
8. What you need to know before you are given Alburex 20%
9. How to use Alburex 20%
10. Possible side effects
11. How to store Alburex 20%
12. Package Contents and Other Information
13. What is Alburex 25% and what is it used for
14. What you need to know before you are given Alburex 25%
15. How to use Alburex 25%
16. Possible side effects
17. How to store Alburex 25%
18. Contents of the pack and other information

Alburex 5%, 50 g/l, solution for infusion
Human albumin

Read this leaflet carefully before you receive 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 nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Alburex 5% and what is it used for

What is Alburex 5%
Alburex 5% is a plasma substitute

How does Alburex 5% work
Albumin has the function of stabilizing the volume of circulating blood and has the ability to
transport hormones, enzymes, drugs and toxins. The albumin protein in Alburex 5% is produced
from human blood plasma. Albumin, therefore, has exactly the same activity as Your own
protein.

What is Alburex 5% used for
Alburex 5% is used in the restoration and maintenance of circulating blood volume. It is
normally used in serious medical situations, when the volume of Your blood decreases in a
critical manner. This can happen in case of:

• Large blood loss following severe injuries, or
• Following extensive burns. The decision to use Alburex 5% will be made by Your doctor and will depend on Your clinical condition.

2. What you need to know before you are given Alburex 5%

Please read this paragraph carefully. The following information must be
taken into consideration, by you and your doctor, before you are given Alburex 5%.

Do not use Alburex 5%:

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

Warnings and precautions
Talk to your doctor or healthcare professional before you are given Alburex 5%
What circumstances increase the risk of side effects?
Your doctor or healthcare professional will pay particular attention if an
abnormal increase in blood volume (hypervolemia) or blood dilution
(hemodilution) were to occur, as this may be dangerous for you.
Examples of these situations are:

• heart failure requiring pharmacological treatment (decompensated heart failure)
• high blood pressure (hypertension)
• expansion of the veins of the esophagus (esophageal varices)
• abnormal accumulation of fluid in the lungs (pulmonary edema)
• predisposition to bleeding (bleeding diathesis)
• severe decrease in red blood cells (severe anemia)
• severe decrease in urine output due to impaired kidney function or decreased urine flow (renal or post-renal anuria).

Tell your doctor or healthcare professional before treatment if one or more of
these conditions apply to you.
When may it be necessary to stop treatment?

• Allergic reactions (hypersensitivity reactions) may occur and, very rarely, may progress to shock (see section 4 “Possible side effects”)

Inform your doctor or healthcare professional immediately if you notice such reactions
during the albumin infusion. They will decide whether to stop the infusion
completely and start appropriate treatment.

• An excessive increase in blood volume (hypervolemia) may occur if the dosage and infusion rate are not appropriate for your condition. This can lead to an overload of the cardiovascular system (cardiovascular overload). The first signs of such an overload are headache, difficulty breathing, or swelling of the veins in the neck (jugular vein congestion). Inform your doctor or healthcare professional immediately if you notice such signs. They will stop the infusion and monitor circulation, if necessary. Safety information regarding infections

In the case of medicines produced from human blood or plasma, certain measures are
taken to prevent the transmission of infections to patients. These include:

• careful selection of blood or plasma donors to ensure the exclusion of those at risk;
• testing of individual donations and plasma pools for the presence of viruses/infections;
• the inclusion of manufacturing processes capable of inactivating or removing viruses.

Despite these measures, when medicines derived from human blood or
plasma are administered, the possibility of transmitting infections cannot be
completely excluded. This also applies to unknown or emerging viruses and other types of
infections.
No cases of viral infections have been reported with albumin produced through processes defined according to the
requirements of the European Pharmacopoeia.

• It is strongly recommended that each time Alburex 5% is administered, the name and preparation number of the product are recorded to maintain a track of the batch used.

Other medicines and Alburex 5%:
No specific interactions of Alburex 5% with other medicines are known.
However, before treatment, inform your doctor or pharmacist if you are taking, have
recently taken or may take any other medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Your
doctor will decide whether you can use Alburex 5% during pregnancy or during the
breastfeeding period.
The use of Alburex 5% during pregnancy or breastfeeding has not been demonstrated in
separate controlled clinical studies. However, medicines containing human albumin have been used
both during pregnancy and breastfeeding. Experience has shown that no harmful effects are
expected either in pregnancy or on the fetus or newborn.

