ALBUMEON 200 G/L Roztwór do infuzji
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Treść ulotki
- What is Albumeon and what is it used for
- What you need to know before you take Albumeon
- How to take Albumeon
- Possible side effects
- How to store Albumeon
- Package Contents and Other Information
- Albumeon is a solution containing 200 g/l of total protein, of which at least 96% is
Albumeon, 200 g/l, solution for infusion
Active substance: human albumin
contains important information for You.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Albumeon is and what it is used for
- 2. What you need to know before you are given Albumeon
- 3. How Albumeon is given
- 4. Possible side effects
- 5. How to store Albumeon
- 6. Contents of the pack and other information
1. What is Albumeon and what is it used for
What is Albumeon?
Albumeon is a plasma substitute.
How does Albumeon work
Albumin stabilizes circulating blood volume. It is a carrier of hormones, enzymes, medications and
toxins. The albumin protein of Albumeon comes from human blood plasma. Albumin therefore acts as if it were one of our own proteins.
What is Albumeon used for?
Albumeon is used to restore and maintain blood volume in circulation. It is normally used in intensive care settings, when blood volume has decreased drastically. This
may be due, for example:
- to severe blood loss following an injury or
- to extensive superficial burns. The decision to use Albumeon will be made by your doctor and will depend on your specific clinical condition.
2. What you need to know before you take Albumeon
Read this section carefully, as it contains information to be kept in mind by you and your doctor before administering the medicine.
Do not take Albumeon:
- if you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor or pharmacist before taking Albumeon.
What circumstances increase the risk of side effects?
Your doctor or pharmacist must pay particular attention in cases where an abnormal increase in blood volume (hypervolemia) or blood dilution (hemodilution) could represent a danger to the patient. Examples of such clinical conditions are listed below:
- heart failure requiring pharmacological therapy (decompensated heart failure)
- high blood pressure (hypertension)
- swelling of the veins of the esophagus (esophageal varices)
- abnormal accumulation of fluid in the lungs (pulmonary edema)
- predisposition to bleeding (hemorrhagic diathesis)
- severe decrease in red blood cells (severe anemia)
- severe decrease in urine excretion due to kidney failure or impaired outflow system (renal and post-renal anuria) Tell your doctor or pharmacist before treatment if at least one of these conditions applies to you.
In what cases may it be necessary to stop the infusion
- Allergic reactions (hypersensitivity reactions) may occur, in very rare cases with a severity sufficient to cause shock (see also section 4). If you notice these reactions during the infusion of Albumin, immediately inform your doctor or pharmacist, who will decide to completely stop the infusion and institute appropriate treatment.
- An abnormal increase in blood volume (hypervolemia) may occur in case of failure to adjust the dosage and infusion rate. This could lead to an overload of the heart and circulatory system (cardiocirculatory overload). The first symptoms of such overload are headache, difficulty breathing or swelling of the veins in the neck (jugular vein congestion). If you notice these symptoms, immediately inform your doctor or pharmacist, who will decide to stop the infusion and monitor your circulation as needed.
Antiviral safety
For medicines obtained from human blood or plasma, measures must be taken to prevent the transmission of infections to patients, including:
- careful selection of blood or plasma donors to ensure that subjects at risk of carrying infections are excluded;
- testing of each donation and plasma pool to detect viruses/infections;
- inclusion of procedures in the preparation of blood or plasma that can inactivate or eliminate viruses.
Despite these precautions, in the case of administration of medicines obtained from human blood or plasma, it is not possible to completely exclude the possibility of transmission of infections. This also applies to unknown or emerging viruses and other types of infections.
No viral infections have been reported with albumin produced according to the specifications of the European Pharmacopoeia applying verified processing procedures.
It is strongly recommended to record the name and batch number of the medicine on each occasion of administering a dose of Albumeon to keep track of the batches used.
Other medicines and Albumeon
No specific interactions of Albumeon with other medicines are known. Similarly, no adverse effects or interactions are expected.
Tell your doctor or pharmacist before treatment if you are taking or have recently taken or may take any other medicine.
Albumeon must not be mixed with other medicines and blood-derived products.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Albumeon during pregnancy or breastfeeding has not been specifically studied.
However, medicines containing human albumin have been used in pregnant women or during breastfeeding. Clinical experience suggests that no adverse effects are to be expected during pregnancy, or in the fetus and newborn.
Driving and operating machinery
No effects of Albumeon on the ability to drive vehicles and operate machinery have been observed.
Albumeon contains sodium
Vial 50 ml
A 50 ml vial of this medicine contains 144 mg of sodium (the main component of table salt/cooking salt). This is equivalent to 7.2% of the maximum recommended daily intake of sodium for an adult.
Vial 100 ml
A 100 ml vial of this medicine contains 287.5 mg of sodium (the main component of table salt/cooking salt). This is equivalent to 14.4% of the maximum recommended daily intake of sodium for an adult.
3. How to take Albumeon
Albumeon is administered by a doctor. Albumeon is intended exclusively for use via
intravenous injection (intravenous infusion).
The doctor will decide the dose of Albumeon to be taken. The quantity and infusion rate
depend on individual needs (see also section 2).
The doctor will regularly monitor important blood flow values, such as:
- blood pressure
- heart rate or
- diuresis. These values are monitored to establish the appropriate dose and infusion rate.
What to do in case of an overdose of Albumeon
Albumeon is usually administered exclusively under medical supervision. Overdosage
is therefore very unlikely. An abnormal increase in blood volume (hypervolemia) may
occur if the dose and infusion rate are too high. This could lead to
overload of the heart and circulatory system (cardiovascular overload).
