Uman albumin 20% kedrion

1. What is UMAN ALBUMIN 20% KEDRION and what is it used for

UMAN ALBUMIN 20% KEDRION is a solution of human albumin, an essential protein in human blood.
UMAN ALBUMIN 20% KEDRION is used to supplement and maintain blood volume in cases where there is a demonstrated lack of volume and when the use of a colloid solution is indicated.

2. Important information before using UMAN ALBUMIN 20% KEDRION

When not to use UMAN ALBUMIN 20% KEDRION

• if the patient is allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with UMAN ALBUMIN 20% KEDRION, the patient should discuss it with their doctor.
In case of a history of allergic reactions to human albumin, the patient should immediately inform their doctor or nurse.
If there is a suspicion of an allergic reaction or anaphylactic reaction, the infusion should be stopped immediately. In case of shock, standard shock treatment should be applied.
Caution should be exercised when administering albumin if the occurrence of hypervolemia (increased blood volume) and its consequences or hemodilution (dilution of blood) could pose a particular risk to the patient.
The patient should inform their doctor if they have diseases such as:

• uncompensated heart failure,
• hypertension,
• esophageal varices,
• pulmonary edema,
• bleeding disorder,
• severe anemia,
• renal or non-renal anuria.

The albumin concentration in UMAN ALBUMIN 20% KEDRION is higher than in blood plasma.
Therefore, when administering a concentrated albumin solution, the patient's hydration status should be taken into account. The patient should be monitored during the infusion to prevent overload of the circulatory system and fluid overload.
Human albumin solutions with a concentration of 200-250 g/l have a relatively low electrolyte content compared to albumin solutions with a concentration of 40-50 g/l. During albumin administration, the doctor will monitor the patient's electrolyte levels and take appropriate action to restore or maintain electrolyte balance (see: Information intended exclusively for healthcare professionals).
Albumin solutions should not be diluted in water for injection due to the risk of hemolysis (red blood cell breakdown) in the patient.
In case of need to supplement a large volume, control of coagulation parameters and hematocrit (one of the blood test parameters) should be performed. The doctor will ensure adequate substitution of other blood components (coagulation factors, electrolytes, platelets, and red blood cells).
If the dose and infusion rate are not adjusted to the patient's circulatory system, fluid overload (hypervolemia) may occur. After the first clinical signs of circulatory overload, such as headache, dyspnea, jugular venous distension, or increased blood pressure, the infusion should be stopped immediately.
Viral safety
When administering drugs derived from human blood or plasma, certain procedures are used to prevent the transmission of infections. These include careful selection of donors to exclude the risk of infection and testing of each donation and plasma for viruses/infections.
Manufacturers also use inactivation and elimination procedures for viruses during the production of the medicine.
Despite these measures, when administering this type of medicine, it is not possible to completely exclude the possibility of transmitting infectious agents. This includes unknown and newly discovered viruses and other pathogens.
There are no confirmed reports of virus transmission with albumin produced in accordance with the approved process and with the specifications given in the European Pharmacopoeia.
It is recommended that when administering UMAN ALBUMIN 20% KEDRION to a patient, the name and batch number should be recorded in order to maintain information about the batches of the medicine used in the patient.

Children and adolescents

The safety and efficacy of UMAN ALBUMIN 20% KEDRION in children and adolescents have not been established in controlled clinical trials.

UMAN ALBUMIN 20% KEDRION and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
So far, no interactions between human albumin and other medicines are known.
Incompatibilities: UMAN ALBUMIN 20% KEDRION should not be mixed with other medicines, whole blood, and red blood cell concentrate (except for solutions recommended in Information intended exclusively for healthcare professionals).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The safety of UMAN ALBUMIN 20% KEDRION in pregnant women has not been established in controlled clinical trials. However, clinical experience with albumin suggests that it does not have a harmful effect on the course of pregnancy or on the fetus and newborn.
There are no sufficient data on the passage of albumin into human milk.
No fertility studies have been conducted with UMAN ALBUMIN 20% KEDRION in animals.
Human albumin is a normal component of human blood.