Driving and operating machinery:
No effects on the ability to drive and operate machinery have been observed with the use
of Alburex 5%.

Alburex 5% contains sodium
This medicine contains approximately 3.2 mg of sodium per ml of solution
(140 mmol/l). Your doctor or healthcare professional will take this into account if you are following a
diet restricted in sodium.

“For athletes: the use of the drug without therapeutic necessity constitutes
doping and may still result in a positive anti-doping test”.

3. How to use Alburex 5%

Alburex 5% will be administered to you by your doctor or healthcare professional.
It must be administered only by intravenous infusion (intravenous infusion).
The product should be warmed to room temperature or body temperature before administration.
It is up to the doctor to determine the dose of Alburex 5% that will be given to you. The dosage and rate of
infusion depend on your clinical condition.
The doctor or healthcare professional will regularly monitor some important blood parameters such as:

• Your blood pressure,
• Your pulse rate, or
• How much urine you have produced
• Your blood tests. These parameters are necessary to calculate the correct dose and infusion rate. Alburex 5% must not be mixed with other medicines or plasma derivatives. If you receive more Alburex 5% than you should:Alburex 5% is administered under strict medical supervision and it is therefore very unlikely that an overdose could occur. An abnormal increase in blood volume (hypervolemia) may occur if the dose and infusion rate are too high. This could lead to an overload of the heart and circulatory system (cardiovascular overload). The first signs of overload include:
• headache,
• difficulty breathing, or
• swelling of the veins in the neck (jugular vein congestion).

Inform your doctor or healthcare professional immediately if you notice these symptoms.
The doctor or healthcare professional may notice signs such as:

• an increase in blood pressure,
• an increase in central venous pressure,
• an abnormal accumulation of fluid in the lungs (pulmonary edema).

In all these cases, he/she will immediately stop the infusion and, if necessary, all circulatory parameters will be
monitored.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone
will experience them. These side effects may occur even if you have received
Alburex 5% in the past and tolerated it well.

General experiencewith human albumin solutions has shown that the following
side effects may occur.
Allergic-type reactions (hypersensitivity reaction) may occur, very rarely
(less than 1 in 10,000treated patients), and may be severe enough to cause shock.
Symptoms of an allergic reaction may include one or more of the following symptoms:

• skin reactions such as: redness, itching, swelling, blisters, rash or hives (itchy raised patches on the skin);
• difficulty breathing such as: wheezing, chest tightness, shortness of breath or cough;
• swelling of the face, eyelids, lips, tongue or throat;
• feeling of cold, runny nose or sneezing, redness, itching, swelling of the eyes or tearing;
• headache, stomach pain, nausea, vomiting or diarrhea.

Inform your doctor immediately if you notice
these types of reactions during the infusion of Alburex 5%.
In this case, he/she will immediately stop the infusion and start
appropriate treatment.
The following mild side effects may occur rarely(between 1 in 1,000 and 1 in 10,000
treated patients):

• skin redness
• skin irritation (urticaria)
• fever
• nausea.

These side effects normally disappear quickly when the infusion rate is reduced
or the infusion is stopped.
The same side effects have been observed with Alburex 5% since the medicine was
marketed. However, the exact frequency of these side effects is unknown.

Reporting of side effects
If you experience any side effects, inform your doctor, nurse or pharmacist, even if they are not
listed directly through the national reporting system of the Italian Medicines Agency,
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you will help provide further information regarding the
safety of this medicine.

5. How to store Alburex 5%

• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date stated on the outer packaging and on the bottle label, after the wording “Expires on:” the expiry date refers to the last day of that month.
• Once the bottle is opened, the contents must be used immediately.
• Do not store at a temperature above 25°C
• Do not freeze
• Store the bottle in the original packaging to protect it from light
• Do not use this medicine if you notice that the solution is cloudy or shows particles.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This behaviour will help protect the environment

6. Package Contents and Other Information

What Alburex 5% contains

• The active substanceis human albumin. Alburex 5% is a solution containing 50g/L of total proteins, of which not less than 96% is human albumin.

