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VOLUVEN 6% SOLUTION FOR INFUSION

Active substance(s): HYDROXYETHYL STARCH 130/0.4 / SODIUM CHLORIDE

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4264-7_4264-5 VOLUVEN - UK 09/02/16 08:17 Page1

The solution should be used immediately after opening, any any solution remaining after treatment
should be discarded. For single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Voluven 6 % contains
1000 ml solution for infusion contain:
Active substances:
Poly(O-2-hydroxyethyl)starch (Ph. Eur.) . . . . . . . . . . . .60 g
- Molar substitution: 0.38 – 0.45
- Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)
Sodium chloride . . . . . . . . . . . . . . .. . . . . . . . . . . . . .. . . . . . . . .. . . . . . 9 g
Electrolytes:
Na+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 mmol/l
Cl- . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 mmol/l
Theoretical osmolarity: . . . . . . . . . . . . 308 mosm/l
Titratable acidity: . . . . . . . . . . . < 1.0 mmol NaOH/l
pH: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.0 – 5.5
Other ingredients: Sodium hydroxide, hydrochloric acid, water for injections.
What Voluven 6% looks like and contents of the pack
Voluven 6% is a sterile, clear to slightly opalescent solution, colourless to slightly yellow. It is
contained in:
• flexible bags made either of polyolefine (freeflex) or plasticized PVC bag
• or in a glass bottle.
Polyolefin bag (freeflex) with overwrap:
1, 5, 10, 20, 30, 35, 40 x 250 ml
1, 5, 10, 15, 20 x 500 ml
Plasticized PVC bag with overwrap:
1, 5, 25 x 250 ml, 1, 5, 15 x 500 ml
Colourless type II glass bottle with halobutyl rubber closure and aluminium cap:
1, 10 x 250 ml; 1, 10 x 500 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire, WA7 1NT, UK.
Manufacturer:
Fresenius Kabi France
6, rue du Rempart - BP 611 - 27400 Louviers Cedex - France
This medicinal product is authorised in the Member States of the EEA under the following
names:

Austria
Belgium

Voluven (HES 130/0,4) 6 % - Infusionslösung
Voluven, 6% (60 mg/ml) oplossing voor infusie / solution pour perfusion /
Infusionslösung
Denmark
Voluven
Finland
Voluven 60 mg/ml infuusioneste, liuos
Germany
Voluven Fresenius 6% Infusionslösung
Greece
Voluven 6% Διάλυμα για έγχυση
Ireland
Voluven 6% Solution for Infusion
Iceland
Voluven 6% Innrennslislyf, lausn
Italy
Voluven Soluzione per infusione
Luxembourg
Voluven Fresenius 6%
Norway
Voluven 60 mg/ml infusjonsvæske, oppløsning
Portugal
Voluven Fresenius 6%
Sweden
Voluven, 60 mg/ml infusionsvätska, lösning
The Netherlands Voluven, 6% (60 mg/ml) oplossing voor infusie
UK
Voluven 6% Solution for Infusion
This leaflet was last revised in 02/2016.
The following information is intended for healthcare professionals only:
Use of HES should be restricted to the initial phase of volume resuscitation with a maximum
time interval of 24 h.
The maximum daily dose is 30 ml/kg for Voluven 6%.
The lowest possible effective dose should be applied. Treatment should be guided by continuous
haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic
goals have been achieved. The maximum recommended daily dose must not be exceeded.
The first 10-20 ml should be infused slowly and under careful monitoring of the patient so that any
anaphylactic/anaphylactoid reaction can be detected as early as possible.
If an anaphylactoid/anaphylactic reaction occurs the infusion should be discontinued immediately and
appropriate emergency medical treatment initiated.
The duration of treatment depends on:
• the extent of the low blood volume
• blood pressure
• the dilution of blood and its components (platelets, red blood cells etc.).
Use in children
There is only limited experience of the use of this medicine in children. Therefore, it is not
recommended to use this medicine in children.
For single use only.
To be used immediately after the bottle or bag is opened.
Any unused solution should be discarded.
Use only clear, particle-free solutions and undamaged containers.
Remove the overwrap from the Polyolefine (freeflex) bag and PVC bag prior to use.

