Albiomin

Package leaflet: Information for the user

Albiomin 5% (50 g/l) infusion solution

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Albiomin 5% (50 g/l) is and what it is used for
2. What you need to know before you use Albiomin 5% (50 g/l)
3. How to use Albiomin 5% (50 g/l)
4. Possible side effects
5. How to store Albiomin 5% (50 g/l)
6. Contents of the pack and other information

1. What Albiomin 5% (50 g/l) is and what it is used for

Albiomin 5% (50 g/l) is an infusion solution (into a vein). One litre of solution contains 50 g of human plasma protein, of which at least 96% is human albumin.
Albiomin 5% (50 g/l) is used to restore and maintain circulating blood volume when blood volume is low and the use of a colloid such as albumin is required.

2. What you need to know before using Albiomin 5% (50 g/l)

Do not use Albiomin 5% (50 g/l):

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

Warnings and precautions
If an allergic or anaphylactic reaction is suspected, stop the infusion immediately. In case of shock, implement standard medical treatment for such conditions. The infusion must be stopped if any of the following symptoms of cardiovascular overload (hypervolemia) occur:

• headache
• dyspnea (breathing difficulty)
• jugular vein distension (excess fluid in a neck vein)
• increased arterial pressure
• increased venous pressure (elevated pressure in the veins)
• pulmonary edema (fluid in the lungs)

Consult your doctor if you suffer from any of the following conditions:

• heart failure (decompensated cardiac insufficiency)
• high blood pressure (hypertension)
• enlarged esophageal veins (esophageal varices)
• fluid in the lungs (pulmonary edema)
• tendency to spontaneous and abnormal bleeding (hemorrhagic diathesis)
• severe deficiency of red blood cells (severe anemia)
• reduced or absent urine production (renal and post-renal anuria)
  The doctor will take the necessary precautions. The doctor will monitor circulatory parameters, electrolyte balance, and blood volume.

Information on transmission of infectious agents
For medicines prepared from human blood or plasma, standard measures are taken to prevent the transmission of infections. These include:

• selection of blood and plasma donors, excluding carriers of infections,
• screening of individual donations and plasma pools using specific markers for infections/viruses,
• inclusion in the manufacturing process of viral removal/inactivation procedures.
  Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely excluded. This includes unknown or emerging viruses and other types of infections. There have been no reports of viral infections occurring after administration of albumin manufactured in compliance with the standards set by the European Pharmacopoeia and using the prescribed procedures. Whenever a dose of Albiomin 5% (50 g/l) is administered, it is strongly recommended to record the product name and batch number to allow traceability of the batches used.

For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Other medicines and Albiomin 5% (50 g/l)
Inform your doctor 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 a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Your doctor will decide whether Albiomin 5% (50 g/l) can be used during pregnancy and breastfeeding.
Driving and use of machines
Albiomin 5% (50 g/l) has no known effects on the ability to drive vehicles or operate machinery.
Albiomin 5% (50 g/l) contains sodium
This medicine contains approximately 833 mg of sodium (the main component of table salt) in each 250 ml vial. This corresponds to 41.7% of the maximum daily dietary intake recommended for an adult.

3. How to use Albiomin 5% (50 g/l)

Albiomin 5% (50 g/l) is usually administered in a hospital setting by a doctor or nursing staff.
Human albumin may be administered directly into a vein.
Dosage and frequency of administration
The amount of Albiomin 5% (50 g/l) administered depends on the patient's body weight, the disease condition, and fluid and protein loss.
The doctor will determine the appropriate dose and frequency of administration of Albiomin 5% (50 g/l) required to correct blood parameters.
If you use more Albiomin 5% (50 g/l) than you should
This is unlikely, but if it occurs, the doctor will know how to manage it.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following symptoms:

• skin rash
• itching
• wheezing
• difficulty breathing
• swelling of the eyelids, face, lips, throat or tongue
• extremely low blood pressure with symptoms such as dizziness, confusion, fainting, rapid pulse
  These may be signs of an allergic reaction or, in rare cases, a severe allergic reaction (anaphylactic shock)
  or a hypersensitivity reaction.

The following adverse reactions have been reported with Albiomin 5% (50 g/l) or are known for other
human albumin-containing products:
Not known (frequency cannot be estimated from the available data):

• Hypersensitivity, anaphylactic reaction, anaphylactic shock
• Constriction in the lungs (bronchospasm)
• Increased heart rate (tachycardia)
• Shock
• Nausea
• Skin reactions (flushing, urticaria, itching, erythema, rash)
• Chills
• Fever
• Low blood pressure (hypotension)
• Reduced oxygen saturation
• Leakage at the injection site (extravasation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco)
Website: http://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 Albiomin 5% (50 g/l)

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer packaging.
Keep the vial in the outer packaging to protect the medicine from light.
Do not store above 25°C.
Do not freeze.
Once opened, the product must be used immediately.
Immediately before administration, check that the solution is clear. Do not use the
product if it appears cloudy or contains deposits.
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 Albiomin 5% (50 g/l) contains
Each 250 ml vial of solution contains 12.5 g of human plasma protein, of which at least 96% consists of human albumin.
The other components are: sodium caprylate (4 mmol/l), sodium chloride (130 mmol/l), N-acetyltryptophanate (4 mmol/l), and water for injections.

