Package leaflet: Information for the patient

FORTALBIA 200 mg/ml
Infusion solution
Please read carefully all the information in this leaflet before using this medicine, because it contains important information for the patient.

Please keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Fortalbia 200 mg/ml is and what it is used for
Important information before using Fortalbia 200 mg/ml
How to use Fortalbia 200 mg/ml
Possible adverse effects
How to store Fortalbia 200 mg/ml
Contents of the pack and other information

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

Fortalbia 200 mg/ml contains human albumin. Albumin is a protein found in blood, produced by the liver.
Fortalbia 200 mg/ml is used to restore and maintain blood volume in patients whose circulating blood volume has decreased, when the treating physician considers replacement therapy appropriate.

2. Information before using Fortalbia 200 mg/ml

When not to use Fortalbia 200 mg/ml

if the patient is allergic (hypersensitive) to the active substance (albumin) or to any of the other components of this medicine (listed in section 6).

When to exercise special caution with Fortalbia 200 mg/ml
The doctor should exercise special caution if the patient has any of the following conditions:

severe heart disease (decompensated heart failure),
elevated blood pressure,
esophageal varices,
breathing difficulties due to pulmonary edema,
severe bleeding (hemorrhagic disorders),
a disease affecting the number of red blood cells (severe anemia),
inability to pass urine (anuria).

In such cases, the doctor should regularly monitor the patient to ensure proper hydration.
Risk of allergic reactions
The doctor should inform the patient about warning signs associated with an allergic reaction (see section 4. Possible side effects). If any of these symptoms occur, treatment must be stopped immediately and the doctor notified so that appropriate therapy can be initiated depending on the type and severity of the reaction.
Medical examinations
The doctor should order blood tests to ensure that treatment is proceeding correctly. He or she should monitor hydration status and various blood components (coagulation factors, electrolytes, platelets, and red blood cells).
Fortalbia 200 mg/ml and other medicines
No interactions between Fortalbia 200 mg/ml and other medicinal products have been reported to date.
You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and effects on fertility
Albumin is a normal component of blood. No studies have been conducted to establish the safety of Fortalbia 200 mg/ml in pregnant or breastfeeding women. However, clinical experience with albumin suggests that the product does not have harmful effects on pregnancy, fetal or neonatal development.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
No influence on the ability to drive or operate machinery has been observed.
Important information about certain components 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 patients on a low-sodium diet.
Information on precautions related to the origin of Fortalbia 200 mg/ml
Fortalbia 200 mg/ml is manufactured from human plasma (the liquid portion of blood).
For medicines prepared from human blood or plasma, certain measures are taken to prevent transmission of infections to patients.
These measures include:

careful selection of blood and plasma donors through medical interviews to ensure donors at risk of transmitting infection are excluded,
testing of each donation and plasma pool for signs of viral infections.

The manufacturing process also includes steps designed to eliminate or inactivate viruses.
However, despite these measures, when administering medicines derived from human blood or plasma, it cannot be completely ruled out that transmission of infection may occur. This also applies to unknown viruses or newly emerging viruses, as well as to other types of infections.
To date, there have been no reported cases of viral infection transmission following administration of albumin preparations manufactured in accordance with the requirements of the European Pharmacopoeia and defined procedures.
In every case of receiving a dose of this medicine, it is recommended to record the product name and batch number in the patient's records to maintain traceability of the batches used.

3. How to use Fortalbia 200 mg/ml

Dosage
The appropriate dose, concentration, and rate of administration of Fortalbia 200 mg/ml are determined by the physician according to the individual patient's condition. The correct dose depends on the following factors:

the patient's height,
the patient's body weight,
the severity of the disease.

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

arterial blood pressure and pulse rate,
central venous pressure,
pulmonary arterial pressure,
urine output,
electrolyte concentrations,
blood components (hematocrit/hemoglobin concentration).

Fortalbia 200 mg/ml may be used in premature infants and dialyzed patients.
If the effect of Fortalbia 200 mg/ml appears too strong or too weak, inform your doctor or pharmacist.

