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HUMAN ALBUMIN 50G/L BAXTER SOLUTION FOR INFUSION

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Package leaflet: Information for the user

HUMAN ALBUMIN 50 g/l BAXTER

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.

Falz

What is in this leaflet
1. What Human Albumin 50 g/l Baxter is and what it is used for
2. What you need to know before you use Human Albumin 50 g/l
Baxter
3. How to use Human Albumin 50 g/l Baxter
4. Possible side effects
5. How to store Human Albumin 50 g/l Baxter
6. Contents of the pack and other information

Falz

1. What Human Albumin 50 g/l Baxter is and what it is used for
Human Albumin 50 g/l Baxter 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.

Falz

2. What you need to know before you use Human Albumin 50 g/l
Baxter
Do not use Human Albumin 50 g/l Baxter:
– 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 50 g/l Baxter.
– 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.

Falz

Falz

0001852

Solution for Infusion
Human albumin

Falz

Falz

b

– 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
– 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 50 g/l Baxter 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 50 g/l Baxter
– 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 50 g/l Baxter during pregnancy or breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Human Albumin 50 g/l Baxter contains sodium
Human Albumin 50 g/l Baxter 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 50 g/l Baxter
Human Albumin 50 g/l Baxter 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,

Perforation

The following information is intended for healthcare
professionals only:

– 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

0001852_GB-IE-MT_V1.indd 1

b

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.

02.02.15 15:32

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 50 g/l Baxter than you should
If you may have got more Human Albumin 50 g/l Baxter 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.
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 national reporting system
listed below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel:
+353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Human Albumin 50 g/l Baxter
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 50 g/l Baxter if you notice the solution is
cloudy or has particles in it.
6. Contents of the pack and other information
What Human Albumin 50 g/l Baxter contains
– 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 50 g/l Baxter 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
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
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.
Baxter Healthcare Ltd
Wallingford Road, Compton, Newbury, RG20 7QW, United Kingdom
Tel: 01635 206345
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, Bulgaria, Cyprus, Czech Republic, Germany, Greece,
Ireland, Luxemburg, Malta, Poland, Slovakia, Slovenia, United
Kingdom:
Human Albumin 50 g/l Baxter
Denmark, Estonia, Finland, Iceland, Norway, Sweden:
Albumin Baxter 50 g/l
Italy: Albumina Baxter 50 g/l
Latvia: Albumin Baxter 50 g/l šķīdums infūzijām
Lithuania: Albumin Baxter 50 g/l infuzinis tirpalas
Portugal: Albumina Humana Baxter
Romania: Albumină Umană Baxter 50 g/l soluţie perfuzabilă

This leaflet was last revised in 01/2015

Perforation

– 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 50 g/l
Baxter 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.

0001852_GB-IE-MT_V1.indd 2

02.02.15 15:32

b

Erstellt mit LCR:
Created with LCR:

Labeling Design & Development
Materialnummer:
Material number:
Farben:
Colors:

0001854

451/14

Artwork-Ersteller:
Artwork creator:

pms purpleC

□ Korrektur /Correction:
□ Imprimatur/Approval:

Date: see page header

Versionsnummer:
Update version:

1

Größe:
Size:

313 x 293

pms287u

Platzhalter:
Placeholder:

Techn. Kontrolle:
Techn. control:

Techn. Spez.:
Techn. Spec.:

Textkontrolle:
Text control:

TSBP18

Doku-Proof: □ Ja/Yes □ Nein/No

b
0001854

Package leaflet: Information for the user

HUMAN ALBUMIN 50 g/l BAXTER
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 50 g/l Baxter is and what it is used for
2. What you need to know before you use Human Albumin 50 g/l Baxter
3. How to use Human Albumin 50 g/l Baxter
4. Possible side effects
5. How to store Human Albumin 50 g/l Baxter
6. Contents of the pack and other information
1. What Human Albumin 50 g/l Baxter is and what it is used for
Human Albumin 50 g/l Baxter 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 50 g/l Baxter
Do not use Human Albumin 50 g/l Baxter:
– 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 50 g/l Baxter.
– 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
– 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
50 g/l Baxter 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 50 g/l Baxter
– Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

0001854_GB-IE-MT_V1.indd 1

02.02.15 15:37

– 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 50 g/l Baxter during pregnancy
or breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Human Albumin 50 g/l Baxter contains sodium
Human Albumin 50 g/l Baxter 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 50 g/l Baxter
Human Albumin 50 g/l Baxter 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 50 g/l Baxter than you should
If you may have got more Human Albumin 50 g/l Baxter 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.
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 national reporting system listed below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Human Albumin 50 g/l Baxter
Keep this medicine out of the sight and reach of children.

0001854_GB-IE-MT_V1.indd 2

02.02.15 15:37

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 50 g/l Baxter if you notice the solution is cloudy or has
particles in it.
6. Contents of the pack and other information
What Human Albumin 50 g/l Baxter contains
– 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 50 g/l Baxter 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
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
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.
Baxter Healthcare Ltd
Wallingford Road
Compton
Newbury
RG20 7QW
United Kingdom
Tel: 01635 206345
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, Bulgaria, Cyprus, Czech Republic, Germany, Greece, Ireland,
Luxemburg, Malta, Poland, Slovakia, Slovenia, United Kingdom:
Human Albumin 50 g/l Baxter
Denmark, Estonia, Finland, Iceland, Norway, Sweden:
Albumin Baxter 50 g/l
Italy: Albumina Baxter 50 g/l
Latvia: Albumin Baxter 50 g/l šķīdums infūzijām
Lithuania: Albumin Baxter 50 g/l infuzinis tirpalas
Portugal: Albumina Humana Baxter
Romania: Albumină Umană Baxter 50 g/l soluţie perfuzabilă
This leaflet was last revised in 01/2015

0001854_GB-IE-MT_V1.indd 3

02.02.15 15:37

Perforation

0001854_GB-IE-MT_V1.indd 4

02.02.15 15:37

b

The following information is intended for healthcare professionals
only:
– 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 50 g/l Baxter
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.

0001854_GB-IE-MT_V1.indd 5

02.02.15 15:37

Perforation

0001854_GB-IE-MT_V1.indd 6

02.02.15 15:37

+ Expand Transcript

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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