Albumeon

Package leaflet: Information for the user

Albumeon, 200 g/l, solution for infusion

Active substance: human albumin
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Albumeon is and what it is used for

What is Albumeon?
Albumeon is a plasma substitute.
How Albumeon works
Albumin stabilizes the circulating blood volume. It acts as a carrier for hormones, enzymes, drugs, and toxins. The albumin protein in Albumeon is derived from human blood plasma. Therefore, albumin functions as if it were our own protein.
What is Albumeon used for?
Albumeon is used to restore and maintain circulating blood volume. It is typically used in intensive care situations when blood volume has drastically decreased. This may occur, for example:

• due to severe blood loss following an injury or
• following extensive superficial burns.
  The decision to use Albumeon will be made by your doctor and will depend on your specific clinical condition.

2. What you should know before taking Albumeon

Read this section carefully, as it contains information that you and your doctor should consider before administering this medicine.
Do not take Albumeon:

• 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
Inform your doctor or pharmacist before taking Albumeon.
Under which circumstances is the risk of adverse effects increased?
Your doctor or pharmacist must pay particular attention if an abnormal increase in blood volume (hypervolemia) or blood dilution (hemodilution) could pose a danger to the patient. Listed below are examples of such clinical conditions:

• heart failure requiring pharmacological treatment (decompensated heart failure)
• high blood pressure (hypertension)
• swelling of the esophageal veins (esophageal varices)
• abnormal accumulation of fluid in the lungs (pulmonary edema)
• predisposition to bleeding (hemorrhagic diathesis)
• severe reduction in red blood cells (severe anemia)
• markedly reduced urine output due to kidney failure or impaired drainage system (renal and post-renal anuria)
  Inform your doctor or pharmacist before treatment if any of these conditions applies to you.

When might it be necessary to stop the infusion?

• Allergic reactions (hypersensitivity reactions) may occur, very rarely with such severity as to cause shock (see also section 4). If you notice these reactions during albumin infusion, inform your doctor or pharmacist immediately. They will decide whether to completely stop the infusion and initiate appropriate treatment.
• An abnormal increase in blood volume (hypervolemia) may occur if dosage and infusion rate are not properly adjusted. This could lead to overload of the heart and circulatory system (cardiocirculatory overload). Early symptoms of such overload include headache, breathing difficulties, or swelling of the neck veins (jugular vein distension). If you notice these symptoms, inform your doctor or pharmacist immediately. They will decide whether to stop the infusion and monitor your circulation as needed.

Viral safety
For medicines derived from human blood or plasma, measures must be taken to prevent transmission of infections to patients, including:

• careful selection of blood or plasma donors to ensure exclusion of individuals at risk of carrying infections;
• testing of each donation and plasma pool for viruses/infections;
• inclusion of manufacturing processes capable of inactivating or eliminating viruses.

Despite these precautions, when administering medicines derived from human blood or plasma, it is not possible to completely exclude the risk of transmitting infections. This also applies to unknown or emerging viruses and other types of infections.
There have been no reports of viral infections associated with albumin manufactured according to the specifications of the European Pharmacopoeia using validated manufacturing processes.
It is strongly recommended to record the name and batch number of the medicine each time a dose of Albumeon is administered, in order to keep track of the batches used.

Other medicines and Albumeon
No specific interactions between Albumeon and other medicines are known. Likewise, harmful effects or interactions are not expected.
Inform your doctor or pharmacist before treatment if you are taking, have recently taken, or might take any other medicines.
Albumeon must not be mixed with other medicines or blood-derived products.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Albumeon during pregnancy or breastfeeding has not been specifically studied.
Nevertheless, medicinal products containing human albumin have been used in pregnant women and during breastfeeding. Clinical experience suggests that harmful effects during pregnancy, or on the fetus and newborn, are unlikely.

Driving and using machines
No effects of Albumeon on the ability to drive vehicles or operate machinery have been observed.

Albumeon contains sodium
50 ml vial
One 50 ml vial of this medicine contains 144 mg of sodium (main component of table/cooking salt). This corresponds to 7.2% of the maximum daily recommended sodium intake for an adult.
100 ml vial
One 100 ml vial of this medicine contains 287.5 mg of sodium (main component of table/cooking salt). This corresponds to 14.4% of the maximum daily recommended sodium intake for an adult.

3. How to take Albumeon

Albumeon is administered by a doctor. Albumeon is intended exclusively for intravenous injection (intravenous infusion).
The doctor will determine the dose of Albumeon to be administered. The amount and rate of infusion depend on individual requirements (see also section 2).
The doctor will regularly monitor important haemodynamic parameters such as:

• blood pressure
• heart rate or
• urine output. These values are monitored to determine the appropriate dose and infusion rate.