1 vial of 250 mL contains 12.5 g of human albumin
1 vial of 500 mL contains 25 g of human albumin

• Other components are: N-acetyltryptophan, sodium caprylate, sodium chloride, water for injections. Description of the appearance of Alburex 5% and contents of the packAlburex 5% is an infusion solution. The solution is clear, and slightly viscous. With a color that may vary from almost colorless to yellow, very light brown or green. Pack sizes: 1 vial per pack (12.5g/250mL, 25g/500mL). Not all pack sizes may be marketed. Marketing Authorisation HolderCSL Behring GmbH Emil von Behring-Strasse 76 35041 Marburg Germany This medicinal product has been authorised in the Member States of the European Economic Area for the following designations:

Belgium, Luxembourg, Netherlands: Alburex 5, 50 g/l, Oplossing voor infusie, Solution pour perfusion,
Infusionslösung
Bulgaria: Албурекс 5, 50 g/l, инфузионен разтвор
Cyprus: Alburex 5, 50 g/l, διάλυμα για ενδοφλέβια έγχυση
Slovakia: Alburex 5, 50 g/l, infuzní roztok / infúzny roztok
Denmark: Human Albumin CSL Behring 5%, 50 g/l, Infusionsvæske, opløsning
France: Alburex 50 g/l, solution pour perfusion
Austria, Germany: Alburex 5, 50 g/l, Infusionslösung
Hungary: Alburex 5, 50 g/l, oldatos infúzió
Italy: Alburex 5%, 50 g/l, soluzione per infusione
Finland, Norway, Iceland; Sweden: Alburex 5, 50 g/l, infuusioneste, liuos / infusjonsvæske,
oppløsning/ Eingöngu til notkunar í bláæð/ Infusionsvätska, lösning
Poland: Alburex 5, 50g/l, roztwór do infuzji
Portugal: Alburex 5, 50 g/l, solução para perfusão
Romania: Alburex 5, 50 g/l, soluţie perfuzabilă
Slovenia: Alburex 50 g/l, raztopina za infindiranje
Spain: Alburex 50 g/l, solución para perfusión
United Kingdom, Ireland: Alburex 5, 50 g/l, solution for infusion
Alburex 20%, 200 g/l, solution for infusion
Human albumin

Read this leaflet carefully before you receive 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 nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Alburex 20% is and what it is used for
• 2. What you need to know before Alburex 20% is given to you
• 3. How Alburex 20% is used
• 4. Possible side effects
• 5. How to store Alburex 20%
• 6. Contents of the pack and other information

1. What is Alburex 20% and what is it used for

What is Alburex 20%
Alburex 20% is a plasma substitute.

How does Alburex 20% work
Albumin functions to stabilize blood volume and has the ability to
transport hormones, enzymes, drugs and toxins. The albumin protein in Alburex 20% is produced
from human blood plasma. Albumin, therefore, has exactly the same activity as Your own
protein.

What is Alburex 20% used for
Alburex 20% is used in the restoration and maintenance of circulating blood volume. It is
normally used in serious medical situations, when the volume of Your blood decreases critically. This can happen in case of:

• Significant blood loss following severe injuries, or
• Following extensive burns. The decision to use Alburex 20% will be made by Your doctor and will depend on Your clinical condition.

2. What you need to know before you are given Alburex 20%

Please read this paragraph carefully. The following information must
be taken into consideration by you and your doctor before you are given
Alburex 20%.

Do not use Alburex 20%:
If you are allergic (hypersensitive)

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

Warnings and precautions
Talk to your doctor or healthcare professional before you are given Alburex 20%
What circumstances increase the risk of having undesirable effects?
Your doctor or healthcare professional will pay particular attention if:
an abnormal increase in blood volume (hypervolemia) or a dilution
of the blood (hemodilution) should occur, this could be dangerous for you.
Examples of these situations are:

• heart failure requiring pharmacological treatment (decompensated heart failure)
• high blood pressure (hypertension)
• expansion of the veins of the esophagus (esophageal varices)
• abnormal accumulation of fluid in the lungs (pulmonary edema)
• predisposition to bleeding (bleeding diathesis)
• severe decrease in red blood cells (severe anemia)
• severe decrease in urine output due to impaired kidney function or decreased urine flow (renal or post-renal anuria). Tell your doctor or healthcare professional before treatment if one or more of these conditions apply to you. When may it be necessary to stop treatment?
• Allergic reactions (hypersensitivity reactions) may occur and very rarely may be severe up to causing shock (see section 4 “Possible side effects”). Inform your doctor or healthcare professional immediately if you notice such reactions during albumin infusion. They will decide whether to stop the infusion completely and start appropriate treatment.
• An excessive increase in blood volume (hypervolemia) may occur if the dosage and infusion rate are not suitable for your condition. This can lead to an overload of the cardiovascular system (cardiovascular overload). The first signs of such an overload are headache, difficulty breathing or swelling of the veins in the neck (jugular vein congestion).

