Alburex: detailed information

Package Leaflet: Information for the User

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

Human albumin
Please read this leaflet carefully before receiving 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 you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.

Contents of this leaflet:

What Alburex 5% is and what it is used for
What you need to know before being given Alburex 5%
How to use Alburex 5%
Possible side effects
How to store Alburex 5%
Contents of the pack and other information

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

What Alburex 5% is
Alburex 5% is a plasma substitute.
How Alburex 5% works
Albumin functions to stabilize the circulating blood volume and has the ability to transport hormones, enzymes, drugs, and toxins. The albumin protein in Alburex 5% is derived from human blood plasma. Therefore, the albumin has activity identical to your own natural protein.
What Alburex 5% is used for
Alburex 5% is used for the restoration and maintenance of circulating blood volume. It is typically used in serious medical situations when your blood volume decreases critically. This may occur in cases of:

Significant blood loss following severe injuries, or
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 section carefully. The following information should be considered 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 ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or healthcare professional before you are given Alburex 5%.
Which conditions increase the risk of experiencing side effects?
Your doctor or healthcare professional will pay particular attention if there is an abnormal increase in blood volume (hypervolemia) or dilution of the blood (haemodilution), as this could be dangerous for you.
Examples of such situations include:

heart failure requiring pharmacological treatment (decompensated heart failure)
high blood pressure (hypertension)
oesophageal varices (enlarged veins in the oesophagus)
abnormal accumulation of fluid in the lungs (pulmonary oedema)
tendency to bleeding (haemorrhagic diathesis)
severe reduction in red blood cells (severe anaemia)
significantly reduced urine output due to impaired kidney function or reduced urinary flow (renal or post-renal anuria).

Inform your doctor or healthcare professional before treatment if any of these conditions apply to you.
When might treatment need to be stopped?

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

Inform your doctor or a healthcare professional immediately if such reactions occur during albumin infusion. He or she will decide whether to stop the infusion completely and initiate appropriate treatment.

Excessive increase in blood volume (hypervolemia) may occur if the dose and rate of infusion are not appropriate for your condition. This may lead to overload of the heart and circulatory system (cardiovascular overload). Early signs of such overload include headache, difficulty breathing, or swelling of the neck veins (jugular vein distension). Inform your doctor or a healthcare professional immediately if you notice any of these signs. He or she will stop the infusion and monitor circulation, if necessary. Information on safety regarding infections

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

careful selection of blood or plasma donors to ensure 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 ruled out. This also applies to unknown or emerging viruses and other types of infections.
There are no known cases of viral infections from albumin produced by processes defined according to the requirements of the European Pharmacopoeia.

It is strongly recommended that each time Alburex 5% is administered to you, the name and batch number of the product be recorded to maintain traceability 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 might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you may use Alburex 5% during pregnancy or while breastfeeding.
The use of Alburex 5% during pregnancy or breastfeeding has not been demonstrated in separate controlled clinical studies. However, medicinal products 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 using machines:
No effects on the ability to drive or use machines 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 on a sodium-controlled diet.
“For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.”

3. How to use Alburex 5%

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

Your blood pressure,
Your pulse rate, or
The amount of urine you have produced,
Your blood test results.

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 are given more Alburex 5% than you should receive:
Alburex 5% is administered under strict medical supervision, so overdose is very unlikely. However, an abnormal increase in blood volume (hypervolemia) may occur if the dose and infusion rate are too high. This could lead to overload of the heart and circulatory system (cardiocirculatory overload). Early signs of overload include:

headache,
breathing difficulties, or
swelling of the neck veins (jugular vein distension).

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

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

In all these cases, the infusion will be stopped immediately, and, if necessary, all circulatory parameters will be monitored and managed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects may occur even if you have previously received Alburex 5% and tolerated it well.
General experience with human albumin solutions has shown that the following side effects may occur.

