Albutein

Package leaflet: Information for the user

Albutein 50 g/l solution for infusion, 200 g/l solution for infusion, 250 g/l solution for infusion

Human albumin from human plasma
Please read this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT ALBUTEIN IS AND WHAT IT IS USED FOR

ALBUTEIN is an intravenous infusion solution containing proteins extracted from human plasma,
which is the liquid component of blood. In this product, more than 95% of the human plasma proteins
consist of albumin, at a concentration of 5, 20 or 25%, expressed as weight/volume ratio.
ALBUTEIN belongs to a group of medicines known as “Blood substitutes and plasma protein fractions”.
ALBUTEIN is used to restore and maintain circulating blood volume in patients who have lost blood and/or body fluids for any reason, when the use of a colloid (plasma substitute) is appropriate.
The physician may decide to use albumin rather than an artificial colloid based on the individual patient's clinical condition and according to official recommendations.

2. WHAT YOU SHOULD KNOW BEFORE USING ALBUTEIN

Do not use ALBUTEIN
If you are allergic (hypersensitive) to human albumin or to any of the other components of this
medicinal product (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ALBUTEIN.
If you experience, or have previously experienced, symptoms of an allergic reaction (hypersensitivity)
to human albumin, such as difficulty breathing or feeling weak, inform your doctor or nurse
immediately. Suspected allergic or anaphylactic reactions (symptoms of which may include swelling
of the face, lips, and throat, shortness of breath, feeling faint, respiratory failure, itching, or redness)
require immediate discontinuation of the infusion. In case of shock, standard medical treatments for
shock must be initiated.

Albumin should be administered with caution in conditions where hypervolemia (increased blood
volume) and its consequences, or hemodilution (i.e., blood dilution), may pose a particular risk to you.
If you suffer from any of the following conditions, inform your doctor:

• Decompensated heart failure (reduced cardiac performance)
• Hypertension (elevated blood pressure)
• Esophageal varices (dilated veins in the esophagus)
• Pulmonary edema (fluid accumulation in the lungs)
• Hemorrhagic diathesis (predisposition to bleeding)
• Severe anemia (deficiency in red blood cells and/or oxygen-carrying substance)
• Renal and post-renal anuria (absence of urine production)

These conditions may preclude the use of ALBUTEIN in your treatment, or may prompt your doctor to
adjust the dose or infusion rate to avoid complications.

In a 200 g/l or 250 g/l human albumin solution, the concentration is higher than in plasma. Therefore,
when concentrated albumin is administered, your doctor must ensure you are adequately hydrated and
must monitor you closely to prevent circulatory overload and hyperhydration (i.e., heart and circulation
problems due to fluid accumulation).

Moreover, human albumin solutions with a concentration of 200–250 g/l, such as ALBUTEIN, have a
relatively low electrolyte (salt) content compared to human albumin solutions with a concentration of
40–50 g/l. Therefore, your doctor must monitor your electrolyte status (blood salt concentration) and
take appropriate measures to restore or maintain electrolyte balance (see section “The following
information is intended exclusively for physicians or healthcare professionals”).

Concentrated albumin solutions must not be diluted with water for injection, as this may cause hemolysis
(destruction of red blood cells) in recipients.

If relatively large volumes need to be replaced, your doctor must monitor coagulation parameters and
hematocrit (the proportion of blood cells in the blood). Your doctor will take all necessary measures to
adequately replenish blood components (coagulation factors, electrolytes, platelets, and red blood
cells).

If the dose and infusion rate are not adjusted according to your circulatory status, you may experience
symptoms indicating increased blood volume (hypervolemia). If you notice any of the following
symptoms, inform your doctor immediately, as the infusion must be stopped promptly: headache,
dyspnea (difficulty breathing), jugular vein distension (swelling of the veins running down the neck),
increased blood pressure, increased venous pressure, or pulmonary edema.

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

Viral safety
When medicines are manufactured from human blood or plasma, specific measures are taken to prevent
transmission of infections to patients. These measures include:

• careful selection of blood and plasma donors to ensure potentially infected donors are excluded,
• testing of each donation and plasma pool for the presence of viruses/infections,
• inclusion of steps in the manufacturing process capable of inactivating or removing viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, the
possibility of transmitting infectious agents cannot be completely excluded. This also applies to
emerging or unknown viruses or other infectious agents.

No cases of viral transmission have been reported with albumin manufactured using well-established
processes and meeting European Pharmacopoeia specifications.

It is strongly recommended that each time you receive a dose of ALBUTEIN, both the product name and
batch number are recorded, to ensure traceability of the batch used.

Other medicines and ALBUTEIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.

No specific interactions between albumin and other medicines are known.

Incompatibilities: ALBUTEIN must not be mixed with other medicinal products (except for the diluents
recommended in the section “The following information is intended exclusively for physicians or
healthcare professionals”), nor with whole blood or red blood cell concentrates.

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 taking this medicine.

The safety of using ALBUTEIN during pregnancy has not been established in controlled clinical studies.
However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy,
the fetus, or the newborn are expected.