Inform your doctor or healthcare professional immediately if you notice such signs. They will
stop the infusion and monitor circulation, if necessary.

Safety information about infections
In the case of medicines produced from human blood or plasma, certain measures
are taken to prevent the transmission of infections to patients.
These include:

• careful selection of blood or plasma donors to ensure the exclusion of those at risk
• testing of individual donations and plasma pools for the presence of viruses / infections.
• inclusion of manufacturing processes capable of inactivating or removing viruses.

Despite these measures, when medicines derived from human blood or
plasma are administered, the possibility of transmitting infections cannot be completely excluded. This
also applies to unknown or emerging viruses and other types of infections.
No cases of infections transmitted by albumin produced through processes defined according to the requirements
of the European Pharmacopoeia have been reported.

• It is strongly recommended that each time Alburex 20% is administered to you, the name and preparation number of the product are recorded to maintain a track of the batch used.

Other medicines and Alburex 20%:
No specific interactions of Alburex 20% with other medicines are known.
However, before treatment, inform your doctor or pharmacist if you are taking, have
recently taken or may take any other medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine. The doctor will decide whether you can use Alburex 20% during pregnancy or
during breastfeeding.
The use of Alburex 20% during pregnancy or lactation has not been demonstrated
in separate controlled clinical studies. However, medicines containing human albumin have been
used both during pregnancy and lactation.
Experience has shown that no harmful effects are expected in pregnancy or on the fetus or
newborn.

Driving and operating machinery:
No effects on the ability to drive and operate machinery have been observed with the use
of Alburex 20%.

Alburex 20% contains sodium
This medicine contains approximately 3.2 mg of sodium per ml of solution
(140 mmol/l). Your doctor or healthcare professional will take this into account if you are following a diet
controlled for sodium.

“For athletes: the use of the drug without therapeutic necessity constitutes
doping and may in any case result in positive anti-doping tests”.

3. How to use Alburex 20%

Alburex 20% will be administered to you by your doctor or healthcare professional.
It must be administered only by intravenous infusion (intravenous
infusion). The product should be warmed to room or body temperature before
administration.
It is the doctor's responsibility to establish the dose of Alburex 20% that will be given to you. The dosage and
infusion rate depend on your clinical condition.
The doctor or healthcare professional will regularly monitor important blood parameters such as:

• Your blood pressure,
• Your pulse rate,
• How much urine you have produced,
• Your blood tests. These parameters are necessary to calculate the correct dose and infusion rate.

Alburex 20% should not be mixed with other medicines (except for diluents such as 5% glucose or 0.9% sodium chloride) or plasma derivatives.

If you are given more Alburex 20% than you should receive:
Alburex 20% is administered under strict medical supervision, and therefore it is very unlikely that
an overdose could occur. An abnormal increase in blood volume (hypervolemia) may
occur if the dose and infusion rate are too high. This could lead to
an overload of the heart and circulatory system (cardiovascular overload).
The first signs of overload are:

• headache,
• difficulty breathing,
• swelling of the veins in the neck (jugular vein congestion). Inform your doctor or healthcare professional immediately if you notice these symptoms.

The doctor or healthcare professional may notice signs such as:

• an increase in blood pressure,
• an increase in central venous pressure,
• an abnormal accumulation of fluid in the lungs (pulmonary edema). In all these cases, he/she will immediately stop the infusion and, if necessary, all circulatory parameters will be monitored.

5. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These side effects can occur even if you have received Alburex 20% in the past and tolerated it well.
General experience with human albumin solutions has shown that the following side effects may occur.
Allergic-type reactions (hypersensitivity reaction) may occur, very rarely
(less than 1 in 10,000treated patients), which may be severe enough to cause shock.
An allergic reaction may include one or more of the following symptoms:

• skin reactions such as: redness, itching, swelling, blisters, rash or hives;
• difficulty breathing such as: wheezing, chest tightness, shortness of breath or cough;
• swelling of the face, eyelids, lips, tongue or throat;
• feeling of cold, runny nose or sneezing, redness, itchy swollen eyes or tearing;
• headache, stomach pain, nausea, vomiting or diarrhea.

