Fortalbia 200 mg/ml

Leaflet included in the packaging: patient information

FORTALBIA 200 mg/ml

Infusion solution

You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fortalbia 200 mg/ml and what is it used for
• 2. Important information before using Fortalbia 200 mg/ml
• 3. How to use Fortalbia 200 mg/ml
• 4. Possible side effects
• 5. How to store Fortalbia 200 mg/ml
• 6. Contents of the packaging and other information

1. What is Fortalbia 200 mg/ml and what is it used for

Fortalbia 200 mg/ml contains human albumin. Albumin is a protein that occurs in the blood, produced by the liver.
Fortalbia 200 mg/ml is used to restore and maintain blood volume in patients who have lost blood, when the doctor considers it necessary to start replacement therapy.

2. Important information before using Fortalbia 200 mg/ml

When not to use Fortalbia 200 mg/ml

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

When to exercise special caution when using Fortalbia 200 mg/ml

The doctor should exercise special caution if the patient has any of the following conditions:

• severe heart disease (uncompensated heart failure),
• high blood pressure,
• esophageal varices,
• breathing difficulties due to pulmonary edema,
• severe bleeding (bleeding disorders),
• diseases affecting red blood cells (severe anemia),
• inability to urinate (anuria).

In such cases, the doctor should regularly monitor the patient to ensure that the patient is properly hydrated.

Risk of allergic reactions

The doctor should inform the patient about the warning signs associated with an allergic reaction (see section 4. Possible side effects). If any of these symptoms occur, treatment should be stopped immediately and the doctor should be notified, who will start appropriate therapy depending on the type and severity of the reaction.

Medical examinations

The doctor should order blood tests to ensure that the treatment is proceeding correctly.
The doctor should monitor the level of hydration and various blood components (coagulation factors, mineral salts, platelets, and red blood cells).

Fortalbia 200 mg/ml and other medicines

No interactions have been found between Fortalbia 200 mg/ml and other medicinal products.
You should tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Albumin is a normal component of blood. No studies have been conducted to determine the safety of using Fortalbia 200 mg/ml in pregnant or breastfeeding women.
However, clinical experience with albumin suggests that the product does not have a harmful effect on the course of pregnancy, fetal development, or the newborn.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.

Driving and using machines

No effect on the ability to drive and use machines has been found.

Important information about some ingredients of Fortalbia 200 mg/ml

This medicine contains sodium. Fortalbia 200 mg/ml contains 2.8 mg of sodium per 1 ml, i.e., 280 mg of sodium in a 100 ml vial and 140 mg of sodium in a 50 ml vial. The doctor should take this into account in the case of a patient on a low-sodium diet.

Information about precautions related to the origin of Fortalbia 200 mg/ml

Fortalbia 200 mg/ml is produced from human plasma (the liquid part of the blood).
In the case of medicines prepared from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients.
These measures include:

• careful selection of blood and plasma donors through medical interviews to ensure that donors who pose a risk of transmission of infection are excluded,
• testing of each donation and plasma pool for signs of viral infections.

In the production process of the medicine, processes are also taken into account that can eliminate or inactivate viruses.
However, despite the use of these measures, it cannot be completely ruled out that the transmission of infection is possible when administering medicines produced from human blood or plasma.
This also applies to all unknown viruses or newly discovered ones, or other types of infections.
No cases of viral infection have been reported after the use of albumin preparations produced in accordance with the requirements specified in the European Pharmacopoeia and specified procedures.
In any case, when receiving a dose of the medicine, it is recommended to record the product name and batch number, to keep data on the used product batches.

3. How to use Fortalbia 200 mg/ml

Dosage
The doctor determines the correct dose of the medicine, its concentration, and the rate of administration, depending on the patient's situation.
The correct dose depends on the following factors:

• patient's growth,
• patient's body weight,
• severity of the disease.

During the administration of Fortalbia 200 mg/ml, the doctor should monitor the following parameters:

• blood pressure and heart rate,
• central venous pressure,
• pulmonary artery pressure,
• amount of urine excreted,
• mineral salt concentration,
• blood components (hematocrit/hemoglobin concentration).

Fortalbia 200 mg/ml can be used in premature infants and dialysis patients.
If you feel that the effect of Fortalbia 200 mg/ml is too strong or too weak, you should inform your doctor or pharmacist.
Method and route of administration
Fortalbia 200 mg/ml can be administered directly into a vein or after dilution with an isotonic solution.
Infusions of Fortalbia 200 mg/ml should be performed under the supervision of medical personnel.
Medical personnel will ensure the proper course of treatment and take all necessary actions in case of an allergic reaction.