Method and route of administration
Fortalbia 200 mg/ml may be administered directly intravenously or after dilution with an isotonic solution.
Infusions of Fortalbia 200 mg/ml must be performed under supervision of medical personnel.
Medical staff will ensure proper treatment course and take all necessary actions in case of hypersensitivity reactions.

Use of a higher than recommended dose of Fortalbia 200 mg/ml
If the dose administered or the rate of administration is too high, hypervolemia (increased circulating blood volume) may occur. In case of headache, breathing difficulties, distended neck veins, increased blood pressure, elevated central venous pressure, or pulmonary edema, inform the doctor immediately. These symptoms may indicate drug overdose. The physician will immediately discontinue treatment and initiate frequent monitoring of blood test results.

For any additional questions regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
General or local allergic reactions, such as:

swelling of the throat and face area (Quincke's oedema), local or generalised oedema,
burning and tingling sensation at the injection site,
redness, itching (pruritus), skin rashes affecting the entire body or limited areas (generalised urticaria, urticarial reaction),
drop in blood pressure (hypotension),
increased heart rate (tachycardia), chest tightness,
nausea, vomiting,
chills,
drowsiness, extreme fatigue (weakness),
restlessness,
headache (cephalalgia),
tingling (paraesthesiae),
wheezing (similar to asthma).

In case of allergic reactions, administration of the medicine should be discontinued.
Information on how to act in such a situation is also provided in section 2. Risk of allergic reactions.
Other adverse reactions
In rare cases, mild reactions such as facial rash, urticaria, fever, and nausea may be observed. These reactions usually resolve quickly after slowing down or stopping the infusion.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting of adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product and helps to collect more information on its safety.

5. How to store Fortalbia 200 mg/ml

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Store the vial in the original outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the vial and carton.
The expiry date refers to the last day of the stated month.
The solution should be clear or slightly opalescent, colourless, yellow, amber, or green.
Do not use this medicine if the solution appears cloudy or contains particles. This may
be a sign of protein instability or contamination of the solution.
The medicine should be used immediately after opening the vial.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Fortalbia 200 mg/ml contains
The active substance 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 of 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 contents of the pack
Fortalbia 200 mg/ml is a solution for infusion in 50 ml and 100 ml vials. The solution should be clear or slightly opalescent, colourless, yellow, amber, or green.

Marketing Authorisation Holder and Manufacturer
"BIOMED-LUBLIN" Vaccines and Sera Manufacturing Joint-Stock Company
20-029 Lublin, ul. Uniwersytecka 10
Poland
tel 81 533 82 21
fax 81 533 80 60
e-mail [email protected]

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

Indications
Fortalbia 200 mg/ml is indicated for the restoration and maintenance of circulating blood volume in conditions where hypovolaemia has been demonstrated, and where treatment with a colloid is appropriate.
The choice of albumin over a synthetic colloid should be based on the patient's clinical condition and in accordance with official recommendations.

Preparation of the medicinal product
The albumin solution must not be diluted with water for injections, as this may lead to haemolysis in the patient.

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

Method and route of administration
Infusions of Fortalbia 200 mg/ml must be administered under the supervision of medical personnel. This person will monitor whether the treatment is proceeding correctly and will take any necessary actions in case of hypersensitivity reactions.
The solution should be administered by intravenous infusion, either directly or after dilution with an isotonic solution (e.g. 50 mg/ml [5%] glucose solution or 9 mg/ml [0.9%] sodium chloride solution).
When large volumes of the solution are administered, it should be warmed to room temperature or body temperature prior to infusion.
Any unused product or waste material should be disposed of in accordance with local regulations.

Special warnings and precautions for use
If an allergic or anaphylactic reaction is suspected, the infusion must be stopped immediately. In case of shock, appropriate anti-shock measures should be initiated in accordance with current medical standards.
Patients must be closely monitored to avoid circulatory overload and fluid overload.
The patient's electrolyte levels should be monitored, and appropriate measures taken to restore or maintain electrolyte balance.