Albumin LFB

Package leaflet: Information for the user

ALBUMIN LFB 200 g/L solution for infusion

Human albumin
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What it is and what it is used for

ALBUMINA LFB contains human albumin. Albumin is a blood protein produced by the liver.
ALBUMINA LFB is used to restore and maintain blood volume in patients suffering from a
reduction in circulating blood volume, when the physician considers replacement therapy appropriate.

2. What you need to know before using ALBUMINA LFB

Do not use ALBUMINA LFB

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

Warnings and precautions
It is strongly recommended to record the name and batch number of ALBUMINA LFB each time you receive a dose, in order to maintain traceability of the batches used.
Before taking ALBUMINA LFB, consult your doctor, pharmacist, or nurse if you have any of the following conditions, in which an excessive amount of fluid in the body (hypervolaemia) may pose a particular risk to you. Albumin should be used with caution:

• if you have severe heart disease (decompensated heart failure),
• if you have high blood pressure,
• if you have enlarged veins in the esophagus (esophageal varices),
• if you have difficulty breathing due to fluid accumulation in the lungs (pulmonary edema),
• if you suffer from severe bleeding (haemorrhagic syndromes),
• if you have a low red blood cell count (anaemia),
• if you are no longer able to urinate (anuria).

In such cases, your doctor will monitor you regularly to ensure proper hydration.
Risk of allergic reactions
Your doctor will inform you about the warning signs of an allergic reaction (see section 4. Possible side effects). If any of these signs occur, stop treatment immediately and contact a doctor to initiate appropriate therapy depending on the type and severity of the reaction.
Clinical examinations
Your doctor will request blood tests to ensure that the treatment is proceeding properly. He/she will monitor your hydration status and various blood components (coagulation factors, electrolytes, platelets, and red blood cells).
Consult your doctor or pharmacist before using ALBUMINA LFB.
For individuals engaged in sports: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Information on safety measures taken due to the origin of ALBUMINA LFB
When medicines are manufactured from human blood or plasma, certain measures are implemented to prevent transmission of infections to patients. These include:

• Careful selection of blood and plasma donors to ensure that individuals who may carry infections are excluded.
• Testing of all donations and pooled plasma for signs of infection/viral presence.
• Inclusion of effective virus inactivation or removal steps during the manufacturing process of blood or plasma.

Despite these measures, when medicines prepared from human blood or plasma are administered, it cannot be completely ruled out that infections may be transmitted. This also applies to unknown or emerging viruses or other types of infections.
Albumin, produced according to a well-established process compliant with European Pharmacopoeia specifications, has a well-recognized viral safety profile.
Other medicines and ALBUMINA LFB
No specific interactions between products containing human albumin and other medicinal products are known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Albumin is a normal component of blood. No studies have been conducted in women to establish the safety of this medicinal product during pregnancy and breastfeeding. However, clinical experience with albumin suggests that harmful effects on the course of pregnancy, the fetus, or the newborn are unlikely.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
ALBUMINA LFB contains sodium
This medicine contains 140 mg of sodium (a key component of table salt) per 50 mL vial and 280 mg of sodium per 100 mL vial. This corresponds to 7% and 14% respectively of the maximum daily recommended dietary intake of sodium for an adult.
If you need to take ALBUMINA LFB daily for prolonged periods, especially if you have been advised to follow a low-sodium diet, consult your doctor or pharmacist.

3. How to use ALBUMINA LFB

Always use this medicine exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or
pharmacist.
Dosage
Your doctor will determine the appropriate dose, concentration, and rate of administration according to your condition. The appropriate dose depends on the following:

• height,
• weight,
• severity of the disease.

During administration of ALBUMINA LFB, your doctor will monitor the following parameters:

• arterial pressure and pulse rate;
• central venous pressure;
• pulmonary arterial pressure;
• urine output;
• electrolyte levels;
• blood components (hematocrit/hemoglobin).