V005 • 4264-7

PACKAGE LEAFLET: INFORMATION FOR THE USER

Voluven 6% solution for infusion
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
q This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. You can help by reporting any side effects you may get. See the end of section 4 for
how to report side effects.
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 or pharmacist.
- 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 of the side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Voluven 6% is and what it is used for
2. What you need to know before you take Voluven 6%
3. How to take Voluven 6%
4. Possible side effects
5. How to store Voluven 6%
6. Contents of the pack and other information
1. What Voluven 6% is and what it is used for
Voluven 6% is a plasma volume substitute that is used to restore the blood volume when you have
lost blood when other products called crystalloids are not considered sufficient alone.
2. What you need to know before you take Voluven 6%
Do not use Voluven 6% if you:
• are allergic to any of the active substances or any of the other ingredients of this medicine
• suffer from serious generalised infection (sepsis)
• suffer from burn injury
• have kidney impairment or receive dialysis
• suffer from bleeding in the brain (intracranial or cerebral bleeding)
• are critically ill (e.g. you need to stay in an intensive care unit)
• have too much fluid in your body and you have been told that you have a condition known as
hyperhydration
• have fluid in the lungs (pulmonary oedema)
• are dehydrated
• have been told that you have a severe increase of sodium or chloride in your blood
• have severely impaired liver function

4264-7_4264-5 VOLUVEN - UK 09/02/16 08:17 Page2

• have severe heart failure
• have severe problems with your blood clotting
• have received an organ transplant
Warnings and precautions
It is important to tell your doctor if you have:
• impairment of your liver function
• problems with your heart or circulation
• blood clotting (coagulation) disorders
• problems with your kidneys
Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you will be monitored closely to
detect early signs of an allergic reaction when you receive this medicine.
Surgery and trauma:
Your doctor will consider carefully if this medicine is suitable for you.
Your doctor will adjust the dose of Voluven 6% carefully in order to prevent fluid overload. This will
be done especially if you have problems with your lungs or with your heart or circulation. The nursing
staff will also take measures to observe your body's fluid balance, blood salt level, and kidney
function. If necessary you may receive additional salts.
In addition it will be ensured that you receive enough fluids.
Voluven 6% is contraindicated if you have kidney impairment or kidney injury requiring dialysis.
If impaired kidney function occurs during therapy:
If the doctor detects first signs of kidney impairment he/she will stop giving you this medicine. In
addition your doctor may need to monitor your kidney function for up to 90 days.
If you are given Voluven 6% repeatedly your doctor will monitor the ability of your blood to clot,
bleeding time and other functions. In case of an impairment of the ability of your blood to clot, your
doctor will stop giving you this medicine.
If you are undergoing open heart surgery and you are on a heart-lung machine to assist in pumping
your blood during the surgery, the administration of this solution is not recommended.
Children
Data are limited in children, therefore it is recommended not to use HES products in this population.
Other medicines and Voluven 6%
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. To date, Voluven 6% is not known to have any
interactions with other medicines.
Voluven 6% with food and drink
Voluven 6% is not known to have any negative effect when given at the same time as food or drink
Pregnancy and breast-feeding
There are no data from the use of the product in pregnant (except caesarean section, see below) and
breast-feeding women. Animal studies do not indicate direct or indirect harmful effects with respect
to pregnancy, embryo/foetal development, parturition or postnatal development. No evidence of
teratogenicity was seen.
There are limited clinical study data available from the use of a single dose of Voluven 6% in
pregnant women undergoing caesarean section with spinal anesthesia. No negative influence of
Voluven 6% on patient safety could be detected; a negative influence on the neonate could also not
be detected.