Allergic-type reactions (hypersensitivity reactions) may occur, which very rarely (less than 1 in 10,000 treated patients) can be so severe as to cause shock.
Symptoms of an allergic reaction may include one or more of the following:

skin reactions such as: redness, itching, swelling, blisters, rash, or urticaria (itchy raised skin areas);
breathing difficulties such as: wheezing, chest tightness, shortness of breath, or cough;
swelling of the face, eyelids, lips, tongue, or throat;
feeling cold, runny nose, or sneezing, flushing, itching, swelling, or watering of the eyes;
headache, stomach ache, nausea, vomiting, or diarrhoea.

Inform your doctor immediately if you notice any of these reactions during the infusion of Alburex 5%.
In such a case, the doctor 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 usually 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 has been marketed. However, the exact frequency of these side effects is unknown.

Reporting of side effects
If you experience any side effects, tell your doctor, nurse, or pharmacist, even if they are side effects not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency's (Agenzia Italiana del Farmaco) national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you help provide further information on 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 label of the vial, after the words “Expires on:”. The expiry date refers to the last day of that month.
Once the vial has been opened, the contents should be used immediately.
Do not store above 25°C.
Do not freeze.
Store the vial in the original packaging to protect it from light.
Do not use this medicine if you notice that the solution is cloudy or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Alburex 5% contains

The active substance is human albumin. Alburex 5% is a solution containing 50 g/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-acetyltryptophanate, sodium caprylate, sodium chloride, water for injections.

Description of the appearance of Alburex 5% and contents of the pack
Alburex 5% is a solution for infusion. The solution is clear and slightly viscous, with a colour ranging from almost colourless to yellow, very light brown or green.

Pack sizes: 1 vial per pack (12.5 g/250 mL, 25 g/500 mL). 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 in the Member States of the European Economic Area under the following names:

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, 50 g/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

This Patient Information Leaflet was last approved on:

Package Leaflet: Information for the user

Alburex 20%, 200 g/l, solution for infusion

Human albumin
Please read this leaflet carefully before receiving 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 you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist.

Contents of this leaflet:

What Alburex 20% is and what it is used for
What you need to know before Alburex 20% is administered to you
How to use Alburex 20%
Possible side effects
How to store Alburex 20%
Contents of the pack and other information

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

What Alburex 20% is
Alburex 20% is a plasma substitute.
How Alburex 20% works
Albumin functions to stabilise the volume of circulating blood and has the ability to transport hormones, enzymes, drugs and toxins. The albumin protein in Alburex 20% is derived from human blood plasma. Therefore, albumin has activity identical to your own natural protein.
What Alburex 20% is used for
Alburex 20% is used for the restoration and maintenance of circulating blood volume. It is normally used in serious medical situations when your blood volume has critically decreased. This may occur in cases of:

Major blood loss following severe trauma, or
Extensive burns.
The decision to use Alburex 20% will be made by your doctor and will depend on your clinical condition.

2. What you should know before being given Alburex 20%

Please read this section carefully. The following information must be taken into consideration by you and your doctor before Alburex 20% is administered to you.

Do not use Alburex 20%:

If you are allergic (hypersensitive) to:

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

Warnings and precautions

Talk to your doctor or healthcare professional before Alburex 20% is given to you.

Which circumstances increase the risk of experiencing adverse effects?

Your doctor or healthcare professional will exercise particular caution if:

An abnormal increase in blood volume (hypervolemia) or dilution of the blood (haemodilution) could occur, which might be dangerous for you.

Examples of such situations include:

cardiac insufficiency requiring pharmacological treatment (decompensated heart failure)
high blood pressure (hypertension)
oesophageal varices (enlarged veins in the oesophagus)
abnormal accumulation of fluid in the lungs (pulmonary oedema)
predisposition to bleeding (haemorrhagic diathesis)
severe reduction in red blood cells (severe anaemia)
marked decrease in urine output due to impaired kidney function or reduced urinary flow (renal or post-renal anuria).