What to do in case of an overdose of Albumeon
Albumeon is usually administered only under medical supervision. Therefore, overdose is very unlikely.
An abnormal increase in blood volume (hypervolaemia) 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 symptoms of such overload include:

• headache
• breathing difficulties or
• swelling of the neck veins (jugular vein distension). Inform your doctor immediately if you experience these symptoms.

The doctor may also detect symptoms such as

• increased blood pressure
• increased central venous pressure or
• abnormal fluid accumulation in the lungs (pulmonary oedema). In all these cases, the doctor will stop the infusion and monitor your circulation as needed.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences them. These side effects may occur even if Albumeon has been previously administered and was well tolerated.
The general experience with Human Albumin solutions has shown that the following side effects may occur:
Allergic reactions (hypersensitivity reactions), in very rare cases severe enough to cause shock.
Symptoms of an allergic reaction may include one or more of the following:

• skin reactions, such as flushing, itching, swelling, blisters, rashes or urticaria (itchy swellings of the skin)
• breathing difficulties, such as asthma, chest tightness, shortness of breath or cough
• swelling of the face, eyelids, lips, tongue or throat
• cold-like symptoms, such as nasal congestion or runny nose, sneezing, redness, itching, swelling or watering of the eyes
• headache, stomach ache, nausea, vomiting or diarrhoea.

If you experience any of these symptoms, inform your doctor or pharmacist immediately; they will stop the infusion and initiate appropriate treatment.
The following mild side effects may occur rarely (occurring in up to 1 in 1,000 people):

• skin flushing
• itchy rash (urticaria)
• fever
• nausea

These manifestations usually resolve quickly by reducing or stopping the infusion.

The following serious side effects may occur very rarely (occurring in up to 1 in 10,000 people):

• shock

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Albumeon

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and the carton. The expiry date refers to the last day of that month.
• Store below 25°C.
• Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• After opening the container, the product must be used immediately.
• 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. This will help protect the environment.

6. Package contents and other information

What Albumeon contains

• The active substance is human albumin. Albumeon is a solution containing 200 g/l of total protein, of which at least 96% is human albumin.

A 100 ml vial contains at least 19.2 g of human albumin.
A 50 ml vial contains at least 9.6 g of human albumin.
The other components are sodium caprylate, acetyltryptophanate, sodium chloride,
sodium hydroxide and hydrochloric acid (in small quantities, for pH adjustment), and water for
injections.

Description of the appearance of Albumeon and contents of the pack
Albumeon is an infusion solution. The solution is clear and slightly viscous. It may
appear almost colourless or may have a yellow, amber, or green tint.
Pack contents:
1 vial per pack (50 ml / 100 ml).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
CSL Behring S.p.A.
V.le Del Ghisallo, 20
20151 Milan
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Human Albumin “CSL Behring“20% Infusionslösung
Belgium Human Albumin CSL Behring 200 g/l oplossing voor infusie
Human Albumin CSL Behring 200 g/l solution pour perfusion
Human Albumin CSL Behring 200 g/l Infusionslösung
Bulgaria Human Albumin CSL Behring 200 g/L solution for infusion
Cyprus Albumeon
Croatia Albumeon 200 g/l otopina za infuziju
Denmark Albumin “Behring”
Estonia Human albumin CSL Behring / 200 g/l / infusioonilahus
Finland Albumin Behring
France Albumine Humaine CSL Behring 200 g/L, solution pour perfusion
Germany Albumeon
Greece Albumeon
Ireland Human Albumin CSL Behring / 200 g/l / solution for infusion
Iceland Albumin Behring / 200 g/l / solution for infusion
Latvia Human Albumin CSL Behring 200 g/l solution for infusion
Lithuania Human albumin CSL Behring 200 g/l infuzinis tirpalas
Luxembourg Human Albumin CSL Behring 200 g/l solution pour perfusion
Malta Albumeon® 20, 200 g/l, solution for infusion
Norway Albumin Behring
Netherlands Human Albumin CSL Behring 200 g/l oplossing voor infusie
Poland Human Albumin CSL Behring 200 g/l
Portugal Albumina Humana CSL Behring 200 g/l solução para perfusão
United Kingdom Albumeon 20®, 200 g/l solution for infusion
Czech Republic Human Albumin CSL Behring 200 g/l
Romania ALBUMEON 200 g/l soluție perfuzabilă
Slovakia Human Albumin CSL Behring 200 g/l
Slovenia Humani Albumin CSL Behring 200 g/l raztopina za infundiranje
Spain Albúmina Humana CSL Behring 200 g/l solución para perfusión
Hungary Human Albumin CSL Behring 200 g/l oldatos infuzio