ALBITAL 250 G/L Инфузионный раствор

Содержание инструкции

1. ALBITAL 200 g/l Infusion solution, 250 g/l Infusion solution
   1. What is ALBITAL 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

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

Human albumin from human plasma

Read this leaflet carefully before using this medicineas 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you use 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 is ALBITAL and what it is used for

ALBITAL contains albumin (an important protein of 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 volume of circulating blood in patients who
have lost blood and/or body fluids for some reason and for whom the use of a colloid
(plasma substitute) is appropriate.

2. What you need to 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 (hypersensitivity) reaction to human albumin,
inform your doctor or nurse immediately.
Suspicion of an allergic or anaphylactic reaction requires immediate discontinuation
of the infusion. In the event of shock, standard medical treatments for shock must be implemented.

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

• decompensated heart failure (reduced cardiac output)
• hypertension (high blood pressure)
• esophageal varices (dilation of the veins of the esophagus)
• pulmonary edema (accumulation of fluid in the lungs)
• bleeding diathesis (predisposition to bleeding)
• severe anemia (deficiency of red blood cells and/or the substance that carries oxygen)
• renal and post-renal anuria (absence of urine production)

In a solution of human albumin (such as ALBITAL), it is more concentrated than plasma,
therefore when you are administered concentrated albumin, the doctor must ensure that you are
adequately hydrated and must monitor you carefully to avoid circulatory overload and
hyperhydration (i.e. an accumulation of fluid with problems with the heart and circulation).
Furthermore, human albumin solutions with a concentration of 200 – 250 g/l, such as ALBITAL, have
a relatively low content of electrolytes (salts) compared to human albumin solutions containing

• 40 – 50 g/l, therefore when you are administered albumin the doctor must check your electrolyte status (the concentration of salts in the blood) and take appropriate measures to restore or maintain electrolyte balance (see section “ The following information is intendedexclusively for doctors or healthcare professionals”).

Albumin solutions must not be diluted with water for injectable preparations because this
may cause hemolysis (rupture of red blood cells) in recipients.
If high volumes of blood need to be replenished, the doctor must check
coagulation and hematocrit (the fraction of cells in the blood). The doctor will take all necessary measures
to adequately replenish the blood components (coagulation factors, electrolytes,
platelets and red blood cells).
If the hematocrit drops below 30%, the doctor may consider it necessary to administer you concentrated red
blood cells to maintain the oxygen-carrying capacity of your blood.
If the dose and infusion rate are not adjusted according to your circulatory situation, you
may experience symptoms indicating an increase in blood volume (hypervolemia). If you notice
any of the symptoms listed below, inform your doctor immediately because the infusion must be stopped
immediately: headache, dyspnea (difficulty breathing), jugular vein congestion (swelling
of the veins running down the neck), increased blood pressure, increased venous pressure,
pulmonary edema.
For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Viral safety
When medicines are prepared from human blood or plasma, certain measures are taken to
prevent infections from passing to patients. These measures include careful selection of blood and plasma donors, to ensure that potentially infected donors are excluded, and testing
of each donation and plasma pool for the presence of any infections/viruses.

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Manufacturers of these medicines also introduce certain steps into the processing of blood and plasma that are capable of inactivating or removing viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered,
the possibility of transmission of infectious agents cannot be completely excluded. This also applies
to viruses or other types of emerging or unknown infectious agents.
No cases of viral transmission have been reported with albumin produced according to established
processes and with specifications compliant with those of the European Pharmacopoeia.
It is strongly recommended that each time you are administered a dose of ALBITAL, both the name
and the batch number of the product are recorded, in order to maintain traceability of the batch
used.
Patients with renal insufficiency
ALBITAL can be administered to patients undergoing dialysis, given that the aluminum content of the finished product
is less than 200 µg/l.

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

Other medicines and ALBITAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No specific interactions of human albumin with other medicines are known.