Inform your doctor immediately if you notice these types of reactions during the infusion of Alburex 20%.
In this case, your doctor or healthcare professional will immediately stop the infusion and
initiate appropriate treatment.
The following mild side effects may occur rarely(between 1 in 1000 and 1 in 10000
treated patients):

• skin redness
• skin irritation (urticaria)
• fever
• nausea

These side effects usually disappear quickly when the infusion rate is reduced or stopped.
The same side effects have been observed with Alburex 20% since the medicine has been
marketed. However, the exact frequency of these side effects is unknown.

Reporting of side effects
If you experience any side effects, inform your doctor, nurse or pharmacist, even if they are not
listed here, directly through the national reporting system of the Italian Medicines Agency,
Website: http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can contribute to providing further information regarding the
safety of this medicine.

5. How to store Alburex 20%

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer packaging and on the bottle label, after the wording “Expires on:” the expiry date refers to the last day of that month.
• Once the bottle is opened, the contents must be used immediately.
• Do not store at a temperature above 25°C
• Do not freeze
• Store the bottle in the original outer packaging to protect it from light
• Do not use this medicine if you notice that the solution is cloudy or shows particles.
• Do not dispose of any medicine in wastewater or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. This behaviour will help protect the environment

6. Package Contents and Other Information

What Alburex 20% contains

• The active substanceis human albumin. Alburex 20% is a solution containing 200g/L of total proteins, of which at least 96% is human albumin. 1 vial of 50 mL contains 10 g of human albumin. 1 vial of 100 mL contains 20 g of human albumin.
• Other components are: N-acetyltryptophan, sodium caprylate, sodium chloride, water for injections. Description of the appearance of Alburex 20% and contents of the packAlburex 20% is an infusion solution. The solution is clear and slightly viscous. With a color that may vary from almost colorless to yellow, very light brown or green. Pack sizes: 1 vial per pack (10 g/50mL, 20 g/100mL). Not all pack sizes may be marketed. Marketing Authorisation HolderCSL Behring GmbH Emil von Behring-Strasse 76 35041 Marburg Germany

This medicinal product has been authorised in the Member States of the European Economic Area for the following designations:
Belgium, Luxembourg, Netherlands: Alburex 20, 200 g/l, Oplossingvoorinfusie/Solution pour perfusion/Infusionslösung
Bulgaria: Албурекс 20, 200 g/l, инфузионенразтвор
Cyprus: Alburex 20, 200 g/l, διάλυμαγιαενδοφλέβιαέγχυση
Czech Republic, Slovakia: Alburex 20, 200 g/l, infuzníroztok / infúznyroztok
Denmark: Human Albumin CSL Behring 20%
France: Alburex 200 g/l, solution pour perfusion
Austria, Germany: Alburex 20, 200 g/l, Infusionslösung
Italy: Alburex 20%, 200 g/l, solution for infusion
Hungary: Alburex 200 g/l, oldatosinfúzió
Finland, Norway, Iceland, Sweden: Alburex 200 g/l, infuusioneste, liuos/ infusjonsvæske, oppløsning/ Eingöngutilnotkunar í bláæð/ Infusionsvätska, lösning
Poland: Alburex 20, 200g/l, roztwór do infuzji
Portugal: Alburex 20, 200 g/l, solução para perfusão
Romania: Alburex 200 g/l, soluţieperfuzabilă
Slovenia: Alburex 200 g/l, raztopina za infindiranje
Spain: Alburex 200 g/l, solución para perfusión
United Kingdom, Ireland: Alburex 20, 200 g/l, solution for infusion
Alburex 25%, 250 g/L, solution for infusion
Human albumin

Read this leaflet carefully before you receive 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 nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Alburex 25% is and what it is used for
• 2. What you need to know before you are given Alburex 25%
• 3. How to use Alburex 25%
• 4. Possible side effects
• 5. How to store Alburex 25%
• 6. Contents of the pack and other information

1. What is Alburex 25% and what is it used for

What is Alburex 25%
Alburex 25% is a plasma substitute.