If you are pregnant you doctor will only give you Voluven 6% after having weighed the benefits for
you versus the potential risk to the baby.
It is unknown whether hydroxyethyl starch is excreted in human breast milk. The excretion of
hydroxyethyl starch in milk has not been studied in animals.
If you are breast-feeding your doctor will decide on whether to continue/discontinue breast-feeding
or continue/discontinue therapy with Voluven 6% taking into account the benefit of breast-feeding to
your child and the benefit of Voluven 6% therapy to you.
Driving and using machines
After receiving Voluven 6% your ability to drive a car or operate machinery will not be affected.
3. How to use Voluven 6%
Voluven 6% will be given by, or under the direct supervision of your physician, who will closely
control the amount of Voluven 6% given to you.
Mode of administration
You will receive this medicine by infusion into a vein (intravenous drip). The speed of infusion, along
with the amount of solution infused, will depend on your specific requirements, the disease for
which the product is being used, and by reference to maximum daily dose.
Dosage
Your doctor will decide on the correct dose for you to receive.
Your doctor will use the lowest possible effective dose and will not infuse Voluven 6% for
more than 24 hours.
The maximum daily dose is 30 ml/kg for Voluven 6%.
Use in children
There is only limited experience of the use of this medicine in children. Therefore it is not
recommended to use this medicine in children.
If you have received more Voluven 6% than you should
As with all volume substitutes, if you receive too much of Voluven 6% your circulatory system can
get overloaded, which can result e.g. in water retention in your lungs (lung oedema).
Your doctor will ensure that you receive the right amount of Voluven 6%. However, different people
need different doses, and if the dose does prove too much for you, your doctor may stop Voluven
6% immediately and, if necessary, administer a medicine that removes water from the body
(diuretic).
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Voluven 6% can cause side effects, although not everybody gets them.
Very common:
may affect more than 1 in 10 people
Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1,000 people
Very rare:
may affect up to 1 in 10,000 people
Not known:
frequency cannot be estimated from the available data

Blood and lymphatic system disorders:
Rare (may affect up to 1 in 1,000 people): After administration of hydroxyethyl starch, disturbances
of blood clotting beyond dilution can occur depending on the dose.
Immune system disorders:
Rare (may affect up to 1 in 1,000 people): Medicinal products containing hydroxyethyl starch may
lead to severe allergic reactions (reddening of the skin, mild influenza like symptoms, low or high
heart rate, swelling of the throat and difficult breathing, fluid in the lungs not caused by heart
problems).
Skin and subcutaneous tissue disorders:
Common (may affect up to 1 in 10 people): Itching is a known side effect of hydroxyethyl starches
when used over long periods of time and at high doses.
Investigations:
Common (may affect up to 1 in 10 people): The level of the enzyme serum amylase can rise during
administration of hydroxyethyl starch and can interfere with the diagnosis of inflammation of the
pancreas (pancreatitis). However, in this case the elevated serum amylase level must not be
considered diagnostic of pancreatitis.
Other effects are associated with the dilution of the blood, which occurs at high dosages, such as
prolonged blood clotting time.
Frequency not known (cannot be estimated from the available data)
• Kidney injury
• Liver injury
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:
For UK: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
For IE: Reports may be made by following the links to the online reporting option accessible from the
IMB homepage, or by completing the downloadable report form also accessible from the IMB
website, which may be completed manually and submitted to the IMB via freepost, to the following
address:
FREEPOST
IMB Pharmacovigilance
Earlsfort Terrace - IRL - Dublin 2
Tel: +353 1 6764971 - Fax: +353 1 6762517
Website: www.imb.ie - e-mail: imbpharmacovigilance@imb.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Voluven 6%
Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not use Voluven 6% after the expiry date (MM YYYY) which is stated on the label. The expiry
date refers to the last day of that month.
Your doctor or nurse will ensure that the solution is clear, free from particles, the container
undamaged and the overwrap is removed from the polyolefin (freeflex) bag before use.

