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HUMAN ALBUMIN 50 G/L BAXALTA SOLUTION FOR INFUSION

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PACKAGE LEAFLET

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Package leaflet: Information for the user
HUMAN ALBUMIN BAXALTA 50 g/l
Solution for Infusion
Human albumin
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Human Albumin Baxalta 50 g/l is and what it is used for
2.
What you need to know before you use Human Albumin Baxalta 50 g/l
3.
How to use Human Albumin Baxalta 50 g/l
4.
Possible side effects
5.
How to store Human Albumin Baxalta 50 g/l
6.
Contents of the pack and other information

1. What Human Albumin Baxalta 50 g/l is and what it is used for
Human Albumin Baxalta 50 g/l contains a protein called albumin found in the liquid component of the
blood (the plasma) and belongs to the group of medical products called “plasma substitutes and plasma
protein fractions”. It is made from human blood collected from blood donors.
A vial of 250 ml contains 12.5 g of human albumin.
A vial of 500 ml contains 25 g of human albumin.
Human albumin is used to restore and maintain blood volume in patients who have lost blood or fluid
due to certain medical conditions. The choice of albumin rather than an artificial substitute and the
dose needed will depend on the clinical situation of the individual patient.

2. What you need to know before you use Human Albumin Baxalta 50 g/l
Do not use Human Albumin Baxalta 50 g/l:
if you are allergic to human albumin or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Human Albumin Baxalta 50 g/l.
if you think you have an allergic reaction during the treatment, with difficulty breathing, feeling
faint or other symptoms. If this happens, tell your doctor or nurse immediately because the
infusion will have to be stopped and medical treatment for shock may need to be implemented.
if you have:
– uncontrolled heart failure
– high blood pressure
– oesophageal varices (swollen veins in the oesophagus)
– pulmonary oedema (fluid on the lungs)
– a tendency to spontaneous bleeding
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– severe anemia (lack of red blood cells)
– no urine formation.
If you think any of these applies to you, inform your doctor so that he/she can take appropriate
precautions.
When medicines are made from human blood or plasma, certain steps are put in place to prevent
infections being passed on to patients. These include careful selection of blood and plasma donors to
make sure those at risk of carrying infections are excluded, and the testing of each donation and pools
of plasma for signs of virus/infections. Manufacturers of these products also include steps in the
processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when
medicines prepared from human blood or plasma are administered, the possibility of passing on
infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other
types of infections.
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia
specifications by established processes.
It is strongly recommended that every time you receive a dose of Human Albumin Baxalta 50 g/l the
name and batch number of the product are recorded in order to maintain a record of the batches used.
Other medicines and Human Albumin Baxalta 50 g/l
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No specific complications of taking human albumin with other medicinal products are known.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby ask
your doctor or pharmacist before taking this medicine. Your doctor will decide if you can use Human
Albumin Baxalta 50 g/l during pregnancy or breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Human Albumin Baxalta 50 g/l contains sodium
Human Albumin 50 g/l Baxalta contains 130-160 mmol/l sodium. This is to be taken into consideration
by patients on a controlled sodium diet.

3. How to use Human Albumin Baxalta 50 g/l
Human Albumin Baxalta 50 g/l is a medicine for hospital use. It will therefore be administered in a
hospital by appropriate health care personnel. Your doctor will establish the amount of product to be
administered, the frequency of dosing and the duration of treatment based on your specific condition.
He/she will monitor your condition, measuring your blood pressure and heart rate and taking blood
tests, while you are receiving Human Albumin to make sure that you are not given too much. If you
experience headache, difficulties in breathing or increased blood pressure, please tell your doctor.
If you take more Human Albumin Baxalta 50 g/l than you should
If you may have got more Human Albumin Baxalta 50 g/l than you should consult your doctor or
pharmacist immediately.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