How does Alburex 25% work
Albumin functions to stabilize blood volume and has the ability to
transport hormones, enzymes, drugs and toxins. The albumin protein in Alburex 25% is produced from
human blood plasma. Albumin, therefore, has exactly the same activity as your own
protein.

What is Alburex 25% used for
Alburex 25% is used in the restoration and maintenance of circulating blood volume. It is
normally used in serious medical situations, when your blood volume decreases critically. This can happen in case of:

• Significant blood loss following severe injuries, or
• Following extensive burns. The decision to use Alburex 25% will be made by your doctor and will depend on your clinical condition.

2. What you need to know before you are given Alburex 25%

Please read this paragraph carefully. The following information must
be taken into consideration, by you and your doctor, before you are given Alburex
25%.

Do not use Alburex 25%:

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

Warnings and precautions
Talk to your doctor or healthcare professional before you are given Alburex 25%
Under what circumstances is the risk of adverse effects increased?
Your doctor or healthcare professional will pay particular attention if an
abnormal increase in blood volume (hypervolemia) or blood dilution
(hemodilution) should occur, as this could be dangerous for you.
Examples of these situations are:

• heart failure requiring pharmacological treatment (decompensated heart failure)
• high blood pressure (hypertension)
• expansion of the veins of the esophagus (esophageal varices)
• abnormal accumulation of fluid in the lungs (pulmonary edema)
• predisposition to bleeding (bleeding diathesis)
• severe decrease in red blood cells (severe anemia)
• severe decrease in urine output due to impaired kidney function or decreased urine flow (renal or post-renal anuria). Tell your doctor or healthcare professional before treatment if one or more of these conditions apply to you. When may it be necessary to stop treatment?
• Allergic reactions (hypersensitivity reactions) may occur and, very rarely, may be severe enough to cause shock (see section 4 “Possible side effects”)

Inform your doctor or healthcare professional immediately if you notice such reactions
during the albumin infusion. They will decide whether to stop the infusion
completely and start appropriate treatment.

• An excessive increase in blood volume (hypervolemia) may occur if the dosage and infusion rate are not appropriate for your condition. This can lead to an overload of the cardiovascular system (cardiovascular overload). The first signs of such an overload are headache, difficulty breathing, or swelling of the veins in the neck (jugular vein congestion). Inform your doctor or healthcare professional immediately if you notice such signs. They will stop the infusion and monitor circulation, if necessary. Safety information about infections

In the case of medicines produced from human blood or plasma, certain measures
are taken to prevent the transmission of infections to patients.
These include:

• careful selection of blood or plasma donors to ensure the exclusion of those at risk
• testing of individual donations and plasma pools for the presence of viruses/infections.
• the inclusion of manufacturing processes capable of inactivating or removing viruses. Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infections cannot be completely excluded. This also applies to unknown or emerging viruses and other types of infections. No cases of viral infections have been reported from albumin produced through processes defined according to the requirements of the European Pharmacopoeia.

It is recommended that each time Alburex 25% is administered, the
name and preparation number of the product are recorded to maintain a track of the batch used.

Other medicines and Alburex 25%:
No specific interactions of Alburex 25% with other medicines are known.
However, before treatment, tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine. The doctor will decide whether you can use Alburex 25% during pregnancy
or during breastfeeding.
The use of Alburex 25% during pregnancy or breastfeeding has not been demonstrated
in separate controlled clinical studies. However, medicines containing human albumin have been
used both during pregnancy and breastfeeding. Experience has shown that no
harmful effects are expected either during pregnancy or on the fetus or newborn.

Driving and operating machinery:
No effects on the ability to drive and operate machinery have been observed with the use
of Alburex 25%.

“For athletes: the use of the drug without therapeutic need constitutes
doping and may still result in a positive anti-doping test”.
Alburex 25% contains sodium
This medicine contains approximately 3.2 mg of sodium per ml of solution
(140 mmol/l). Your doctor or healthcare professional will take this into account if you are following a diet
controlled for sodium.