Description of the appearance of Albiomin 5% (50 g/l) and package contents:
Clear, slightly viscous liquid, almost colourless, yellow, amber, or green
250 ml glass vial

Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich
Germany
Tel.: +49 6103 801-0
Fax: +49 6103 801-150
E-mail: [email protected]

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS:

Special warnings and precautions for use
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.
When relatively large blood volumes are to be replaced, coagulation and haematocrit should be monitored. It is necessary to ensure that other blood components are also adequately replaced (coagulation factors, electrolytes, platelets, and erythrocytes).
If the dose and infusion rate are not adjusted according to the patient's circulatory status, hypervolaemia may occur.

Interactions with other medicinal products and other forms of interaction
No interactions of human albumin with other products are known.

Dosage and method of administration

Dosage
To determine the required dose, refer to parameters indicating adequate circulating volume, rather than plasma albumin levels.
If human albumin is administered, circulatory parameters should be monitored regularly, including:

• arterial blood pressure and pulse
• central venous pressure
• pulmonary artery wedge pressure
• urine output
• electrolytes
• haematocrit/hemoglobin

Method of administration
For intravenous use
Human albumin may be administered directly intravenously.
In the case of plasmapheresis, the infusion rate should be adjusted to match the plasma removal rate.

Instructions for handling
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.
If large volumes are to be administered, warm the product to room temperature or body temperature before use.
The solution should be clear or slightly opalescent. Do not use cloudy solutions or those containing deposits, as this may indicate protein instability or contamination.
Once the vial has been opened, the contents should be used immediately. Any unused product must be disposed of in accordance with local regulations.

Package leaflet: Information for the user

Albiomin 20% (200 g/l) infusion solution

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Albiomin 20% (200 g/l) is and what it is used for
2. What you need to know before using Albiomin 20% (200 g/l)
3. How to use Albiomin 20% (200 g/l)
4. Possible side effects
5. How to store Albiomin 20% (200 g/l)
6. Contents of the pack and other information

1. What Albiomin 20% (200 g/l) is and what it is used for

Albiomin 20% (200 g/l) is an infusion solution (into the vein). 1 litre of solution contains 200 g of human plasma protein, of which at least 96% is human albumin.
Albiomin 20% (200 g/l) is used to restore and maintain circulating blood volume when blood volume is low and the use of a colloid such as albumin is required.

2. What you should know before using Albiomin 20% (200 g/l)

Do not use Albiomin 20% (200 g/l):

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

Warnings and precautions
If there is suspicion of an allergic or anaphylactic reaction, stop the infusion immediately. In case of shock, implement standard medical therapy for such a condition.
The infusion must be stopped if any of the following symptoms of cardiovascular overload (hypervolemia) occur:
headache
dyspnea (difficulty breathing)
jugular vein distension (excess fluid in a neck vein)
increased blood pressure
increased venous pressure (elevated pressure in the veins)
pulmonary edema (fluid in the lungs)

Consult your doctor if you suffer from any of the following conditions:
heart failure (decompensated cardiac insufficiency)
high blood pressure (hypertension)
enlarged esophageal veins (esophageal varices)
fluid in the lungs (pulmonary edema)
tendency to spontaneous or abnormal bleeding (hemorrhagic diathesis)
severe shortage of red blood cells (severe anemia)
reduced or absent urine production (renal and post-renal anuria)

The physician will take the necessary precautions. The physician will monitor the patient's circulatory parameters, electrolyte balance, and blood volume.

Information on transmission of infectious agents
For medicines prepared from human blood or plasma, standard measures are adopted to prevent the transmission of infections. These include:

• selection of blood and plasma donors, excluding carriers of infections,
• screening of individual donations and plasma pools using specific markers for infections/viruses,
• inclusion in the manufacturing process of viral removal/inactivation procedures.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This includes viruses of unknown nature or emerging viruses, as well as other types of infections. There have been no reports of viral infections occurring after administration of albumin manufactured in compliance with the standards set by the European Pharmacopoeia using the prescribed procedures. Every time a dose of Albiomin 20% (200 g/l) is administered, it is strongly recommended to record the product name and batch number to allow traceability of the batches used.

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

Other medicines and Albiomin 20% (200 g/l)
Inform your doctor 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 a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will decide whether Albiomin 20% (200 g/l) can be used during pregnancy and breastfeeding.

Driving and using machines
Albiomin 20% (200 g/l) has no known effects on the ability to drive vehicles or operate machinery.

