PROBUMIN 200 G/L Инфузионный раствор

Содержание инструкции

1. Probumin 200 g/l, solution for infusion
   1. What is Probumin and what is it used for
   2. What you need to know before using Probumin
   3. How to use Probumin
   4. Possible side effects
   5. How to store Probumin
   6. Package contents and other information

Probumin 200 g/l, solution for infusion

Human Albumin
Read this leaflet carefully before using this medicine as 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Probumin and what is it used for

Probumin is a human albumin solution from human plasma (an important protein in human blood) and belongs to a class of medicines called “Blood substitutes and plasma protein fractions”.
Probumin is used for the replenishment and maintenance of circulating blood volume in patients who have lost blood and/or body fluids for any reason and where the use of a colloid is appropriate.
If you have any doubts about the use of Probumin, please consult your doctor or pharmacist.

2. What you need to know before using Probumin

Do not use Probumin
If you are allergic (hypersensitive) to human albumin or to any of the other components of this
medicinal product (listed in paragraph 6; also refer to the section “Important information on some
excipients of Probumin” at the end of this paragraph).

Warnings and precautions
Talk to your doctor or nurse before using Probumin.
If you have previously experienced symptoms of an allergic reaction (hypersensitivity, with difficulty
breathing, feeling of weakness or other symptoms) 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.
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
pose a particular risk to you.

• If you suffer from any of the following disorders, inform your doctor:
• Decompensated heart failure (reduced cardiac output)
• Arterial 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)

These conditions may preclude the therapeutic use of Probumin or induce the doctor to modify
the dose or infusion rate, to avoid complications.
Albumin solutions must not be diluted with water for injectable preparations because
this can cause hemolysis (rupture of red blood cells) in recipients.
If high volumes of blood need to be replenished, the doctor must check the
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).
In a human albumin solution, it is more concentrated than plasma, therefore when you
are given concentrated albumin, the doctor must ensure that you are adequately
hydrated and must monitor you carefully to avoid circulatory overload and hyperhydration
(i.e. a problem with the heart and circulation with fluid accumulation).
If the dose and infusion rate are not adjusted according to your circulatory status, 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), congestion of the jugular veins
(swelling of the veins running down the neck), increased blood pressure, increased
venous pressure, pulmonary edema.

Caution for athletes: the active substance contained in this preparation is
included in the list of prohibited substances for doping.
Viral safety
When medicines are produced from human blood or plasma, specific measures are taken
to prevent the transmission of infections to patients. These measures include:

• careful selection of blood and plasma donors, to ensure that potentially infected donors are excluded,
• testing of each donation and plasma pool for the possible presence of viruses/infections,
• inclusion of certain steps in the processing of blood or plasma, capable of inactivating or removing viruses.

Despite these measures, when medicinal products prepared from human blood or
plasma are administered, the possibility of transmission of infectious agents cannot be totally excluded. This
also applies to viruses or other types of infectious agents, emerging or unknown.
No cases of infection with viruses 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 receive a dose of Probumin, the name and
batch number of the product are recorded, in order to maintain traceability of the batch
used.

Children
The safety and efficacy of Probumin 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 to be expected,
provided that particular attention is paid to the dose to be administered, in order to avoid
circulatory overload.

Other medicines and Probumin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No specific interaction between albumin and other medicines is known.
Probumin must not be mixed with other medicinal products, whole blood, or concentrated red blood cells (except for the diluents recommended in the paragraph “The following information is intended

exclusively for doctors or healthcare professionals”).

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of Probumin use 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 to be expected.
In general, particular care should be taken when performing plasma volume replacement in a pregnant patient.
Breastfeeding
It is not known whether Probumin is excreted in breast milk. Excretion of human albumin in milk has not
been studied in animals. The decision to continue/interrupt breastfeeding or continue/interrupt therapy with Probumin must be made considering
the benefit of breastfeeding for the child and the benefit of Probumin therapy for the
woman.
Fertility
No reproductive studies have been conducted with Probumin 200 g/l. However
albumin is a normal constituent of human blood.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Probumin contains sodium
This medicine contains 166.8 mg of sodium (the main component of table salt) per 50 ml
vial and 333.5 mg per 100 ml vial. This corresponds to 8.3% and 16.7% respectively
of the recommended maximum daily intake of sodium with the diet of an adult.
This medicine contains potassium, less than 1 mmol (39 mg) per 50 ml or 100 ml vial, i.e.
essentially ‘potassium-free’.

