Albital

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALBITAL 200 g/l Infusion Solution, 250 g/l Infusion Solution

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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
  1. What ALBITAL is and what it is used for
  2. What you need to know before using ALBITAL
  3. How to use ALBITAL
  4. Possible side effects
  5. How to store ALBITAL
  6. Contents of the pack and other information

1. What ALBITAL is and what it is used for

ALBITAL contains albumin (an important protein found in human blood) and belongs to a class
of medicines called "Blood substitutes and plasma protein fractions". It is prepared from
human blood collected from blood donors.
This medicine is used to restore and maintain the circulating blood volume in patients who
have lost blood and/or body fluids for any reason and for whom the use of a colloid (plasma substitute) is appropriate.

2. What you should know before using ALBITAL

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ALBITAL
If you have previously experienced symptoms of an allergic reaction (hypersensitivity) to human albumin,
inform your doctor or nurse immediately.
Suspected allergic or anaphylactic reactions require immediate discontinuation
of the infusion. In case of shock, standard medical treatments for shock must be initiated.
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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 (high blood pressure)
• esophageal varices (dilated veins in the esophagus)
• pulmonary edema (fluid accumulation in the lungs)
• hemorrhagic diathesis (tendency to bleed)
• severe anemia (deficiency in red blood cells and/or the oxygen-carrying substance)
• renal and post-renal anuria (absence of urine production)

Human albumin solution (such as ALBITAL) is more concentrated than plasma;
therefore, when concentrated albumin is administered to you, your doctor must ensure that you are
adequately hydrated and must monitor you closely to avoid circulatory overload and
overhydration (i.e. fluid accumulation causing heart and circulation problems).
Furthermore, human albumin solutions with a concentration of 200–250 g/l, such as ALBITAL, have
a relatively low electrolyte (salt) content compared to human albumin solutions containing
40–50 g/l. Therefore, when albumin is administered to you, 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
doctors or healthcare professionals”).
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis (rupture of red blood cells) in recipients.
If large volumes of blood need to be replaced, your doctor must monitor coagulation and hematocrit (the proportion of blood cells in the blood). The doctor will take all necessary measures to adequately replace blood components (clotting factors, electrolytes, platelets and red blood cells).
If your hematocrit falls below 30%, your doctor may consider it necessary to administer concentrated red blood cells to maintain your blood’s oxygen-carrying capacity.
If the dose and infusion rate are not adjusted according to your circulatory condition, 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 immediately: headache, dyspnoea (difficulty breathing), jugular vein distension (swelling of the veins running down the neck), increased blood pressure, increased venous pressure, pulmonary edema.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Viral safety
When medicines are 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 to ensure potentially infected donors are excluded, and testing of each donation and plasma pool to detect possible infections/viruses.
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Manufacturers of these medicines also include in the processing of blood and plasma certain steps 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 ruled out. This also applies to emerging or unknown viruses or other types of infectious agents.
No cases of viral transmission have been reported with albumin produced according to well-established processes and meeting specifications conforming to the European Pharmacopoeia.
It is strongly recommended that each time a dose of ALBITAL is administered to you, both the name and batch number of the product be recorded, in order to ensure traceability of the batch used.

Patients with renal impairment
ALBITAL may be administered to patients on dialysis, as the aluminium content of the finished product is less than 200 µg/l.

Children
The safety and efficacy of ALBITAL in children have not been established in controlled clinical studies.
The use of human albumin in children is based solely on established medical practice. However, clinical experience with human albumin in children suggests that no harmful effects are expected, provided particular attention is paid to dosing in order to avoid circulatory overload.
ALBITAL may be administered to premature neonates.

Other medicines and ALBITAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No specific interactions between human albumin and other medicines are known.
Incompatibilities: ALBITAL must not be mixed with other medicines, whole blood or
red blood cell concentrate (except with the diluents recommended in the section “The following information is intended exclusively for doctors or healthcare professionals”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before using this medicine.
The safety of ALBITAL during pregnancy has not been established in controlled clinical studies. However, clinical experience with albumin suggests that no harmful effects on pregnancy, the fetus or the newborn are expected. No animal reproductive studies have been conducted with ALBITAL. However, human albumin is a normal constituent of human blood.
In general, particular caution must be exercised when performing plasma volume replacement in a pregnant patient.

Driving and using machines
ALBITAL does not affect or affects negligibly the ability to drive and use machines.

ALBITAL contains sodium
This medicine contains up to a maximum of 157 mg of sodium (the main component of table salt) in each 50 ml vial.
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This amount corresponds to 7.85% of the maximum daily dietary intake recommended for an adult.