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Voluven® 6% solution for infusion
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
 This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting any
side effects you may get. See the end of section 4 for how to report
side effects.
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 or pharmacist.
- This medicine has been prescribed for you. 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 of the side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Voluven® 6% is and what it is used for
What you need to know before you use Voluven 6%
How to use Voluven 6%
Possible side effects
How to store Voluven® 6%
Contents of the pack and other information.

1. What Voluven 6% is and what it is used for
Voluven 6% is a plasma volume substitute that is used to restore the
blood volume when you have lost blood when other products called
crystalloids are not considered sufficient alone.

068 3511/02

1

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 2

2. What you need to know before you use Voluven 6%
Do not use Voluven 6% if you:
• are allergic to any of the active substances or any of the other
ingredients of this medicine
• suffer from serious generalised infection (sepsis)
• suffer from burn injury
• have kidney impairment or receive dialysis
• suffer from bleeding in the brain (intracranial or cerebral bleeding)
• are critically ill (e.g. you need to stay in an intensive care unit)
• have too much fluid in your body and you have been told that you
have a condition known as hyperhydration
• have fluid in the lungs (pulmonary oedema)
• are dehydrated
• have been told that you have a severe increase of sodium or
chloride in your blood
• have severely impaired liver function
• have severe heart failure
• have severe problems with your blood clotting
• have received an organ transplant
Warnings and precautions
It is important to tell your doctor if you have:
• impairment of your liver function
• problems with your heart or circulation
• blood clotting (coagulation) disorders
• problems with your kidneys
Because of the risk of allergic (anaphylactic/anaphylactoid) reactions,
you will be monitored closely to detect early signs of an allergic reaction
when you receive this medicine.
Surgery and trauma:
Your doctor will consider carefully if this medicine is suitable for you.
Your doctor will adjust the dose of Voluven 6% carefully in order to
prevent fluid overload. This will be done especially if you have problems
with your lungs or with your heart or circulation. The nursing staff will
also take measures to observe your body's fluid balance, blood salt
level, and kidney function. If necessary you may receive additional salts.
In addition it will be ensured that you receive enough fluids.

2

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 3

Voluven 6% is contraindicated if you have kidney impairment or kidney
injury requiring dialysis.
If impaired kidney function occurs during therapy:
If the doctor detects first signs of kidney impairment he/she will stop
giving you this medicine. In addition your doctor may need to monitor
your kidney function for up to 90 days.
If you are given Voluven 6% repeatedly your doctor will monitor the
ability of your blood to clot, bleeding time and other functions. In case
of an impairment of the ability of your blood to clot, your doctor will stop
giving you this medicine.
If you are undergoing open heart surgery and you are on a heart-lung
machine to assist in pumping your blood during the surgery, the
administration of this solution is not recommended.
Children
Data are limited in children, therefore it is recommended not to use HES
products in this population.
Other medicines and Voluven 6%
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription. To date, Voluven 6% is not known to have any
interactions with other medicines.
Voluven 6% with food and drink
Voluven 6% is not known to have any negative effect when given at the
same time as food or drink.
Pregnancy and breast-feeding
There are no data from the use of the product in pregnant (except
caesarean section, see below) and breast-feeding women. Animal
studies do not indicate direct or indirect harmful effects with respect
to pregnancy, embryo/foetal development, parturition or postnatal
development. No evidence of teratogenicity was seen.
There are limited clinical study data available from the use of a single
dose of Voluven 6% in pregnant women undergoing caesarean section
with spinal anesthesia. No negative influence of Voluven 6% on patient
safety could be detected; a negative influence on the neonate could
also not be detected.