Inform your doctor or healthcare professional before treatment if any of these conditions apply to you.

When might treatment need to be stopped?

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 a healthcare professional immediately if such reactions occur during albumin infusion. The doctor will decide whether to stop the infusion completely and initiate appropriate treatment.
Excessive increase in blood volume (hypervolemia) may occur if the dose and infusion rate are not appropriate for your condition. This may lead to cardiovascular overload (cardiovascular overload). Early signs of such overload include headache, difficulty breathing, or swelling of the neck veins (jugular vein distension).

Inform your doctor or healthcare professional immediately if such signs occur. The infusion will be stopped and circulation monitored, if necessary.

Information on safety regarding infections

For medicines derived from human blood or plasma, certain measures are taken to prevent transmission of infections to patients.

These include:

careful selection of blood or plasma donors to exclude 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.

There are no known cases of infections from albumin manufactured according to processes defined by the European Pharmacopoeia requirements.

It is strongly recommended that each time Alburex 20% is administered to you, the product name and batch number are recorded to ensure traceability of the batch used.

Other medicines and Alburex 20%:

No specific interactions between Alburex 20% and other medicines are known.

However, before treatment, inform 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 may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you may use Alburex 20% during pregnancy or while breastfeeding.

The use of Alburex 20% during pregnancy or breastfeeding has not been studied in separate controlled clinical trials. However, medicines containing human albumin have been used during both pregnancy and breastfeeding.

Experience has shown that no harmful effects are expected either during pregnancy or on the foetus or newborn.

Driving and using machines:

No effects on the ability to drive vehicles or use 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 on a sodium-restricted diet.

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

3. How to use Alburex 20%

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

Your blood pressure,
Your pulse rate,
The amount of urine you have produced,
Your blood tests. These parameters are necessary to calculate the correct dose and infusion rate.

Alburex 20% must not be mixed with other medicinal products (except 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, so overdose is very unlikely. However, an abnormal increase in blood volume (hypervolemia) may occur if the dose and infusion rate are too high. This could lead to overload of the heart and circulatory system (cardiocirculatory overload).
Early signs of overload include:

Headache,
Breathing difficulties,
Swelling of the neck veins (jugular vein congestion). Inform your doctor or healthcare professional immediately if you notice these symptoms.

Your doctor or healthcare professional may observe signs such as:

Increased blood pressure,
Increased central venous pressure,
Abnormal fluid accumulation in the lungs (pulmonary edema). In all these cases, the infusion will be stopped immediately, and, if necessary, circulatory parameters will be closely monitored.

5. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. These side effects may occur even if you have previously received Alburex 20% and tolerated it well.
General experience with human albumin solutions has shown that the following side effects may occur.

Allergic-type reactions (hypersensitivity reactions) may occur, which very rarely (less than 1 in 10,000 treated patients) may be so severe as to cause shock.
An allergic reaction may include one or more of the following symptoms:

skin reactions such as: flushing, itching, swelling, blisters, rash or hives;
breathing difficulties such as: wheezing, chest tightness, shortness of breath or cough;
swelling of the face, eyelids, lips, tongue or throat;
feeling cold, runny nose or sneezing, redness, itching, swelling or watering of the eyes;
headache, stomach ache, nausea, vomiting or diarrhoea.

Inform your doctor immediately if you notice any of these types of reactions during the infusion of Alburex 20%. In such a 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 1,000 and 1 in 10,000 treated patients):

skin flushing
skin irritation (urticaria)
fever
nausea

These side effects usually disappear rapidly when the infusion rate is reduced or the infusion is 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, tell your doctor, nurse or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency's national reporting system at the following website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you help provide further information on 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 label of the vial, following the words “Expiry date:”. The expiry date refers to the last day of that month.
Once the vial has been opened, the contents should be used immediately.
Do not store above 25°C.
Do not freeze.
Store the vial in the original outer packaging to protect it from light.
Do not use this medicine if you notice that the solution is cloudy or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Alburex 20% contains

The active substance is human albumin. Alburex 20% is a solution containing 200 g/L of total proteins, of which not less than 96% is human albumin.
One 50 mL vial contains 10 g of human albumin.
One 100 mL vial contains 20 g of human albumin.
Other components are: N-acetyltryptophanate, sodium caprylate, sodium chloride, water for injections.