3. How to use ALBITAL

For instructions on correct use and dosage, refer to the section " The following information is intended exclusively for doctors or healthcare professionals "
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
ALBITAL must be administered intravenously (into a vein) and must be given by a doctor or a professional nurse.
Use in children
The safety and efficacy of ALBITAL in children have not been established in controlled clinical studies, and its use in the pediatric population is based solely on established medical practice. For this reason, ALBITAL should be used in children only when absolutely necessary.
If you use more ALBITAL than you should
If the dosage and infusion rate are too high, an increase in blood volume (hypervolemia) may occur. In this case, you may experience symptoms such as headache, dyspnea (difficulty breathing), jugular vein distension (i.e., swelling of the neck veins, which may indicate cardiovascular overload), increased blood pressure, elevated central venous pressure, and pulmonary edema (fluid accumulation in the lungs). As soon as you notice any of these symptoms, inform your doctor immediately, as the infusion must be stopped promptly and your hemodynamic parameters must be closely monitored. Additionally, depending on the severity of the clinical condition, urine output should be increased and cardiac function improved.
If you have any questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience
them.
If you experience any of the following adverse reactions, contact your doctor immediately or go to the
nearest hospital:
The following adverse reactions may generally occur after treatment with human albumin-based
solutions:
Other adverse reactions:

• flushing;
• urticaria;
• fever;
• nausea.

These mild reactions may rarely occur and usually resolve quickly by slowing down or stopping the
infusion rate.
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Very rarely, severe reactions such as shock may occur. In such cases, the infusion must be stopped and
appropriate treatment initiated.
Adverse reactions reported following administration of UMAN ALBUMIN during post-marketing use of
the medicine are described below:
Frequency Not Known (based on available data, it is not possible to estimate the frequency):
Urticaria
Pruritus
Dyspnea
Hypotension
Erythema
Chills
Pyrexia
Tremor
For information on viral safety, see section “2. What you need to know before using ALBITAL”.
Additional adverse reactions in children
Although specific data in the pediatric population are limited, the few published data from efficacy and
safety studies have not shown significant differences between adults and children affected by the same
condition, provided particular attention is paid to avoid overdose.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor. You
can also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ALBITAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store below 30°C.
Keep the vial in the outer packaging to protect it from light.
Do not freeze.
Storage conditions must be strictly observed.
Do not use this medicine if you notice that the solution is cloudy or contains deposits. 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.
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Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALBITAL contains
The active substance is human albumin

The other components, per 1 litre of solution, are as follows:
ALBITAL 200 g/l
Sodium chloride 4.52 g/l
Sodium caprylate 2.660 g/l (16 mmol/l)
Acetyltryptophan 3.940 g/l (16 mmol/l)
Water for injections q.s. to 1000 ml
Total sodium concentration 123.5 – 136.5 mmol/l
ALBITAL 250 g/l
Sodium chloride 3.52 g/l
Sodium caprylate 3.325 g/l (20 mmol/l)
Acetyltryptophan 4.925 g/l (20 mmol/l)
Water for injections q.s. to 1000 ml
Total sodium concentration 123.5 – 136.5 mmol/l
Description of the appearance of ALBITAL and contents of the pack
ALBITAL is an infusion solution. It is a slightly viscous, clear liquid; almost colourless, with a yellow, amber or green tint.
ALBITAL 200 g/l: 50 ml vial
ALBITAL 250 g/l: 50 ml vial + infusion set
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Kedrion S.p.A. - Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca).
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Manufacturer
Kedrion S.p.A. - 55027 Bolognana, Gallicano (Lucca).
This leaflet was last updated on:

The following information is intended exclusively for physicians or healthcare professionals:
The concentration of the albumin preparation, dosage and rate of infusion must be determined according to the individual patient's needs.
The required dose depends on the patient's body weight, the severity of trauma or illness, and ongoing losses of body fluids and proteins. The necessary dose should be determined based on assessment of circulating volume adequacy, rather than plasma albumin levels.
If human albumin is to be administered, haemodynamic performance must be monitored regularly; this may include monitoring of:

• arterial pressure and heart rate
• central venous pressure
• pulmonary artery wedge pressure
• urine output
• electrolytes
• haematocrit/haemoglobin.

ALBITAL may be administered to premature neonates and to patients undergoing dialysis, as the aluminium content of the finished product is less than 200 μg/l.
Human albumin may be administered directly by intravenous route or may be diluted with isotonic solutions (e.g. 5% glucose or 0.9% sodium chloride).
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.
The rate of infusion must be adjusted according to the individual clinical condition and therapeutic indication.
In plasmapheresis, the infusion rate should be adjusted according to the rate of removal.
If large volumes are to be administered, the product should be warmed to room or body temperature before use.
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