Incompatibilities: ALBITAL must not be mixed with other medicines, whole blood or
concentrated red blood cells (except for the diluents recommended in the section “ The information

following is intended exclusively for doctors or healthcare professionals”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
The safety of the use of ALBITAL during pregnancy has not been established by controlled clinical
studies. However, clinical experience with albumin suggests that no adverse effects on the course of pregnancy, the fetus or the newborn are expected. No animal reproduction studies have been conducted with ALBITAL. However, human albumin is a normal constituent of
human blood.
In general, particular care should be taken when performing plasma volume replacement in a pregnant patient.

Driving and operating machinery
ALBITAL does not alter or negligibly alters the ability to drive vehicles and operate machinery.

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 is equivalent to 7.85% of the maximum recommended daily intake with the diet of 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 following the doctor's instructions exactly at all times. If you have any doubts, consult your
doctor.
ALBITAL must be administered intravenously (into a vein) and must be administered by a
doctor or a qualified nurse.

Use in children
The safety and efficacy of ALBITAL in children have not been established by controlled clinical studies and
its use in the pediatric population is based solely on established medical practice. For this
reason, ALBITAL in children should only be used 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 some symptoms such as headache, dyspnea
(difficulty breathing), congestion of the jugular veins (i.e. swelling of the veins in the neck which may
indicate cardiovascular overload), increased blood pressure, increased central venous pressure and pulmonary edema (accumulation of fluid in the lungs). As soon as you notice any of these
symptoms, immediately inform your doctor because they must stop the infusion immediately and must
carefully check your hemodynamic parameters. Furthermore, depending on the severity of the clinical
situation, urine production must be increased and heart function improved.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

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

If any of the following side effects occur, contact your doctor immediately or go to the nearest
hospital:
The following side effects may occur generally after treatment with solutions based on
human albumin:

Other side effects:

• redness;
• urticaria;
• fever;
• nausea.

These mild reactions may occur rarely and usually disappear quickly with
slowing of the infusion rate or with interruption of the infusion itself.

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Very rarely, serious reactions such as shock may occur. In these cases the infusion must be
stopped and appropriate treatment must be initiated.
Adverse reactions reported following the administration of UMAN ALBUMIN during the post-marketing
use of the medicine are described below:
Frequency Not Known (cannot be estimated from the available data)
Urticaria
Pruritus
Dyspnea
Hypotension
Erythema
Chills
Pyrexia
Tremor
For information on viral safety see section “2. What you need to know before you use
ALBITAL”.

Additional side effects in children
Although specific data are not available for the paediatric population, the few published data relating
to efficacy and safety studies have not shown significant differences between adults and children with
the same condition, provided that particular attention is paid to avoiding
overdosage.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national system at 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 ALBITAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and label after
“Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Keep the vial in the outer packaging to protect it from light.
Do not freeze.
The storage conditions must be strictly followed.
Do not use this medicine if you notice that the solution is cloudy or contains deposits. The presence of cloudiness
and 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 in the drain 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 ingredient is human albumin

The other components, per 1 liter 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 a solution for infusion. It appears as a slightly viscous, clear liquid; almost
colorless, with a yellow, amber or green coloration.
ALBITAL 200 g/l: vial of 50 ml
ALBITAL 250 g/l: vial of 50 ml + infusion set.

Marketing authorization holder and manufacturer
Marketing authorization 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:
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The following information is intended exclusively for doctors or healthcare professionals:
The concentration of the albumin preparation, the dosage and the infusion rate must be
established according to the individual needs of the patient.
The required dose depends on the patient's weight, the severity of trauma or illness, continuous
losses of body fluids and proteins. The necessary dose must be determined based on the measurement
of the adequacy of circulating volume and not based on plasma albumin levels.
If human albumin is to be administered, hemodynamic 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
• hematocrit/hemoglobin.

ALBITAL can be administered to premature infants and patients undergoing dialysis given that the aluminum content of the finished product is less than 200 g/l.
Human albumin can be administered directly intravenously or it can 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 hemolysis in recipients.
The infusion rate must be established according to individual clinical conditions and the therapeutic
indication.
In plasmapheresis, the infusion rate must be adjusted to the removal rate.
If large volumes are to be administered, the product must be warmed to room temperature
or body temperature before use.

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