Driving and using machines

This medicine does not affect the ability to drive and use machines.
UMAN ALBUMIN 20% KEDRION contains sodium.
The medicine contains up to 157 mg of sodium (the main component of common salt) per 50 ml vial and 314 mg of sodium per 100 ml vial. This corresponds to 7.85% in 50 ml and 15.7% in 100 ml of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use UMAN ALBUMIN 20% KEDRION

UMAN ALBUMIN 20% KEDRION is administered intravenously by a doctor or qualified nurse.
This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Dosage and administration method - see: Information intended exclusively for healthcare professionals.

Use in children and adolescents

The safety and efficacy of UMAN ALBUMIN 20% KEDRION in children and adolescents have not been established.

Use of a higher dose of UMAN ALBUMIN 20% KEDRION than recommended

Fluid overload (hypervolemia) may occur if the dose and infusion rate are too high. After the first signs of circulatory overload (headache, dyspnea, jugular venous distension) or increased blood pressure, the infusion should be stopped immediately and the patient's hemodynamic parameters should be monitored.
In case of any further doubts about the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, UMAN ALBUMIN 20% KEDRION can cause side effects, although not everybody gets them.
If any of the following side effects occur, the patient should immediately contact their doctor or the nearest hospital:

• After administration of the human albumin solution, mild side effects such as sudden facial flushing
• urticaria,
• fever
• nausea may rarely occur. These mild reactions may occur rarely and usually disappear immediately after reducing the infusion rate or stopping the administration.

Severe reactions, such as shock, may occur very rarely after administration of the human albumin solution. In case of shock, the infusion should be stopped immediately and standard shock treatment should be applied.
After the introduction of UMAN ALBUMIN 20% KEDRION to the market, the following side effects have been observed with an unknown frequency (frequency cannot be estimated from the available data):

• urticaria
• pruritus
• dyspnea
• hypotension
• flush
• chills
• fever
• tremor

Viral safety - see section 2.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
tel: 22 492 13 01,
fax: 22 492 13 09,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store UMAN ALBUMIN 20% KEDRION

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Store in the outer packaging to protect from light.
Do not freeze.
The storage conditions should be strictly followed.
Do not use the medicine if the solution is cloudy or contains sediment. Such appearance may indicate that the protein is unstable or the solution has been contaminated.
After opening the container, the contents should be used immediately.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What UMAN ALBUMIN 20% KEDRION contains

• The active substance of the medicine is human albumin. The solution contains: human plasma proteins 200 g/l, including at least 95% human albumin.

A 50 ml vial contains 10 g of human albumin.
A 100 ml vial contains 20 g of human albumin.
The solution is hyperoncotic.

• Other ingredients are: sodium chloride 4.52 g/l, sodium caprylate 2.660 g/l (16 mmol/l), N-acetyltryptophan 3.940 g/l (16 mmol/l), water for injection to 1 l. The total sodium ion content in the medicine is 123.5 - 136.5 mmol/l.

What UMAN ALBUMIN 20% KEDRION looks like and what the pack contains

1 vial of 50 ml or 100 ml in a cardboard box.
The solution is clear, slightly opalescent, almost colorless, yellow, amber, or green.

Marketing authorization holder and manufacturer

Marketing authorization holder
Kedrion S.p.A. - Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca), Italy
Manufacturer
Kedrion S.p.A. - 55027 Bolognana Gallicano (Lucca), Italy
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
MB&S, ul. Chełmska 30/34,
00-725 Warsaw
Tel: 22 - 851 52 10

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals:
Dosage, concentration, and infusion rate should be adjusted individually to the patient's needs.
Dosage depends on the patient's body weight, severity of injury or disease, and maintenance of fluid or protein loss. The required dose should be determined based on the assessment of adequate blood volume, not on the basis of albumin concentration in plasma.
In case of need to administer human albumin, the patient's hemodynamic status should be regularly monitored, including:

• blood pressure and heart rate
• central venous pressure
• pulmonary artery pressure
• urine output
• electrolyte levels
• hematocrit/hemoglobin

Administration method

Human albumin can be administered directly by intravenous infusion or after dilution in an isotonic solution (e.g., 5% glucose solution or 0.9% sodium chloride solution).
Albumin solutions should not be diluted in water for injection due to the risk of hemolysis in the patient.
The infusion rate should be adjusted individually to the patient's condition and indications.
During plasma exchange, the infusion rate should be adjusted to the rate of plasma removal.
If larger volumes are administered, the medicine should be warmed to room temperature or body temperature before use.