Use of a higher dose of Fortalbia 200 mg/ml than recommended

In the case of too high a dose or rate of administration of the medicine, hypervolemia (increase in circulating blood volume) may occur.
If you experience headache, breathing difficulties, jugular vein distension, increased blood pressure, elevated central venous pressure, and pulmonary edema, you should immediately inform your doctor.
These symptoms may be the result of an overdose of the medicine.
The doctor will immediately stop the treatment and start frequent monitoring of blood test results.
If you have any further questions about the use of the medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Generalized or localized allergic reactions, such as:

• swelling of the throat and face area (Quincke's edema), localized or generalized edema,
• burning and tingling sensation at the injection site,
• redness, itching (pruritus), skin rashes covering the whole body or limited areas (generalized urticaria, urticarial reaction),
• decreased blood pressure (hypotension),
• increased heart rate (tachycardia), chest tightness,
• nausea, vomiting,
• chills,
• drowsiness, extreme fatigue (weakness),
• restlessness,
• headache (cephalgia),
• tingling (paresthesia),
• wheezing (similar to asthma).

If an allergic reaction occurs, the administration of the medicine should be stopped.
Information on how to behave in this situation can also be found in section 2. Risk of allergic reactions.

Other side effects

In rare cases, mild reactions such as facial flushing, urticaria, fever, and nausea may be observed.
These reactions usually disappear quickly after reducing the infusion rate or stopping it.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fortalbia 200 mg/ml

The medicine should be stored out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
The vial should be stored in the original outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the vial label and carton.
The expiry date refers to the last day of the specified month.
The solution should be clear or slightly opalescent, colorless, yellow, amber, or green.
Do not use this medicine if you notice that the solution is cloudy or contains precipitates.
This may be a sign of protein instability or solution contamination.
The medicine should be used immediately after opening the vial.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Fortalbia 200 mg/ml contains

The active substance of the medicine is albumin (200 g/l).
A 100 ml vial contains 20 g of human albumin.
A 50 ml vial contains 10 g of human albumin.
The total protein content in the solution is 200 g/l (i.e., 20%), of which at least 95% is human albumin.
The other ingredients are sodium chloride, sodium caprylate, and water for injections.

What Fortalbia 200 mg/ml looks like and what the packaging contains

Fortalbia 200 mg/ml is an infusion solution in 50 and 100 ml vials.
The solution should be clear or slightly opalescent, colorless, yellow, amber, or green.

Marketing authorization holder and manufacturer

BIOMED-LUBLIN S.A.
20-029 Lublin, Uniwersytecka 10 Street
Poland
tel 81 533 82 21
fax 81 533 80 60
e-mail biomed@biomed.lublin.pl

Date of the last update of the leaflet:

The following information is intended exclusively for medical personnel or healthcare professionals:

Indications

Fortalbia 200 mg/ml is used to restore and maintain blood volume in cases where hypovolemia has been demonstrated and the use of a colloid is justified.
The choice of albumin, rather than an artificial colloid, should be made based on the patient's clinical condition, in accordance with official recommendations.

Preparation of the medicinal product

The albumin solution should not be diluted with water for injections, as this may cause hemolysis in the patient.

Dosage

The required dose should be determined based on the blood volume to be restored, not on the basis of the albumin concentration in the plasma.

Method and route of administration

Infusions of Fortalbia 200 mg/ml should be performed under the supervision of medical personnel.
The person will check if the treatment is proceeding correctly and will take all necessary actions in case of an allergic reaction.
The solution should be administered as an infusion into a vein, either directly or after dilution with an isotonic solution (e.g., glucose solution with a concentration of 50 mg/ml, i.e., 5%, or sodium chloride solution with a concentration of 9 mg/ml, i.e., 0.9%).
In the case of administration of large volumes of the solution, it should be warmed to room temperature or body temperature before infusion.
Any unused product or waste should be disposed of in accordance with local regulations.

Special warnings and precautions for use

In the case of suspected allergic or anaphylactic reactions, the infusion should be stopped immediately.
In the case of anaphylaxis, appropriate emergency procedures should be followed, in accordance with current medical standards.
Patients should be closely monitored to prevent overloading of the circulatory system and fluid overload.
The patient's electrolyte levels should be monitored and appropriate actions should be taken to restore or maintain electrolyte balance.