Albiomin 20% (200 g/l) contains sodium
This medicine contains approximately 140 mg of sodium (the main component of table salt) per 50 ml vial. This corresponds to 7.0% of the maximum daily intake recommended in an adult's diet.
This medicine contains approximately 280 mg of sodium (the main component of table salt) per 100 ml vial. This corresponds to 14.0% of the maximum daily intake recommended in an adult's diet.

3. How to use Albiomin 20% (200 g/l)

Albiomin 20% (200 g/l) is usually administered in a hospital setting by a doctor or nursing staff. Human albumin may be given directly into a vein or diluted in a 0.9% sodium chloride solution.
Dosage and frequency of administration
The amount of Albiomin 20% (200 g/l) administered depends on the patient's body weight, the disease condition, and the loss of fluids and proteins.
The doctor will determine the appropriate dose and frequency of administration of Albiomin 20% required to correct blood parameters.
If you use more Albiomin 20% (200 g/l) than you should
This is unlikely, but if it occurs, the doctor will know what to do.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following symptoms:

• Skin rash
• Itching
• Wheezing
• Difficulty breathing
• Swelling of the eyelids, face, lips, throat or tongue
• Extremely low blood pressure with symptoms such as dizziness, confusion, fainting, rapid pulse

These may be signs of an allergic reaction or, in rare cases, a severe allergic reaction (anaphylactic shock)
or a hypersensitivity reaction.

The following adverse reactions have been reported with Albiomin 20% (200 g/l) or are known for other
human albumin-containing products:
Not known (frequency cannot be estimated from the available data):

• Hypersensitivity, anaphylactic reaction, anaphylactic shock
• Constriction in the lungs (bronchospasm)
• Increased heart rate (tachycardia)
• Shock
• Nausea
• Skin reactions (flushing, urticaria, itching, erythema, rash)
• Chills
• Fever
• Low blood pressure (hypotension)
• Reduced oxygen saturation
• Leakage at the injection site (extravasation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse.
You may also report side effects directly to the Italian Medicines Agency (Agenzia Italiana del Farmaco)
Website: http://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 Albiomin 20% (200 g/l)

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer packaging.
Keep the vial in the outer packaging to protect the medicine from light.
Do not store above 25°C.
Do not freeze.
Once opened, the product must be used immediately.
Immediately before administration, check that the solution is clear. Do not use the product if it appears cloudy or contains deposits.
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 Albiomin 20% (200 g/l) contains
Each 50 ml vial of solution contains 10 g of human plasma protein, of which at least 96% consists of human albumin.
Each 100 ml vial of solution contains 20 g of human plasma protein, of which at least 96% consists of human albumin.
The other components are: sodium caprylate (16 mmol/l), sodium chloride (63 mmol/l), N-acetyltryptophanate (16 mmol/l), and water for injections.

Description of the appearance of Albiomin 20% (200 g/l) and package contents:
Clear, slightly viscous liquid, almost colourless, yellow, amber or green
50 ml glass vial
100 ml glass vial

Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich
Germany
Tel.: +49 6103 801-0
Fax: +49 6103 801-150
E-mail: [email protected]

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS:

Special warnings and precautions for use
The colloidal-osmotic effect of human albumin 20% (200 g/l) is approximately 4 times that of plasma in the blood. Therefore, when administering such albumin concentrations, adequate hydration of the patient must be ensured. Patients must be closely monitored for the risk of circulatory overload and hyperhydration.
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.
If relatively large volumes of blood need to be replaced, coagulation and haematocrit must be monitored. It is necessary to ensure that other blood components are also adequately replaced (coagulation factors, electrolytes, platelets and erythrocytes).
If the dose and infusion rate are not adjusted according to the patient's circulatory status, hypervolaemia may occur.

Interactions with other medicinal products and other forms of interaction
No interactions of human albumin with other medicinal products are known.

Dosage and method of administration

Dosage
To determine the required dose, refer to parameters indicating adequate circulating volume, rather than plasma albumin levels.
If human albumin administration is required, regularly monitor the following circulatory parameters:

• arterial blood pressure and pulse
• central venous pressure
• pulmonary artery wedge pressure
• urine output
• electrolytes
• haematocrit/hemoglobin

Method of administration
For intravenous use.
The solution may be administered directly intravenously or diluted in an isotonic solution (e.g. 0.9% sodium chloride).
In the case of plasmapheresis, the infusion rate of albumin must be matched to the rate of plasma removal.

Handling instructions
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.
If large volumes are to be administered, warm the product to room temperature or body temperature before use.
The solution should be clear or slightly opalescent. Do not use turbid solutions or those containing deposits. These may be signs that the protein is unstable or that the solution is contaminated.
Once the vial has been opened, the contents must be used immediately. Any unused product must be disposed of in accordance with local regulations.