Human Serum

PACKAGE LEAFLET: INFORMATION FOR THE USER

UMAN SERUM 5% Solution for infusion

Human plasma proteins
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, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What UMAN SERUM is and what it is used for
  2. What you need to know before using UMAN SERUM
  3. How to use UMAN SERUM
  4. Possible side effects
  5. How to store UMAN SERUM
  6. Contents of the pack and other information

1. What UMAN SERUM is and what it is used for

UMAN SERUM is a solution of human blood plasma proteins, consisting of not less than 90% human albumin and thermostable (\alpha)- and (\beta)-globulins.
This medicinal product is used to restore and maintain circulating blood volume in patients who have lost blood and/or body fluids due to shock states of any origin and nature, burns, general hypoproteinaemic syndromes, malnutrition oedema, cirrhosis, and all other indications for plasma therapy.

2. What you should know before using UMAN SERUM

Do not use UMAN SERUM
If you are allergic (hypersensitive) to human plasma proteins or to any of the other components
of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor before using UMAN SERUM
If you have previously experienced symptoms of an allergic reaction (hypersensitivity) to preparations of
human plasma proteins, 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.
Solutions containing heat-treated plasma proteins must 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 (increased blood pressure)
• esophageal varices (dilated veins in the esophagus)
• pulmonary edema (fluid accumulation in the lungs)
• hemorrhagic diathesis (tendency to bleed)
• severe anemia (deficiency of red blood cells and/or oxygen-carrying substance)
• renal and post-renal insufficiency
• dehydration (unless an adequate amount of fluids is simultaneously administered).

Solutions containing heat-treated plasma proteins must not be diluted with water for
injections, as this may cause hemolysis (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 necessary measures
to adequately replace blood components (coagulation factors, electrolytes, platelets, and
red blood cells).
If hematocrit falls below 30%, your doctor may consider it necessary to administer 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 status, 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, dyspnea (difficulty breathing), jugular vein distension
(swelling of the veins running down the neck), increased arterial blood pressure,
increased venous pressure, pulmonary edema.
For athletes: using this medicine without therapeutic need constitutes doping and may
lead to a positive result in anti-doping tests.
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;
• testing of each donation and plasma pool to detect possible infections and viruses. In addition, manufacturers of these medicines 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.

It is strongly recommended that each time a dose of UMAN SERUM is administered to you,
both the name and the batch number of the product are recorded, in order to maintain traceability
of the batch used.
Children
The safety and efficacy of UMAN SERUM in children have not been established by controlled clinical studies.
Other medicines and UMAN SERUM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Incompatibilities: UMAN SERUM must not be mixed with other medicines, whole blood, or
concentrated red blood cells (except for the diluents recommended in the section “The
following information is intended exclusively for healthcare professionals”).
Concomitant administration of UMAN SERUM with vasoconstrictors is not recommended.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
The safety of using UMAN SERUM during pregnancy has not been established by controlled clinical studies. However, clinical experience with autologous protein solutions suggests that
no harmful effects on pregnancy, the fetus, or the newborn are expected. No animal reproduction studies have been conducted with UMAN SERUM.
Driving and use of machinery
No effects on the ability to drive vehicles or operate machinery have been observed.
UMAN SERUM contains sodium
This medicine contains up to a maximum of 925 mg of sodium (the main component
of table salt) per 250 ml vial.
This corresponds to 46.25% of the maximum daily recommended dietary intake
for an adult.

3. How to use UMAN SERUM

For instructions on correct use and dosage, refer to the section “The following information is intended exclusively for healthcare professionals”
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor. UMAN SERUM must be administered exclusively by intravenous route (into a vein and by slow infusion) and at a dosage dependent on the patient's needs and at the physician's discretion.
UMAN SERUM must be administered by a doctor or a professional nurse.
UMAN SERUM is ready for use. The infusion rate must be determined based on the individual clinical condition and therapeutic indications: normally, it should be 5 ml/min.
The maximum time for administration must not exceed 3 hours. The infusion rate must not exceed 30 ml/min during plasmapheresis.
If large volumes are to be administered, the product should be warmed to room or body temperature before use.

Use in children
The safety and efficacy of UMAN SERUM in children have not been established in controlled clinical studies.

If you use more UMAN SERUM 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 arterial pressure, increased central venous pressure, and pulmonary edema (fluid accumulation in the lungs). If you notice any of these symptoms, inform your doctor immediately, as the infusion must be stopped immediately and your hemodynamic parameters must be closely monitored. Additionally, depending on the severity of the clinical situation, urine output should be increased and cardiac function improved.
In case of accidental ingestion/overdose of UMAN SERUM, contact your doctor immediately or go to the nearest hospital.
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 everyone experiences them.
If you experience any of the following side effects, contact your doctor immediately or go to the
nearest hospital:

• severe reactions, such as shock. In such cases, the infusion must be stopped and appropriate treatment initiated. These reactions may occur very rarely.

Other side effects:

• flushing;
• urticaria;
• fever;
• nausea. These mild reactions may occur rarely and usually resolve quickly by slowing down or stopping the infusion rate.

For information on viral safety, see section “2. WHAT YOU SHOULD KNOW BEFORE USING HUMAN SERUM”.
Additional side effects in children
Although specific data in the paediatric population are not available, the limited published data from efficacy and safety studies have not shown significant differences between adults and children affected by the same condition; particular care should be taken to avoid overdose.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting 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 HUMAN SERUM

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.
Do not store above 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. The presence of 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, for one single person only, and in a single infusion.
Do not dispose of medicines via 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 UMAN SERUM contains
The active substance is human plasma proteins.

The other components, per 1 litre of solution, are the following:
Sodium ion 150 mmol/l
Octanoic acid sodium salt 5 mmol/l
Acetyltryptophan 5 mmol/l
Water for injections.
Description of the appearance of UMAN SERUM and contents of the pack
UMAN SERUM is an infusion solution. It is a slightly viscous, clear liquid; almost colourless, yellow, amber or green.
UMAN SERUM 5%: 250 ml vial
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Kedrion S.p.A. - Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca).
Manufacturer
Kedrion S.p.A. - 55027 Bolognana, Gallicano (Lucca).
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The following information is intended for healthcare professionals only

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 the assessment of circulating volume adequacy, and not according to plasma protein levels.
If a solution containing heat-treated plasma proteins 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.

Blood group or Rh factor determination is not required prior to infusion of UMAN SERUM.
A solution containing heat-treated plasma proteins may be administered directly intravenously or may be diluted with isotonic solutions (e.g., 5% glucose or 0.9% sodium chloride).
Plasma protein solutions must not be diluted with water for injections, as this may cause hemolysis in recipients.
The infusion rate should be established according to individual clinical conditions and therapeutic indication.
In plasmapheresis, the infusion rate should be adjusted according to the removal rate.
If large volumes are to be administered, the product should be warmed to room temperature or body temperature before use.