Description of the appearance of Alburex 20% and contents of the pack
Alburex 20% is a solution for infusion. The solution is clear and slightly viscous, with a colour ranging from almost colourless to yellow, very light brown or green.
Packs: 1 vial per pack (10 g/50 mL, 20 g/100 mL).
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 in the Member States of the European Economic Area under the following names:
Belgium, Luxembourg, Netherlands: Alburex 20, 200 g/l, Oplossing voor infusie / Solution pour perfusion / Infusionslösung
Bulgaria: Албурекс 20, 200 g/l, инфузионен разтвор
Cyprus: Alburex 20, 200 g/l, διάλυμα για ενδοφλέβια έγχυση
Czech Republic, Slovakia: Alburex 20, 200 g/l, infuzní roztok / infúzny roztok
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, soluzione per infusione
Hungary: Alburex 200 g/l, oldatos infúzió
Finland, Norway, Iceland, Sweden: Alburex 200 g/l, infuusioneste, liuos / infusjonsvæske, oppløsning / Eingöngutilnotkunar í bláæð / Infusionsvätska, lösning
Poland: Alburex 20, 200 g/l, roztwór do infuzji
Portugal: Alburex 20, 200 g/l, solução para perfusão
Romania: Alburex 200 g/l, soluţie perfuzabilă
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

This leaflet was last approved on:

Package Leaflet: Information for the User

Alburex 25%, 250 g/L, solution for infusion

Human albumin
Please read this leaflet carefully before receiving this medicine, as it contains
important information for you

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What Alburex 25% is and what it is used for
What you need to know before you are given Alburex 25%
How to use Alburex 25%
Possible side effects
How to store Alburex 25%
Package contents and other information

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

What Alburex 25% is
Alburex 25% is a plasma substitute.
How Alburex 25% works
Albumin functions to stabilize the volume of circulating blood and has the ability to transport hormones, enzymes, drugs, and toxins. The albumin protein in Alburex 25% is derived from human blood plasma. Therefore, the albumin has activity identical to your own natural protein.
What Alburex 25% is used for
Alburex 25% is used for the restoration and maintenance of circulating blood volume. It is typically used in serious medical situations when your blood volume has critically decreased. This may occur in cases such as:

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

2. What you should know before being given Alburex 25%

Please read this section carefully. The following information must be considered 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%.

Which circumstances increase the risk of experiencing adverse effects?

Your doctor or healthcare professional will exercise particular caution if an abnormal increase in blood volume (hypervolemia) or dilution of the blood (hemodilution) occurs, as this could be dangerous for you.

Examples of such situations include:

Heart failure requiring pharmacological treatment (decompensated heart failure)
High blood pressure (hypertension)
Enlarged veins in the esophagus (esophageal varices)
Abnormal accumulation of fluid in the lungs (pulmonary edema)
Tendency to bleed (hemorrhagic diathesis)
Severe reduction in red blood cells (severe anemia)
Markedly reduced urine output due to impaired kidney function or reduced urinary flow (renal or post-renal anuria)

Inform your doctor or healthcare professional before treatment if any of these conditions apply to you.

When might treatment need to be stopped?

Allergic reactions (hypersensitivity reactions) may occur and, very rarely, can be severe enough to cause shock (see section 4 “Possible side effects”).

Immediately inform your doctor or healthcare professional if such reactions occur during albumin infusion. They will decide whether to stop the infusion completely and initiate appropriate treatment.

