UMAN 5% Roztwór do infuzji
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Treść ulotki
UMAN SERUM 5% Solution for Infusion
Human plasma proteins
Read this leaflet carefully before you start 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.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is UMAN SERUM and what is it used for
UMAN SERUM is a solution of human blood plasma proteins, consisting of not less than
90% human albumin and - and - thermostable globulins.
This medicine is used to restore and maintain blood volume in patients who
have lost blood and/or body fluids following shock conditions of any origin and nature, burns,
hypoproteinemic syndromes in general, edema from starvation, cirrhosis and all other indications for
plasmapheresis.
2. What you need to 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 (hypersensitivity) reaction to plasma
protein human preparations, inform your doctor or nurse immediately.
Suspicion of an allergic or anaphylactic type reaction requires immediate interruption
of the infusion. In the event of shock, standard medical treatments for
shock must be implemented.
Solutions containing thermostable plasma proteins 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 conditions, inform your doctor:
- decompensated heart failure (reduced cardiac performance)
- hypertension (high blood pressure)
- esophageal varices (dilation of the veins of the esophagus)
- pulmonary edema (accumulation of fluid in the lungs)
- hemorrhagic diathesis (predisposition to bleeding)
- severe anemia (deficiency of red blood cells and/or the substance that carries oxygen)
- renal and post-renal insufficiency
- dehydration (unless a sufficient amount of fluids is administered simultaneously).
Solutions containing thermostable plasma proteins must not be diluted with water for
injectable preparations as 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 the necessary measures
to adequately replenish blood components (coagulation factors, electrolytes, platelets and
red blood cells).
If the hematocrit falls below 30%, the 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 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), congestion of the jugular veins
(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 being transmitted 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 to detect any presence of infections and viruses. Manufacturers of these medicines also introduce some steps into the processing of blood and plasma that are capable of inactivating or removing viruses. Despite these measures, the possibility of transmission of infectious agents cannot be completely excluded when administering medicines prepared from human blood or plasma. This also applies to viruses or other types of emerging or unknown infectious agents.
It is strongly recommended that each time you are administered a dose of UMAN SERUM, both
the name and lot 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
Tell 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”).
The co-administration of UMAN SERUM with vasoconstrictors is not recommended.
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 taking this medicine.
The safety of the use of UMAN SERUM during pregnancy has not been established by controlled clinical
studies. However, clinical experience with autologous protein solutions 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 UMAN SERUM.
Driving and operating machinery
No effects on the ability to drive and operate machines 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 bottle.
This is equivalent to 46.25% of the maximum recommended daily intake with the diet
of 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 following exactly the instructions of 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 drip infusion) and with a dosage dependent on the patient's needs and at the doctor's discretion.
UMAN SERUM must be administered by a doctor or by a qualified nurse.
UMAN SERUM is ready for use. The infusion rate must be established based on the
individual clinical situation and therapeutic indications: normally, it should be 5 ml/min.
The maximum time for administration must be 3 hours. The infusion rate must not
exceed 30 ml/min during plasmapheresis.
If large volumes are to be administered, the product must be warmed to room
temperature or body temperature before use.
Use in children
The safety and efficacy of UMAN SERUM in children have not been established by 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 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 (accumulation of fluid in the lungs). As soon as you notice
one of these symptoms, immediately inform your doctor because he must immediately stop the infusion and
must carefully monitor your hemodynamic parameters. In addition, depending on the severity of the
clinical situation, urine production must be increased and heart function improved.
In case of accidental ingestion/administration of an excessive dose of UMAN SERUM, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask 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:
- severe reactions, such as shock. In these cases, the infusion must be stopped and appropriate treatment must be initiated. These reactions can occur very rarely.
Other side effects:
- redness;
- urticaria (hives);
- fever;
- nausea. 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 YOU USE UMAN SERUM”.
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 demonstrated significant differences between adults and children with the same condition; particular care should be taken to avoid overdose.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor. 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 UMAN SERUM
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 package and label after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 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 by only one
person and in a single infusion.
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. Contents of the pack and other information
What UMAN SERUM contains
The active ingredient is human plasma proteins.
| d UMAN SERUM 50 g/l | |
| Solution containing plasma proteins at | a 5% |
| consisting of human albumin at least at and thermostable α and β globulins | n a 90% |
| i one 250 ml bottle of solution l contains plasma proteins in an amount equal to | 12.5 g |
| a The solution is | isotonic |
The other ingredients, per 1 litre of solution, are as follows:
Sodium ion 150 mmol/l
Sodium caprylate 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 appears as a slightly viscous liquid,
clear; almost colorless, yellow, amber or green.
UMAN SERUM 5%: 250 ml bottle
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).
This leaflet was last revised on
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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 the trauma or illness,
and continuous fluid and protein losses. The necessary dose must be determined based on
assessment of the adequacy of circulating volume and not on plasma protein levels.
If a solution containing thermostable plasma proteins is to be administered, hemodynamic
performance should be monitored regularly. This may include monitoring of:
- arterial blood pressure and heart rate
- central venous pressure
- pulmonary artery wedge pressure
- urine output
- electrolytes
- hematocrit/hemoglobin.
Before the infusion of UMAN SERUM, blood group or
Rh factor determination is not necessary.
A solution containing thermostable plasma proteins can be administered directly by
intravenous route or can 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
the 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.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 5%
- Kod ATCB05AA02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki UMAN SERUMPostać farmaceutyczna: Infusion solution, 200 MLSubstancja czynna: other plasma protein fractionsWymaga receptyPostać farmaceutyczna: Infusion solution, 200 MLSubstancja czynna: other plasma protein fractionsProducent: KEDRION S.P.A.Wymaga receptyPostać farmaceutyczna: Infusion solution, 200 MLSubstancja czynna: other plasma protein fractionsProducent: KEDRION S.P.A.Wymaga recepty
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UMAN SERUM wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w UMAN SERUM jest other plasma protein fractions. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
UMAN SERUM jest produkowany przez KEDRION S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie UMAN SERUM jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić UMAN SERUM w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (other plasma protein fractions) to m.in. OKTAPLAS, PLASMAGRADE, PLASMASAFE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