3

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 4

If you are pregnant your doctor will only give you Voluven 6% after
having weighed the benefits for you versus the potential risk to the
baby.
It is unknown whether hydroxyethyl starch is excreted in human breast
milk. The excretion of hydroxyethyl starch in milk has not been studied
in animals.
If you are breast-feeding your doctor will decide on whether to
continue/discontinue breast-feeding or continue/discontinue therapy
with Voluven 6% taking into account the benefit of breast-feeding to
your child and the benefit of Voluven 6% therapy to you.
Driving and using machines
After receiving Voluven 6% your ability to drive a car or operate machinery
will not be affected.
3. How to use Voluven 6%
Voluven 6% will be given by, or under the direct supervision of your
physician, who will closely control the amount of Voluven 6% given to you.
Mode of administration
You will receive this medicine by infusion into a vein (intravenous drip).
The speed of infusion, along with the amount of solution infused,
will depend on your specific requirements, the disease for which the
product is being used, and by reference to maximum daily dose.
Dosage
Your doctor will decide on the correct dose for you to receive.
Your doctor will use the lowest possible effective dose and will
not infuse Voluven 6% for more than 24 hours.
The maximum daily dose is 30 ml/kg for Voluven 6%.
Use in children
There is only limited experience of the use of this medicine in children.
Therefore it is not recommended to use this medicine in children.
If you have received more Voluven 6% than you should
As with all volume substitutes, if you receive too much of Voluven 6%
your circulatory system can get overloaded, which can result e.g. in
water retention in your lungs (lung oedema).

4

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 5

Your doctor will ensure that you receive the right amount of Voluven 6%.
However, different people need different doses, and if the dose does
prove too much for you, your doctor may stop Voluven 6% immediately
and, if necessary, administer a medicine that removes water from the
body (diuretic).
If you have any further questions on the use of this product, please ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Voluven 6% can cause side effects, although not
everybody gets them.
Very common
Common
Uncommon
Rare
Very rare
Not known:

may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
may affect up to 1 in 10,000 people
frequency cannot be estimated from the available
data

Blood and lymphatic system disorders:
Rare (may affect up to 1 in 1,000 people): After administration of
hydroxyethyl starch, disturbances of blood clotting beyond dilution can
occur depending on the dose.
Immune system disorders:
Rare (may affect up to 1 in 1,000 people): Medicinal products containing
hydroxyethyl starch may lead to severe allergic reactions (reddening of
the skin, mild influenza like symptoms, low or high heart rate, swelling
of the throat and difficult breathing, fluid in the lungs not caused by
heart problems).
Skin and subcutaneous tissue disorders:
Common (may affect up to 1 in 10 people): Itching is a known side
effect of hydroxyethyl starches when used over long periods of time and
at high doses.
Investigations:
Common (may affect up to 1 in 10 people): The level of the enzyme

5

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 6

serum amylase can rise during administration of hydroxyethyl starch
and can interfere with the diagnosis of inflammation of the pancreas
(pancreatitis). However, in this case the elevated serum amylase level
must not be considered diagnostic of pancreatitis.
Other effects are associated with the dilution of the blood, which occurs
at high dosages, such as prolonged blood clotting time.
Frequency not known (cannot be estimated from the available data)
• Kidney injury
• Liver injury
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:
For UK: via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For IE: Reports may be made by following the links to the online reporting
option accessible from the IMB homepage, or by completing the
downloadable report form also accessible from the IMB website, which
may be completed manually and submitted to the IMB via freepost, to
the following address:
FREEPOST
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Voluven 6%
Keep this medicine out of the sight and reach of children.
Do not freeze.

6

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 7

Do not use Voluven 6% after the expiry date (MM YYYY) which is
stated on the label. The expiry date refers to the last day of that month.
Your doctor or nurse will ensure that the solution is clear, free from
particles, the container undamaged and the overwrap is removed from
the polyolefin (freeflex) bag before use.
The solution should be used immediately after opening, and any solution
remaining after treatment should be discarded. For single use only.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Voluven 6 % contains
1000 ml solution for infusion contain:
Active substances:
Poly(O-2-hydroxyethyl)starch (Ph. Eur.)
- Molar substitution: 0.38 – 0.45
- Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)
Sodium chloride
Electrolytes:
+
Na
ClTheoretical osmolarity:
Titratable acidity:
pH:

60 g

9g
154 mmol/l
154 mmol/l
308 mosm/l
< 1.0 mmol NaOH/l
4.0 – 5.5

Other ingredients: Sodium hydroxide, hydrochloric acid, water for
injections.
What Voluven 6% looks like and contents of the pack
Voluven 6% is a sterile, clear to slightly opalescent solution, colourless
to slightly yellow. It is contained in:
• flexible bags made either of polyolefin (freeflex) or plasticized PVC bag
• or in a glass bottle.

7

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 8

Polyolefin bag (freeflex) with overwrap:
1, 5, 10, 20, 30, 35, 40 x 250 ml
1, 5, 10, 15, 20 x 500 ml
Plasticized PVC bag with overwrap: 1, 5, 25 x 250 ml, 1, 5, 15 x 500 ml
Colourless type II glass bottle with halobutyl rubber closure and
aluminium cap:
1, 10 x 250 ml; 1, 10 x 500 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT, UK
Manufacturers:
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Germany
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria

Voluven (HES 130/0,4) 6 % - Infusionslösung

Belgium

Voluven, 6% (60 mg/ml) oplossing voor infusie /
solution pour perfusion / Infusionslösung

Denmark

Voluven

Finland

Voluven 60 mg/ml infuusioneste, liuos

Germany

Voluven Fresenius 6% Infusionslösung

Greece

Voluven 6% ∆ιάλυµα για έγχυση

Ireland

Voluven 6% Solution for Infusion

Iceland

Voluven 6% Innrennslislyf, lausn

Italy

Voluven Soluzione per infusione

8

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 9

Luxembourg

Voluven Fresenius 6%

Norway

Voluven 60 mg/ml infusjonsvæske, oppløsning

Portugal

Voluven Fresenius 6%

Sweden

Voluven, 60 mg/ml infusionsvätska, lösning

The Netherlands Voluven, 6% (60 mg/ml) oplossing voor infusie
UK

Voluven 6% Solution for Infusion

This leaflet was last revised in 02/2016.

9

0683511_02_Voluven UK_PB 10.02.2016 09:55 Seite 10

The following information is intended for healthcare professionals only:
Use of HES should be restricted to the initial phase of volume
resuscitation with a maximum time interval of 24 h.
The maximum daily dose is 30 ml/kg for Voluven 6%.
The lowest possible effective dose should be applied. Treatment should
be guided by continuous haemodynamic monitoring so that the infusion
is stopped as soon as appropriate haemodynamic goals have been
achieved. The maximum recommended daily dose must not be
exceeded.
The first 10-20 ml should be infused slowly and under careful monitoring
of the patient so that any anaphylactic/anaphylactoid reaction can be
detected as early as possible.
If an anaphylactoid/anaphylactic reaction occurs the infusion should
be discontinued immediately and appropriate emergency medical
treatment initiated.
The duration of treatment depends on:
• the extent of the low blood volume
• blood pressure
• the dilution of blood and its components (platelets, red blood cells etc.).
Use in children
There is only limited experience of the use of this medicine in children.
Therefore, it is not recommended to use this medicine in children.
For single use only.
To be used immediately after the bottle or bag is opened.
Any unused solution should be discarded.
Use only clear, particle-free solutions and undamaged containers.
Remove the overwrap from the Polyolefine (freeflex) bag and PVC bag
prior to use.

V005

10

Electrolytes:
Na+
Cl–
Theoretical osmolarity:
Titratable acidity:
pH:

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9g
154 mmol/l
154 mmol/l
308 mosml/l
⬍ 1.0 mmol NaOH/l
4.0 – 5.5

Other ingredients:
Sodium hydroxide, Hydrochloric acid, Water for injections
What Voluven 6% looks like and contents of the pack
Voluven 6% is a sterile, clear to slightly opalescent solution, colourless to slightly yellow. It is contained in:
• flexible bags made either of polyolefin (freeflex) or plasticized PVC bag
• or in a glass bottle
Polyolefin bag (freeflex) with overwrap:
1, 5, 10, 20, 30, 35, 40 x 250 ml
1, 5, 10, 15, 20 x 500 ml
Plasticized PVC bag with overwrap:
1, 5, 25 x 250 ml, 1, 5, 15 x 500 ml
Colourless type II glass bottle with halobutyl rubber closure and aluminium cap:
1, 10 x 250 ml; 1, 10 x 500 ml

Use of HES should be restricted to the initial phase of volume resuscitation with a maximum time
interval of 24 h.
The maximum daily dose is 30 ml/kg for Voluven 6%.
The lowest possible effective dose should be applied. Treatment should be guided by continuous
haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals
have been achieved. The maximum recommended daily dose must not be exceeded.

Voluven® 6%
solution for infusion
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution

The first 10 – 20 ml should be infused slowly and under careful monitoring of the patient so that any
anaphylactic/anaphylactoid reaction can be detected as early as possible.
If an anaphylactoid/anaphylactic reaction occurs the infusion should be discontinued immediately and
appropriate emergency medical treatment initiated.
The duration of treatment depends on:
• the extent of the low blood volume
• blood pressure
• the dilution of blood and its components (platelets, red blood cells etc.).
Use in children
There is only limited experience of the use of this medicine in children. Therefore, it is not recommended to
use this medicine in children.

Not all pack sizes may be marketed.

For single use only.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire, WA7 1NT, UK

To be used immediately after the bottle or bag is opened.

Manufacturers:
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Germany

Remove the overwrap from the Polyolefine (freeflex) bag and PVC bag prior to use.

Any unused solution should be discarded.
Use only clear, particle-free solutions and undamaged containers.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. You can help by reporting any side effects you may get. See the end of section 4 for how to
report side effects.
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 or pharmacist.
– 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Voluven 6% is and what it is used for
2. What you need to know before you take Voluven 6%
3. How to take Voluven 6%
4. Possible side effects
5. How to store Voluven 6%
6. Contents of the pack and other information
1. What Voluven 6% is and what it is used for
Voluven 6% is a plasma volume substitute that is used to restore the blood volume when you have lost
blood when other products called crystalloids are not considered sufficient alone.

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria:
Voluven (HES 130/0,4) 6% – Infusionslösung
Belgium:
Voluven, 6% (60 mg/ml) oplossing voor infusie/solution pour perfusion/Infusionslösung
Denmark:
Voluven
Finland:
Voluven 60 mg/ml infuusioneste, liuos
Germany:
Voluven Fresenius 6% Infusionslösung
Greece:
Voluven 6% Διάλυµα για έγχυση
Ireland:
Voluven 6% Solution for Infusion
Iceland:
Voluven 6% Innrennslislyf, lausn
Italy:
Voluven Soluzione per infusione
Luxembourg:
Voluven Fresenius 6%
Norway:
Voluven 60 mg/ml infusjonsvæske, oppløsning
Portugal:
Voluven Fresenius 6%
Sweden:
Voluven, 60 mg/ml infusionsvätska, lösning
The Netherlands:
Voluven, 6% (60 mg/ml) oplossing voor infusie
UK:
Voluven 6% Solution for Infusion

2. What you need to know before you take Voluven 6%
Do not use Voluven 6% if you:
• are allergic to any of the active substances or any of the other ingredients of this medicine
• suffer from serious generalised infection (sepsis)
• suffer from burn injury
• have kidney impairment or receive dialysis
• suffer from bleeding in the brain (intracranial or cerebral bleeding)
• are critically ill (e.g. you need to stay in an intensive care unit)
• have too much fluid in your body and you have been told that you have a condition
known as hyperhydration
• have fluid in the lungs (pulmonary oedema)
• are dehydrated
• have been told that you have a severe increase of sodium or chloride in your blood
• have severely impaired liver function
• have severe heart failure
• have severe problems with your blood clotting
• have received an organ transplant

This leaflet was last revised in 02/2016.

