Skip to Content

ALBUTEIN 250 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN SERUM ALBUMIN

View full screen / Print PDF » Download PDF ⇩
Transcript
RTA #87

7 1/2”

G

B A R CODE
P/N
Package Leaflet: Information for the User

Albutein® 250 g/l
Solution for infusion

8 13/16”

HUMAN ALBUMIN

G

Read all of this leaflet carefully before you start using
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.
In this leaflet:
1. What Albutein® 250 g/l is and what it is used for
2. Before you use Albutein® 250 g/l
3. How to use Albutein® 250 g/l
4. Possible side effects
5. How to store Albutein® 250 g/l
6. Further information
1. WHAT ALBUTEIN® 250 g/l IS AND WHAT IT IS USED FOR
Albutein® 250 g/l is a solution for intravenous infusion
containing proteins extracted from human plasma, which
is the liquid part of the blood. Each bottle contains a
solution of 250 g plasma protein/litre of which at least
95% is human albumin protein.
This medicinal product belongs to a group of medicines
known as plasma substitutes and plasma protein
fractions.
Albutein® 250 g/l is used to restore and maintain the
circulating blood volume where volume deficiency has
been demonstrated, and use of a plasma substitute is
appropriate. The choice of an albumin solution rather than
an artificial plasma substitute will depend on the clinical
situation of the individual patient, based on official
recommendations.
If you have any questions about the use of Albutein®
250 g/l please ask your doctor.
2. BEFORE YOU USE ALBUTEIN® 250 g/l
Do not use Albutein® 250 g/l
If you are allergic (hypersensitive) to human albumin
protein or to any of the other ingredients (see Important
information about some of the ingredients of Albutein®
250 g/l at the end of this section).
Take special care with Albutein® 250 g/l
• If you think you are suffering from an allergic
reaction with breathing difficulties, feeling weak or
any other symptoms, the infusion must be stopped
immediately.
• Tell your doctor if you think you are suffering from any
of the following conditions:
- A weak heart
- High blood pressure

- Oesophageal varices (enlarged veins in the
oesophagus)
- Pulmonary oedema (liquid accumulation in the lungs)
- Bleeding or blood clotting disorders
- Severe anaemia (absence of red blood cells)
- Problems with urine production
These conditions may rule out the use of Albutein®
250 g/l in your treatment, or cause the doctor to
modify the dosage/infusion rate to avoid complications.
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 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 Albutein® 250 g/l the name and
batch number of the product are recorded in order to
maintain a record of all batches that have been used.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
No specific interactions of human albumin with other
medicines are known.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
If you are pregnant or breast-feeding you must tell
your doctor who will decide if Albutein® 250 g/l can
be used.
Driving and using machines
No effects on the ability to drive and use of machines
have been observed.
Important information about some of the ingredients
of Albutein® 250 g/l
Patients on a controlled sodium diet should take into
consideration that this medicine contains 166.8 mg
(7.3 mmol) sodium per vial of 50 ml, and 333.5 mg
(14.5 mmol) sodium per vial of 100 ml.
This medicine contains very low levels of potassium.

RTA #87

8 13/16”

3. HOW TO USE ALBUTEIN® 250 g/l
Albutein® 250 g/l is a product intended for hospital
administration only. It will be administered as an
intravenous infusion by medical staff and must not
be self administered.
The dosage and the infusion rate of Albutein®
250 g/l you receive, as well as the frequency and
duration of your treatment, will be adjusted to your
individual requirements. This will be calculated for
you by your doctor.
If you use more Albutein® 250 g/l than you should
If you have been given more Albutein® 250 g/l than
required, your blood volume may increase. Tell your
doctor immediately.
Signs of overdose may include: headache, trouble
breathing, jugular vein congestion (enlarged veins
in the neck), high blood pressure, and pulmonary
oedema (liquid accumulation in the lungs).
If you forget to use Albutein® 250 g/l
Tell your doctor or pharmacist immediately and follow
his/her instructions.
You must not be given a double dose to make up for
a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Albutein® 250 g/l can cause side
effects, although not everybody gets them.
• Mild reactions such as flush, skin rash, fever and
nausea may occur rarely.
• Severe allergic reactions (anaphylactic shock)
may occur very rarely.
For information on viral safety, see section 2.
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 Yellow Card Scheme,
Website: https://yellowcard.mhra.gov.uk or telephone
0808 100 3352. By reporting side effects you can
help provide more information on the safety of this
medicine.
5. HOW TO STORE ALBUTEIN® 250 g/l
Keep out of the reach and sight of children.
Do not use Albutein® 250 g/l after the expiry date
which is stated on the bottle label and carton after
EXP. The expiry date refers to the last day of that
month.
Do not store above 30 ºC. Do not freeze.
Keep the bottle in the outer carton in order to protect
from light.

7 1/2”
The solution should be clear or slightly opalescent. Do
not use Albutein® 250 g/l if you notice that the solution
is cloudy or has deposits.
Once the bottle has been opened, the contents should be
used immediately.
Any unused product or waste material should be disposed
of in accordance with local requirements. Medicines
should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to protect
the environment.
6. FURTHER INFORMATION
What Albutein® 250 g/l contains
- The active substance is human albumin. One
millilitre of Albutein® 250 g/l contains 250 mg of
human plasma protein, of which at least 95% is
human albumin.
- The other ingredients are sodium chloride, sodium
caprylate, sodium N-acetyltryptophanate and water
for injections.
For further information about ingredients see also
“Important information about some of the ingredients of
Albutein® 250 g/l” at the end of section 2.
What Albutein® 250 g/l looks like and contents of the
pack
Albutein® 250 g/l is a solution for infusion. The solution
is clear and slightly viscous; it can be almost colourless,
slightly yellow, slightly amber or slightly green.
Albutein® 250 g/l is supplied in bottles containing 50 ml
and 100 ml of product. Pack size of 1 bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer
Responsible for Batch Release:
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
Distributed by: Grifols UK Ltd.
Byron House
Cambridge Business Park
Cambridge CB4 0WZ
Manufacturer: Grifols Biologicals Inc.
5555 Valley Boulevard
Los Angeles, California 90032 - USA
This leaflet was last revised in 04/2016.

P-2
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès 08150 Barcelona - SPAIN

Expand view ⇕

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.

Hide