The first symptoms of such overload are:
- headache
- difficulty breathing or
- swelling of the veins in the neck (jugular vein congestion). Inform the doctor immediately if you experience these symptoms.
The doctor may also find symptoms such as
- increased blood pressure
- increased central venous pressure or
- abnormal accumulation of fluid in the lungs (pulmonary edema). In all these cases, the doctor will stop the infusion and monitor your circulation as needed.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
These side effects may occur even if Albumeon has been taken before and has been well tolerated.
General experiencewith Human Albumin solutions has indicated that the following side effects can be observed:
Allergic reactions (hypersensitivity reactions), in very rare cases of sufficient severity to cause shock.
Symptoms of an allergic reaction may include one or more of the following manifestations:
- skin reactions, such as redness, itching, swelling, blisters, rashes or hives (itchy bumps on the skin)
- difficulty breathing, such as asthma, chest tightness, shortness of breath or cough
- swelling of the face, eyelids, lips, tongue or throat
- cold-like symptoms, such as stuffy or runny nose, sneezing, redness, itching, swelling or watery eyes
- headache, stomach pain, nausea, vomiting or diarrhea.
If you experience these symptoms, inform your doctor or pharmacist immediately, who will stop
the infusion and institute appropriate treatment.
The following mild side effects may occur rarely(occur in up to 1 in 1000 people):
- skin redness
- itchy rashes (hives)
- fever
- nausea These manifestations usually disappear quickly by decreasing or stopping the infusion.
The following serious side effects may occur very rarely(occur in up to 1 in 10000 people):
- shock
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly to
Website: 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 Albumeon
- 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 label and the packaging. The expiry date refers to the last day of that month.
- Store at a temperature below 25°C.
- Do not freeze.
- Keep the vial in the outer packaging to protect the medicine from light.
- After opening the package, the product must be used immediately.
- Do not use this medicine if you notice that the solution is cloudy or contains particles.
- 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 Albumeon contains
- The active substanceis human albumin.
Albumeon is a solution containing 200 g/l of total protein, of which at least 96% is
human albumin.
One 100 ml vial contains at least 19.2 g of human albumin.
One 50 ml vial contains at least 9.6 g of human albumin.
The other ingredientsare sodium caprylate, acetyltryptophanate, sodium chloride,
sodium hydroxide and hydrochloric acid (in small amounts, for pH adjustment) and water for
injections.
Description of the appearance of Albumeon and contents of the pack
Albumeon is a solution for infusion. The solution is transparent and slightly viscous. It may
appear almost colorless or yellow, amber or green.
Contents of the pack:
1 vial per pack (50 ml / 100 ml).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
CSL Behring S.p.A.
V.le Del Ghisallo, 20
20151 Milano
Italy
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Human Albumin “CSL Behring“20% Infusionslösung
Belgium Human Albumin CSL Behring 200 g/l solution for infusion
Human Albumin CSL Behring 200 g/l solution for perfusion
Human Albumin CSL Behring 200 g/l Infusionslösung
Bulgaria Human Albumin CSL Behring 200 g/L solution for infusion
Cyprus Albumeon
Croatia Albumeon 200 g/l otopina za infuziju
Denmark Albumin “Behring”
Estonia Human albumin CSL Behring / 200 g/l / infusioonilahus
Finland Albumin Behring
France Albumine Humaine CSL Behring 200 g/L, solution pour perfusion
Germany Albumeon
Greece Albumeon
Ireland Human Albumin CSL Behring / 200 g/l / solution for infusion
Iceland Albumin Behring / 200 g/l / solution for infusion
Latvia Human Albumin CSL Behring 200 g/l solution for infusion
Lithuania Human albumin CSL Behring 200 g/l infuzinis tirpalas
Luxembourg Human Albumin CSL Behring 200 g/l solution pour perfusion
Malta Albumeon® 20, 200 g/l, solution for infusion
Norway Albumin Behring
Netherlands Human Albumin CSL Behring 200 g/l oplossing voor infusie
Poland Human Albumin CSL Behring 200 g/l
Portugal Albumina Humana CSL Behring 200 g/l solução para perfusão
United Kingdom Albumeon 20®, 200 g/l solution for infusion
Czech Republic Human Albumin CSL Behring 200 g/l
Romania ALBUMEON 200 g/l soluție perfuzabilă
Slovakia Human Albumin CSL Behring 200 g/l
Slovenia Humani Albumin CSL Behring 200 g/l raztopina za infundiranje
Spain Albúmina Humana CSL Behring 200 g/l solución para perfusión
Hungary Human Albumin CSL Behring 200 g/l oldatos infuzio
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 200 G/L
- Kod ATCB05AA01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ALBUMEONPostać farmaceutyczna: Infusion solution, 5% (50G/L)Substancja czynna: albuminProducent: BIOTEST PHARMA GMBHWymaga receptyPostać farmaceutyczna: Infusion solution, 250 G/LSubstancja czynna: albuminProducent: KEDRION S.P.A.Wymaga receptyPostać farmaceutyczna: Infusion solution, 50 G/LSubstancja czynna: albuminProducent: BAXALTA INNOVATIONS GMBHWymaga recepty
Odpowiedniki ALBUMEON w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
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Odpowiednik ALBUMEON w Polska
Odpowiednik ALBUMEON w Ukraina
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ALBUMEON wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ALBUMEON jest albumin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ALBUMEON jest produkowany przez CSL BEHRING 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 ALBUMEON 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 ALBUMEON 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 (albumin) to m.in. ALBIOMIN, ALBITAL, ALBUMINA BAXALTA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