Excessive increase in blood volume (hypervolemia) may occur if the dose and rate of infusion are not appropriate for your condition. This may lead to overload of the heart and circulatory system (cardiovascular overload). Early signs of such overload include headache, difficulty breathing, or swelling of the neck veins (jugular vein distension). Immediately inform your doctor or healthcare professional if you notice any of these signs. They will stop the infusion and monitor your circulation as needed.

Information on safety regarding infections

For medicines produced from human blood or plasma, certain measures are taken to prevent transmission of infections to patients.

These include:

Careful selection of blood or plasma donors to ensure 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

No cases of viral infections from albumin produced using processes meeting the requirements of the European Pharmacopoeia have been reported.

It is recommended that each time Alburex 25% is administered to you, the product name and batch number be recorded to maintain traceability of the batch used.

Other medicines and Alburex 25%:

No specific interactions between Alburex 25% and other medicines are known.

However, before treatment, inform 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 may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can use Alburex 25% during pregnancy or while breastfeeding.

The use of Alburex 25% during pregnancy or breastfeeding has not been studied in separate controlled clinical trials. However, medicines containing human albumin have been used during both pregnancy and breastfeeding. Experience has shown that no harmful effects are expected either during pregnancy or on the fetus or newborn.

Driving and using machines:

No effects on the ability to drive vehicles or use machinery have been observed with the use of Alburex 25%.

"For athletes: using this medicine without a therapeutic indication constitutes doping and may lead to a positive result in anti-doping tests."

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 on a sodium-controlled diet.

3. How to use Alburex 25%

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

Your blood pressure,
Your pulse rate,
Your urine output,
Your blood test results.

These parameters are necessary to calculate the correct dose and infusion rate.
Alburex 25% must not be mixed with other medicines (except diluting solvents 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, so overdose is very unlikely. An abnormal increase in blood volume (hypervolemia) may occur if the dose and infusion rate are too high. This could lead to overload of the heart and circulatory system (cardiocirculatory overload).
Early signs of overload include:

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

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

increased blood pressure,
increased central venous pressure, or
abnormal fluid accumulation in the lungs (pulmonary edema). In all these cases, the infusion will be immediately stopped and, if necessary, all circulatory parameters will be monitored and managed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects may occur even if you have previously received Alburex 25% and tolerated it well.
General experience with human albumin solutions has shown that the following side effects may occur.

skin reactions such as: redness, itching, swelling, blisters, rash or hives;
breathing difficulties such as: wheezing, chest tightness, shortness of breath or coughing;
swelling of the face, eyelids, lips, tongue or throat;
feeling cold, runny nose or sneezing, flushing, itching, eye swelling or tearing;
headache, stomach ache, nausea, vomiting or diarrhoea.

Inform your doctor immediately if you notice any of these reactions during the infusion of Alburex 25%. In such a case, the doctor or healthcare professional 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 usually disappear rapidly 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.

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 label of the vial, after the words “Exp:”. The expiry date refers to the last day of the month.
Once the vial has been opened, the contents should be used immediately. Do not store above 25°C.
Do not freeze.
Store the vial in the original outer packaging to protect it from light.
Do not use this medicine if you notice that the solution is cloudy or contains particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Alburex 25% contains

The active substance is human albumin. Alburex 25% is a solution containing 250 g/L of total proteins, of which not less than 96% is human albumin.
One 50 mL vial contains 12.5 g of human albumin.
One 100 mL vial contains 25 g of human albumin.
Other components are: N-acetyltryptophanate, sodium caprylate, sodium chloride, water for injections.

Description of the appearance of Alburex 25% and contents of the pack
Alburex 25% is an infusion solution. The solution is clear and slightly viscous, with a colour ranging from almost colourless to yellow, very light brown, or green.
Pack sizes: 1 vial per pack (12.5 g/50 mL, 25 g/100 mL).
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 under the following brand names:
Denmark: Human Albumin CSL Behring 25%
Italy: Alburex 25% 250 g/l, solution for infusion

This summary of product characteristics was last approved on: