PROSPECTO:INFORMATION FOR THE USER
Alburex 50 g/l, solution for infusion
Human albumin
Read this prospectus carefully before starting to use this medication, because
it contains important information for you.
-Keep this prospectus, asperhaps you will need to read it again.
-If you have any doubts, consult your doctor, pharmacist or nurse.
- This medication has been prescribed only to you and should not be given to other people,
although they may have the same symptoms of illness, as it may harm them.
-If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospectus.
1. What isAlburex 50 g/land for what it is used
2. What you need to know before starting to useAlburex 50 g/l
3. How touse Alburex 50 g/l
4. Possible adverse effects
5. Storage ofAlburex 50 g/l
6. Contents of the package and additional information
What isAlburex 50 g/l
Alburex 50 g/l is a plasma substitute.
How Alburex 50 g/l works
The albumin stabilizes the circulating blood volume.Transports hormones, enzymes,
medicines and toxins.The albumin inAlburex 50 g/l is a protein isolated from human plasma. The albumin present in Alburex 50 g/l functions exactly as if it were your own protein.
What is Alburex 50 g/l used for
Alburex 50 g/l is indicated for the restoration and maintenance of circulating blood volume.
It is normally used in intensive care situations, when your
circulating blood volume has decreased dangerously.This can occur, for example:
The decision to use Alburex 50 g/l should be made by your doctor. Thiswill depend on your clinical situation.
Please read this section carefully. The following information should be taken into account by you and your doctor before Alburex is administered.
DO NOT use Alburex 50 g/l
If you are allergic to human albumin or any of the other components of this
medication (listed in section 6).
Please inform your doctor or pharmacist before treatment if this is the case.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Alburex 50 g/l.
Your doctor or healthcare professional will take special care if abnormal blood volume increase (hypervolemia) or blood dilution (hemodilution) may be dangerous for you.Examples of these situations are:
descompensated),
Consult your doctor or healthcare professional before treatment if you experience any of the
mentioned.
Allergic reactions (hypersensitivity reactions) may occur that can be severe and cause shock(see section 4).
Consult your doctor or healthcare professional immediately if you notice such reactions
during Alburex infusion. Your doctor will interrupt your administration completely and
begin appropriate treatment.
If the dose and infusion rate have not been adjusted to your situation, circulatory may
produce an abnormal increase in blood volume (hypervolemia). This may lead to heart and circulatory system overload (cardiovascular overload). The first
signs of this overload are headache and difficulty breathing or jugular vein distension.
Consult your doctor or healthcare professional immediately if you experience these
symptoms. Your doctor will interrupt treatment and monitor your circulation if necessary.
Information on safety in relation to infections
When manufacturing medicines from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients,including:
The analysis of each individual donation and plasma mixtures to search for signs of viruses and infections.
Despite these measures, when administering medicines obtained from human blood or
plasma, it cannot be completely ruled out that infections may be transmitted.This applies to emerging or unknown viruses and other types of infections. There are no reports
of demonstrated viral infections with albumin manufactured in accordance with the requirements
of the European Pharmacopoeia and in accordance with established processes.
It is strongly recommended that each time Alburex 50 g/l is administered, the name and batch number of the product be recorded to maintain a record of the batches used.
Interaction of Alburex 50 g/l with other medications
No specific interactions of Alburex 50 g/l with other medications are known.
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
Experiences have shown that no adverse effects should be expected on pregnancy or on the fetus or neonate.
Driving and operating machinery
No effects of Alburex 50 g/l on the ability to drive vehicles or operate machinery have been observed.
Alburex 50 g/l contains sodium
Patients with low-sodium diets should note that this medication contains approximately 3.2 mg of sodium per ml of solution (140 mmol/l). Your doctor will take this into account in the treatment of patients with low-sodium diets.
medication should be warmed to room temperature or body temperature before
administration.
amount and infusion rate depend on your individual needs.
blood flow values such as:
These values are monitored to determine the correct dose and infusion rate.
Do not mix Alburex 50 g/l with other medications or blood-derived products.
Do not mix Alburex 50 g/l with other medications or blood-derived products.
If you use more Alburex 50 g/l than you should
In case of overdose, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.
Alburex 50 g/l is only administered under medical supervision.Therefore, it is highly unlikely that you will be administered an overdose.You may experience an abnormal increase in blood volume (hypervolemia) if the dose and infusion rate are too high,which could lead to heart and circulatory system overload (cardiovascular overload).
The first symptoms of such an overload are::
If you notice these symptoms, please inform your doctor or healthcare professional immediately.
Additionally, your doctor or healthcare professional may detect symptoms such as:
In all these cases, your doctor or healthcare professional will stop the infusion and monitor your circulation if necessary.
If you have any other questions about the use of thismedication, ask your doctor, pharmacistor nurse.
Like all medicines, Alburex 50 g/l may cause side effects, although not everyone will experience them.
These side effects may occur even if you have already received Alburex 50 g/l and tolerated it well.
The general experience with human albumin solutions shows that the following side effects can be observed.
The following side effects may occur.
Allergic reactions (hypersensitivity reactions) that very rarely (affect less than 1 in 10,000 people) can be severe and cause anaphylaxis.
Symptoms of an allergic reaction may include one, some, or all of the following:
Difficulty breathing, such as wheezing, chest tightness, difficulty breathing, or coughing.
Headache, stomach pain, nausea, vomiting, or diarrhea.
If you notice these reactions during the infusion of Alburex 50 g/l, please inform your doctor or healthcare professional immediately.
In this case, your doctor or healthcare professional will suspend the infusion and initiate the appropriate treatment.
The following mild side effects may occur rarely (affect less than 1 in 1,000 people):
They usually disappear quickly as the infusion rate is reduced or the infusion is stopped.
The same side effects have been observed in Albúmina Humana Behring 5% since it has been on the market. However, the exact frequency of these side effects is unknown.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
The expiration date is the last day of the month indicated.
Do not use Alburex 50 g/l if you notice that the solution is cloudy or contains particles.
Do not throw the medications down the drain or in the trash. Ask your pharmacist where to dispose of the medications that you no longer use. In this way, you will help protect the environment.
Composition of Alburex 50 g/l
Alburex 50 g/l is a solution that contains 50 g/l of total protein, of which at least 96% is human albumin.
Theother components are:N-acetyltryptophanate of sodium, caprylate of sodium, sodium chloride, and water for injectable preparations. (see section 2)
Appearance of Alburex 50 g/l and contents of the vial
Alburex 50 g/l is a perfusion solution. The solution is transparent and slightly viscous.It may be almost colorless or yellow, amber, or greenish.
It can be obtained in the following sizes (1 vial per package):
Not all presentations may be marketed.
Holder of the marketing authorization and responsible for manufacturing
CSL Behring GmbH
Emil-von-Behringstrasse 76
D-35041 Marburg
Germany
For more information about this medication, please contact the local representative of the marketing authorization holder:
CSL Behring, S.A.
c/ Tarragona 157, 18th floor
08014 Barcelona
Spain
This medication is authorized in the member states of the European Economic Area under the following denominations:
Germany, Austria: Alburex 5, 50 g/l, Infusionslösung
Belgium, Luxembourg, Netherlands: Alburex 5, 50 g/l, Oplossing voor infusie, Solution pour perfusion, Infusionslösung
Bulgaria:????????5, 50 g/l,?????????????????
Cyprus: Alburex 5, 50 g/l,Δι?λυμαγια?γχυση
Denmark: Human Albumin CSL Behring 5%
Slovakia:Alburex5, 50g/l,infuzníroztok/infúznyroztok
Slovenia: Alburex 50 g/l raztopina za infundiranje
Spain: Alburex50 g/l, solución para perfusión
Finland, Norway, Sweden:Alburex 50 g/l, infuusioneste, liuos / infusjonsvæske, oppløsning/ Eingöngu til notkunar í bláæð/ Infusionsvätska, lösning
France: Alburex 50 g/l, solution pour perfusion
Hungary: Alburex 50g/l oldatos infúzió
Italy: Alburex 5%, 50 g/l, soluzione per infusione
Poland: Alburex 5, 50g/l, roztwór do infuzji
Portugal: Alburex 5, 50 g/l, solução para perfusão
United Kingdom, Ireland: Alburex 5, 50 g/l, solution for infusion
Romania:Alburex50g/l,solutieperfuzabila
Last revision date of this leaflet:October 2023.
For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)
http://w ww.aemps.gob.es
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.