No animal reproductive studies have been conducted with ALBUTEIN. However, albumin is a normal
constituent of human blood.

In general, particular caution should be exercised when performing plasma volume replacement in a
pregnant patient.

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

ALBUTEIN contains sodium
Patients on a sodium-restricted diet should be aware that ALBUTEIN 50 g/l contains 833.8 mg (36.3 mmol) of sodium per 250 ml vial and 1667.5 mg (72.5 mmol) of sodium per 500 ml vial; and that ALBUTEIN 200 g/l and ALBUTEIN 250 g/l contain 166.8 mg (7.3 mmol) of sodium per 50 ml vial.

ALBUTEIN contains very low amounts of potassium and can therefore be considered “potassium-free”.

3. HOW TO USE ALBUTEIN

ALBUTEIN is a product intended for hospital use. It will be administered to you as an intravenous infusion by healthcare professionals and must not be self-administered.
Your doctor will decide how much product you will receive, the infusion rate, frequency, and duration of treatment with ALBUTEIN. All of this will be determined based on your clinical condition.
If you use more ALBUTEIN than you should
If you have been given more ALBUTEIN than required, contact your doctor or pharmacist immediately.
If you forget to use ALBUTEIN
Contact your doctor or pharmacist immediately and follow their instructions.
Do not take a double dose to make up for a missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If you experience any of the following adverse reactions, contact your doctor immediately or go to the nearest hospital:

• Severe reactions such as anaphylactic shock. In such cases, the infusion must be stopped and appropriate treatment initiated. These reactions may occur very rarely.

Other adverse reactions:

• Skin redness
• Skin rashes
• Fever
• Nausea
• Chills
• Hypotension (low blood pressure)

These mild reactions may occur rarely and usually disappear quickly by slowing down or stopping the infusion rate.
For information on viral safety, see section 2, “WHAT YOU SHOULD KNOW BEFORE USING ALBUTEIN”.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report adverse reactions directly via
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALBUTEIN

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 the carton after "Exp.".
The expiry date refers to the last day of that month.
Store below 30°C. Do not freeze.
Keep the vial in the outer packaging to protect it from light.
The solution should be clear or slightly opalescent. Do not use this medicine if you notice that the solution is cloudy or contains deposits. The presence of cloudiness or deposits may indicate that the protein is unstable or that the solution has been contaminated.
Once the container has been opened, the contents must be used immediately.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ALBUTEIN contains

• The active substance is human albumin. One litre of ALBUTEIN contains 50, 200 or 250 g of human plasma proteins, depending on the concentration, of which at least 95% consists of human albumin.
• The other components are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate and water for injections.

For further information on excipients, see also section 2 “WHAT YOU SHOULD KNOW
BEFORE USING ALBUTEIN”.

Description of the appearance of ALBUTEIN and contents of the pack

ALBUTEIN is an infusion solution. It is a clear, slightly viscous liquid, almost colourless, yellow, amber or green in appearance.

ALBUTEIN 50 g/l; 250 ml vial
ALBUTEIN 50 g/l; 500 ml vial
ALBUTEIN 200 g/l; 50 ml vial
ALBUTEIN 250 g/l; 50 ml vial

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Grifols Italia S.p.A.
Via Torino, 15
56010 Vicopisano
Pisa - ITALY

Manufacturer:
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - SPAIN

The following information is intended exclusively for physicians or healthcare professionals:

• ALBUTEIN must be administered intravenously, either undiluted or diluted with an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). Mixing with electrolyte solutions should be performed under aseptic conditions.
• Do not dilute albumin solutions with water for injections, as this may cause haemolysis in recipients.
• Do not mix human albumin with other medicinal products, whole blood or red blood cell concentrates.
• The solution should be clear or slightly opalescent. Do not use cloudy solutions or those containing precipitates, as this may indicate protein instability or contamination. Once the vial has been opened, the contents must be infused immediately.
• Infusion must be carried out intravenously using a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set into the vial stopper, disinfect the stopper with an antiseptic solution. Once the vial has been opened, the contents must be infused immediately.
• The albumin preparation concentration, dose and infusion rate must be adjusted according to the individual patient's needs. The required dose depends on the patient's body weight, the severity of the trauma or condition, and ongoing losses of body fluids and proteins. The necessary dose should be determined based on circulating volume rather than plasma albumin levels.
• The infusion rate must be established according to the patient's clinical condition and therapeutic indication.
• During plasmapheresis, the infusion rate should be adjusted according to the removal rate. Hypervolemia may occur if the dose and infusion rate are not adapted to the patient's haemodynamic status. Immediately discontinue infusion at the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein distension), or increased arterial or venous blood pressure, or pulmonary oedema.
• If large volumes are to be administered, the product should be warmed to room or body temperature before use.
• When administering concentrated albumin, ensure adequate patient hydration. Patients must be closely monitored to avoid circulatory overload and fluid overload.
• When administering albumin, the patient's fluid and electrolyte status must be monitored, and electrolyte balance must be restored or maintained.
• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and red blood cells) must be ensured.
• Unused solutions must be disposed of in accordance with local regulations.