3. How to use Probumin

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
Probumin must be administered intravenously (into a vein) by healthcare professionals (by a
doctor or a nurse).
The doctor will decide how much product will be administered to you, the infusion rate, the frequency and the
duration of treatment with Probumin. All this will be established based on your clinical condition.
For Instructions on correct Use and Dosage, refer to the section “ The following information is

intended exclusively for healthcare professionals”.

Use in children
The safety and efficacy of Probumin in children have not been established by controlled clinical studies and
its use in the pediatric population is based solely on established medical practice.
However, clinical experience with albumin suggests that no harmful effects are expected in
children.

If you use more Probumin 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, and this
may indicate cardiovascular overload), increased blood pressure, increased
central venous pressure and pulmonary edema (fluid accumulation in the lungs). As soon as you notice one of
these symptoms, immediately inform your doctor because the infusion must be stopped immediately and
your circulatory parameters must be carefully monitored. In addition, 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, ask your doctor.

If you forget to use Probumin
If you have forgotten to take Probumin, immediately inform your doctor and follow his instructions.
You should not be given a double dose to compensate for the missed dose.

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:

• Severe allergic reactions such as anaphylactic shock. In these cases the infusion must be stopped and appropriate treatment must be initiated. These reactions can occur very rarely.

Other side effects:

• skin redness
• skin rashes (urticaria)
• fever
• nausea
• chills
• hypotension (low blood pressure)
• tremor
• dyspnea (difficulty breathing)

These mild reactions can occur rarely and usually disappear quickly with a
slowing of the infusion rate or with discontinuation of the infusion itself.
For information on viral safety see section 2 “What you need to know before using
Probumin”.

Additional side effects in children and adolescents
There are no specific data to assess the possible occurrence of different adverse reactions
in this population.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store Probumin

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 packaging after “Exp.”. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C. Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
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.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Probumin contains

• The active ingredient is human albumin. One millilitre of Probumin 200 g/l contains 200 mg of human plasma proteins, consisting of at least 95% human albumin.
• The other ingredients are sodium chloride, sodium caprylate, sodium N-acetyltryptophanate and water for injections.

For further information on the ingredients, see also “Probumin contains sodium” at the end of
paragraph 2.

Description of the appearance of Probumin and contents of the pack
Probumin is a solution for infusion. It appears as a slightly viscous, clear,
almost colourless, yellow, amber or green liquid.
Probumin 200 g/l; 50 ml bottle
Probumin 200 g/l; 100 ml bottle

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Grifols Italia S.p.A.
Viale Enrico Forlanini, 23
20134 Milan - ITALY
Manufacturer:
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
______________________________________________________________________________

The following information is intended exclusively for doctors or healthcare professionals:

• Probumin must be administered intravenously, directly or diluted with an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). Mixing with electrolyte solutions should be carried out under aseptic conditions.
• Do not dilute albumin solutions with water for injections, as this may cause haemolysis in the recipient.
• Do not mix human albumin with other medicinal products, whole blood or red blood cell concentrates.
• The infusion is carried out intravenously using a sterile, pyrogen-free, single-use infusion set. Disinfect the stopper of the bottle using an antiseptic solution before inserting the infusion set into the stopper. Once the bottle has been opened, the contents must be infused immediately.
• 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 physical condition, the severity of the trauma or illness, ongoing fluid and protein losses. The necessary dose must be determined based on the assessment of the adequacy of circulating volume and not based on plasma albumin levels.
• The infusion rate must be established according to the individual clinical condition of the patient and the indication. During plasmapheresis, the infusion rate must be adjusted to the removal rate.
• Hypervolaemia may occur if the dosage and infusion rate are not adapted to the patient's circulatory status. At the first signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased arterial or venous blood pressure and pulmonary oedema, stop the infusion immediately.
• If large volumes are to be administered, the product must be brought to room or body temperature before use.
• When administering concentrated albumin, adequate hydration of the patient must be ensured. Patients should be carefully monitored to avoid circulatory overload and hyperhydration.
• When administering albumin, the patient's electrolyte status must be monitored and normal electrolyte balance must be restored or maintained.
• Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and red blood cells) must be ensured.