This product may be used in premature neonates and in patients undergoing dialysis.
If you feel that the effect of ALBUMINA LFB is too strong or too weak, speak with your doctor or
pharmacist.
Method and route of administration
The solution must be administered intravenously, either directly or after dilution with an isotonic solution.
Infusions of ALBUMINA LFB must be performed under the supervision of a healthcare professional.
He/she will ensure that treatment proceeds properly and will take all necessary measures should an allergic reaction occur.
If you use more ALBUMINA LFB than you should
Hypervolemia (increased circulating blood volume) may occur if the dose and rate of administration are too high. If symptoms such as headache, chest tightness, distension of the jugular veins, increased arterial pressure, elevated central venous pressure, or pulmonary edema occur, inform your doctor immediately. These may be due to an excessive dose. The doctor will immediately discontinue your treatment and closely monitor your blood test results.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
More serious side effects:

• Severe reactions such as acute pulmonary edema or anaphylactic shock may occur. If severe reactions occur, the infusion must be stopped and appropriate treatment started immediately.
• Severe and potentially life-threatening allergic reaction requiring urgent medical treatment. The reaction may include extremely low blood pressure, throat swelling, difficulty breathing, and loss of consciousness (anaphylactic reaction, anaphylactic shock).

The infusion must be stopped in case of allergic reactions.
See also section 2. Risk of allergic reactions, for information on how to act in this situation.
Other side effects
Common: may affect up to 1 in 10 people

• Fluid around the lungs

Uncommon: may affect up to 1 in 100 people

• Too much fluid in the body (hypervolemia),
• Headache,
• Hives.

Not known: frequency cannot be estimated from the available data

• Feeling of sleepiness (somnolence),
• Sensation of "pins and needles" in arms and legs (paresthesia),
• Fast heartbeat (tachycardia),
• Sudden redness of the face and/or neck (flushing),
• Chest tightness,
• Difficulty breathing (dyspnea),
• Airway obstruction (bronchospasm),
• Nausea,
• Vomiting,
• Skin rash,
• Redness (erythema),
• Itching,
• Swelling and redness at the injection site (injection site reaction),
• Chills,
• Fever,
• Loss of energy (asthenia),
• General feeling of discomfort, physical weakness or malaise (malaise).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 medicine.

5. How to store ALBUMINA LFB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and packaging. The expiry date refers to the last day of that month.
Store below 25°C. Do not freeze. Keep the container (vial) in the original packaging (carton), protected from light.
Once the vial has been opened, the contents must be used immediately.
The solution should be clear, colourless, yellow, amber, or green. Do not use a solution that is cloudy or contains sediments, as this may indicate protein instability or contamination.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ALBUMINA LFB contains
The active substance is albumin: 200 g/L of solution, of which at least 95% is human albumin, i.e. 20%.
A 100 mL vial contains 20 g of human albumin.
A 50 mL vial contains 10 g of human albumin.
The other excipients are: sodium chloride, sodium caprylate, and water for injections.

Description of the appearance of ALBUMINA LFB and contents of the pack
ALBUMINA LFB is an infusion solution supplied in 50 mL and 100 mL vials (pack size: 1 unit).
The solution should be clear and colourless, yellow, amber, or green.
Please note that not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES
Tour W - 102 Terrasse Boieldieu, 19th Floor - 92800 Puteaux - FRANCE
Telephone: +33 (0)1 69 82 70 10

This medicinal product is authorized in the European Economic Area Member States under the following names:
France: VIALEBEX
Greece: ALBUMINE LFB
Italy: ALBUMINA LFB

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (https://www.aifa.gov.it/).

The following information is intended exclusively for healthcare professionals:

Indications
ALBUMINA LFB is used for the restoration and maintenance of circulating blood volume in cases of
demonstrated hypovolemia when use of a colloid is appropriate.

Preparation of the medicinal product
Albumin solutions must not be diluted with water for injection because this may cause hemolysis in the treated patient.

Dosage
The required dose must be determined based on the volume of blood to be restored and not on the plasma albumin concentration.

Method and route of administration
Infusions of ALBUMINA LFB must be administered under the supervision of a healthcare professional.
He/she will ensure that treatment proceeds regularly and will take all necessary measures should an allergic reaction occur.

The solution may be administered intravenously directly or after dilution in an isotonic solution (e.g., glucose 50 mg/mL (5%) or sodium chloride 9 mg/mL (0.9%)).
When large volumes are administered, the solution should be warmed to room or body temperature prior to infusion.

Any unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.

Special warnings and precautions for use
Suspected allergic or anaphylactic reactions require immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock must be initiated.
Patients must be closely monitored to prevent circulatory overload and fluid overload.
The patient's electrolyte status must be monitored, and appropriate measures must be taken to restore or maintain electrolyte balance.