3. How to use Alburex 25%

Alburex 25% will be administered to you by your doctor or healthcare professional.
It must be performed only by intravenous infusion (intravenous infusion). The product
should be warmed to room or body temperature before administration.
It is up to the doctor to establish the dose of Alburex 25% that will be given to you. The dosage and infusion rate
depend on your clinical condition.
The doctor or healthcare professional will regularly monitor some important blood parameters such as:

• Your blood pressure,
• Your pulse rate,
• How much urine you have produced,
• Your blood tests.

These parameters are necessary to calculate the correct dose and infusion rate.
Alburex 25% should not be mixed with other medicines (except for diluents such as 5% glucose or 0.9% sodium chloride) or plasma derivatives.

If you are given more Alburex 25% than you should receive:
Alburex 25% is normally administered under strict medical supervision and it is therefore very
unlikely that an overdose could occur. An abnormal increase in blood volume
(hypervolemia) may occur if the dose and infusion rate are too high. This
could lead to an overload of the heart and circulatory system (cardiocirculatory overload).
The first signs of overload are:

• headache,
• difficulty breathing,
• swelling of the neck veins (jugular vein congestion).

Inform your doctor or healthcare professional immediately if you notice these symptoms.
The doctor or healthcare professional may notice signs such as:

• an increase in blood pressure,
• an increase in central venous pressure, or
• an abnormal accumulation of fluid in the lungs (pulmonary edema). In all these cases, he/she will immediately stop the infusion and, if necessary, all circulatory parameters will be monitored.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These side effects can occur even if you have received Alburex 25% in the past and tolerated it well.
General experience with human albumin solutions has shown that the following side effects may occur.
Allergic-type reactions (hypersensitivity reaction) may occur, which, very rarely
(less than 1 in 10,000treated patients), can be severe enough to cause shock.
An allergic reaction may include one or more of the following symptoms:

• skin reactions such as: redness, itching, swelling, blisters, rash or hives;
• difficulty breathing such as: wheezing, chest tightness, shortness of breath or cough;
• swelling of the face, eyelids, lips, tongue or throat;
• feeling of cold, runny nose or sneezing, redness, itchy swollen eyes or tearing;
• headache, stomach pain, nausea, vomiting or diarrhea. Inform your doctor immediately if you notice these types of reactions during the infusion of Alburex 25%. In this case, the doctor or healthcare professional will immediately stop the infusion and start appropriate treatment. The following mild side effects can occur rarely(between 1 in 1,000 and 1 in 10,000 treated patients):
• skin redness
• skin irritation (urticaria)
• fever
• nausea

These side effects usually disappear quickly when the infusion rate is reduced
or the infusion is stopped.
The same side effects have been observed with Alburex 25% since the medicine has been
marketed. However, the exact frequency of these side effects is unknown.

Reporting of side effects
If you experience any side effects, inform your doctor, nurse or pharmacist, even if they are not listed here, or report them directly through the national reporting system of the Italian Medicines Agency (Agenzia Italiana del
Farmaco), Website: http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide further information regarding the
safety of this medicine.

5. How to store Alburex 25%

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer packaging and on the bottle label, after the wording “Expires on:” the expiry date refers to the last day of the month.
• Once the bottle has been opened, the contents must be used immediately. Do not store at a temperature above 25°C.
• Do not freeze.
• Store the bottle in the original outer packaging to protect it from light.
• Do not use this medicine if you notice that the solution is cloudy or shows particles.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This behaviour will help to protect the environment.

6. Contents of the pack and other information

What Alburex 25% contains

• The active ingredient is human albumin. Alburex 25% is a solution containing 250g/L of total proteins, of which not less than 96% is human albumin. 1 bottle of 50 mL contains 12.5 g of human albumin. 1 bottle of 100 mL contains 25 g of human albumin.
• Other components are: N-acetyltryptophan, sodium caprylate, sodium chloride, water for injections. Description of the appearance of Alburex 25% and contents of the packAlburex 25% is an infusion solution. The solution is clear and slightly viscous. With a colour that may vary from almost colourless to yellow, very light brown or green. Packs: 1 bottle per pack (12.5g/50mL, 25g/100mL). Not all pack sizes may be marketed.

Marketing Authorisation Holder
CSL Behring GmbH
Emil von Behring-Strasse 76
35041 Marburg
Germany
This medicinal product has been authorised for sale in the following EEA Member States and
with the following trade names:
Denmark: Human Albumin CSL Behring 25%
Italy: Alburex 25% 250 g/l, solution for infusion