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FLEXBUMIN 200 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN ALBUMIN

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Package leaflet: Information for the user

Flexbumin 200 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.
In this leaflet:
1. What Flexbumin 200 g/l is and what it is used for
2. What you need to know before you use Flexbumin 200 g/l
3. How to use Flexbumin 200 g/l
4. Possible side effects
5. How to store Flexbumin 200 g/l
6. Contents of the pack and other information
1. What Flexbumin 200 g/l is and what it is used for
Flexbumin 200 g/l is a solution of plasma protein and belongs to the pharmacotherapeutic
group of plasma substitutes and plasma protein fractions. Plasma is the fluid in which
blood cells are suspended.
This medicine is used for restoration and maintenance of circulating blood volume when
there is not enough blood volume.
2. What you need to know before you use Flexbumin 200 g/l
Do not use Flexbumin 200 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 Flexbumin 200 g/l.
– If you get headache, difficulties in breathing or feeling faint during the treatment
please tell your doctor or nurse. It can be an allergic reaction.
– If you have:
– decompensated heart failure
– high blood pressure
– oesophageal varices (swelled veins in the oesophagus)
– pulmonary oedema (fluid in the lungs)
– a tendency to spontaneous bleeding
– severe anemia (lack of red blood cells)
– decreased urine formation
inform your doctor so that he/she can take appropriate precautions.
When medicines are made from human blood or plasma, certain measures 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 Flexbumin 200 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 Flexbumin 200 g/l
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor
will decide if you can use Flexbumin 200 g/l during pregnancy or breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Flexbumin 200 g/l contains sodium
Flexbumin contains 130 – 160 mmol/l sodium. To be taken into consideration by patients
on a controlled sodium diet.
3. How to use Flexbumin 200 g/l
Flexbumin 200 g/l is a medicine for hospital use. It will therefore be administered to
you in a hospital by appropriate health care personnel. Your doctor will determine the
amount of product to be administered, the frequency of dosing and the duration of
treatment based on your specific condition.
If you use more Flexbumin 200 g/l than you should
It is highly unlikely that you will get an overdose since you receive the injection in a
hospital by trained personnel.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Very common

in more than 1 in 10 patients treated

Common

in less than 1 in 10, but more than 1 in 100 patients treated

Uncommon

in less than 1 in 100, but more than 1 in 1000 patients treated

Rare

in less than 1 in 1000, but more than 1 in 10 000 patients treated

Very rare

in less than 1 in 10 000 patients treated, including isolated cases
Very
common

Common

Uncommon

Rare

Immune system
disorders

Very rare
anaphylactic shock

Gastrointestinal
disorders

nausea
(feeling
sick)

Skin and
subcutaneous
tissue disorders

flushing,
skin rash

General
disorders and
administration
site conditions

fever

• The rare side effects disappear quickly when the infusion rate is decreased or
stopped.
• If anaphylactic shock (severe allergic reactions) occurs, the infusion should be
stopped immediately and appropriate treatment initiated.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Other side effects observed after placing Human Albumin on the market are:
Hypersensitivity/Allergic reactions, Headache, Rapid heart beat, Abnormally low blood
pressure, Breathlessness or breathing discomfort, Vomiting, Altered sense of taste,
Hives, Itchiness, Chills, Heart attack, Irregular heart beat, Accumulation of fluid in the
lung.
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 Flexbumin 200 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 bag and the carton.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the bag 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 Flexbumin 200 g/l if you notice that the solution is cloudy or has deposits.
6. Contents of the pack and other information
What Flexbumin 200 g/l contains
– The active substance is human albumin.
1 liter of solution contains 200 g of total protein, of which at least 95% is human
albumin.
– The other ingredients are sodium chloride, sodium caprylate, sodium acetyltryptophanate and water for injections.
Total amount of sodium ions: 130 –160 mmol/l
What Flexbumin 200 g/l looks like and contents of the pack
Flexbumin 200 g/l is presented as a solution for infusion in a bag. Pack sizes are
12 x 100 ml (2 boxes of 6 or 12 single units), 24 x 50 ml (2 boxes of 12 or 24 single
units), 1 x 100 ml (single unit) and 1 x 50 ml (single unit).
The solution is clear and slightly viscous, almost colourless, yellow, amber or green.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Tel No.: 01635 206345
Fax No.: 01635 206071
Email: surecall@baxter.com
Manufacturer
Baxter AG
Industriestraße 67
A-1221 Vienna
Austria
This leaflet was last approved in 07/2015

The following information is intended for medical or healthcare
professionals only:
Before and during administration of Flexbumin 200 g/l
• Albumin solutions must not be diluted with water for injections as this may cause
haemolysis in recipients.
• If large volumes are administered, the product should be warmed to room or body
temperature before use.
• For safety reasons the name and batch number of Flexbumin 200 g/l should be
recorded when administered to a patient.
• Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the
patient’s circulatory situation. At the first clinical signs of cardiovascular overload
(headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised
venous pressure and pulmonary oedema, the infusion is to be stopped immediately.
Preparation
Flexbumin 200 g/l can be directly administered by the intravenous route or it can also be
diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride).
Administration of Flexbumin 200 g/l
– Do not use solutions which are cloudy or have deposits. This may indicate that the
protein is unstable or that the solution has become contaminated.
– 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
bag, the contents should be perfused immediately.
– 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.
Shelf life
Once the container has been opened, the contents should be used immediately. Any
unused medicinal product or waste material should be disposed of in accordance with
local requirements.
Incompatibilities
This medicinal product must not be mixed with other medicinal products, whole blood
and packed red cells (except an isotonic solution e.g. 5% glucose or 0.9% sodium
chloride). 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.
Use only if the seal is intact. Discard in case of leak.

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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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