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If any of the side effects listed below occurs, the infusion should be stopped immediately and
appropriate treatment initiated:
 anaphylactic shock (very rare: may affect up to 1 in 10 000 people)
 hypersensitivity/allergic reactions (not known: frequency cannot be estimated from the available
data)
The following side effects have also been reported:
Rare: may affect up to 1 in 1,000 people
- nausea (feeling sick)
- flushing
- skin rash
- fever
Not known: frequency cannot be estimated from the available data
- headache
- altered sense of taste
- heart attack
- irregular heartbeat
- rapid heartbeat
- abnormally low blood pressure
- accumulation of fluid in the lung
- breathlessness or breathing discomfort
- vomiting
- hives
- itchiness
- chills
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Human Albumin Baxalta 50 g/l
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. The expiry date refers to the
last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the glass vial in the outer carton in order to protect from light.
Once the package has been opened, the contents must be used immediately.
Do not use Human Albumin Baxalta 50 g/l if you notice the solution is cloudy or has particles in it.

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6. Contents of the pack and other information
What Human Albumin Baxalta 50 g/l contains
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The active substance is: human albumin.
Every 100 ml contain 5 g of total protein, of which at least 95% is human albumin.
The other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate,
water for injection.

Total amount of sodium ions: 130 –160 mmol/l
What Human Albumin Baxalta 50 g/l looks like and contents of the pack
It is a clear, slightly thick liquid; it is almost colourless, yellow, amber or green. It is a sterile solution
for intravenous infusion in 250 ml or 500 ml glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Austria
Manufacturer
Baxter AG
Industriestrasse 67
A-1221 Vienna
Austria
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
Baxalta UK Limited
Tel: + 44 1635 798777

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria: Human Albumin Baxter 50 g/l – Infusionslösung
Belgium, Germany, Luxemburg: Human Albumin 50 g/l Baxalta
Ireland, Malta, United Kingdom: Human Alumin Baxalta 50 g/l
Bulgaria, Cyprus, Czech Republic, Greece, Poland, Slovakia, Slovenia:
Human Albumin 50 g/l Baxter
Estonia: Albumin Baxter 50 g/l
Denmark, Finland, Iceland, Norway, Sweden: Albumin Baxalta 50 g/l
Italy: Albumina Baxalta 50 g/l
Latvia: Albumin Baxter 50 g/l šķīdums infūzijām
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Lithuania: Albumin Baxter 50 g/l infuzinis tirpalas
Portugal: Albumina Humana Baxalta
Romania: Albumină Umană Baxter 50 g/l soluţie perfuzabilă

This leaflet was last revised in 09/2015
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The following information is intended for healthcare professionals only:
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Human Albumin Solution 50 g/l should be administered by the intravenous route, infusing the
package contents directly.
Human Albumin Solution 50 g/l should not be diluted with water for injection, since this could
cause hemolysis in the recipient of the product.
Do not use unless seal is intact. If leaks are found, discard.
Solutions should be clear, slightly viscous, almost colourless, yellow, amber or green.. Solutions
that are turbid or showing sediments should not be used, since this could be an indication that
the protein is unstable or the solution has been contaminated. Once the package has been
opened, its contents must be used immediately.
Infusion is performed by the intravenous route using a disposable sterile and pyrogen-free
infusion set. Before inserting the infusion set in the cap, this should be disinfected with an
appropriate antiseptic. Once the infusion set is attached to the vial, the contents should be
perfused immediately. Unused solutions should be adequately discarded.
The infusion rate should be adjusted according to the individual circumstances and the
indication.
In plasma exchange the infusion rate should be adjusted to the rate of removal.
If large volumes are administered, the product should be warmed to room temperature before
use.
When concentrated albumin is administered, adequate hydration of the patient must be ensured.
Patients should be adequately monitored to prevent circulatory overload and overhydration.
When albumin is administered, the electrolyte balance of the patient should be monitored and, if
required, appropriate measures should be taken to restore or maintain it.
Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and
erythrocytes) must be ensured.
For safety reasons, the batch number of Human Albumin Baxalta 50 g/l administered should be
recorded.
Human albumin must not be mixed with other medicinal products, whole blood and packed red
cells. Further human albumin should not be mixed with protein hydrolysates (e.g. parenteral
nutrition) or solutions containing alcohol since these combinations may cause the proteins to
precipitate.
Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical
signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased
blood pressure, raised central venous pressure, and pulmonary oedema, the infusion should be
stopped immediately and the patient’s haemodynamic parameters carefully monitored.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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