5

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following information is intended for healthcare professionals only:

6

1

V005

Sodium chloride

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068 3631/ 06 UK

0683631_06_UK_Voluven_6%:0683631_06_UK_Voluven_6%

0683631_06_UK_Voluven_6%:0683631_06_UK_Voluven_6%

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Warnings and precautions
It is important to tell your doctor if you have:
• impairment of your liver function
• problems with your heart or circulation
• blood clotting (coagulation) disorders
• problems with your kidneys
Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you will be monitored closely to detect
early signs of an allergic reaction when you receive this medicine.
Surgery and trauma:
Your doctor will consider carefully if this medicine is suitable for you.
Your doctor will adjust the dose of Voluven 6% carefully in order to prevent fluid overload. This will be done
especially if you have problems with your lungs or with your heart or circulation. The nursing staff will also
take measures to observe your body's fluid balance, blood salt level, and kidney function. If necessary you
may receive additional salts.
In addition it will be ensured that you receive enough fluids.
Voluven 6% is contraindicated if you have kidney impairment or kidney injury requiring dialysis.
If impaired kidney function occurs during therapy:
If the doctor detects first signs of kidney impairment he/she will stop giving you this medicine. In addition
your doctor may need to monitor your kidney function for up to 90 days.
If you are given Voluven 6% repeatedly your doctor will monitor the ability of your blood to clot, bleeding time
and other functions. In case of an impairment of the ability of your blood to clot, your doctor will stop
giving you this medicine.
If you are undergoing open heart surgery and you are on a heart-lung machine to assist in pumping your
blood during the surgery, the administration of this solution is not recommended.
Children
Data are limited in children, therefore it is recommended not to use HES products in this population.
Other medicines and Voluven 6%
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. To date, Voluven 6% is not known to have any interactions with
other medicines.

Driving and using machines
After receiving Voluven 6% your ability to drive a car or operate machinery will not be affected.
3. How to use Voluven 6%
Voluven 6% will be given by, or under the direct supervision of your physician, who will closely control the
amount of Voluven 6% given to you.
Mode of administration
You will receive this medicine by infusion into a vein (intravenous drip). The speed of infusion, along with the
amount of solution infused, will depend on your specific requirements, the disease for which the product is
being used, and by reference to maximum daily dose.

There are limited clinical study data available from the use of a single dose of Voluven 6% in pregnant
women undergoing caesarean section with spinal anesthesia. No negative influence of Voluven 6% on
patient safety could be detected; a negative influence on the neonate could also not be detected.
If you are pregnant you doctor will only give you Voluven 6% after having weighed the benefits for you versus
the potential risk to the baby.
It is unknown whether hydroxyethyl starch is excreted in human breast milk. The excretion of hydroxyethyl
starch in milk has not been studied in animals.
If you are breast-feeding your doctor will decide on whether to continue/discontinue breast-feeding or
continue/discontinue therapy with Voluven 6% taking into account the benefit of breast-feeding to your child
and the benefit of Voluven 6% therapy to you.

2

Other effects are associated with the dilution of the blood, which occurs at high dosages, such as
prolonged blood clotting time.
Frequency not known (cannot be estimated from the available data)
• Kidney injury
• Liver injury

Dosage
Your doctor will decide on the correct dose for you to receive.
Your doctor will use the lowest possible effective dose and will not infuse Voluven 6% for more
than 24 hours.
The maximum daily dose is 30 ml/kg for Voluven 6%.

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:

Use in children
There is only limited experience of the use of this medicine in children. Therefore it is not recommended to
use this medicine in children.

For IE: Reports may be made by following the links to the online reporting option accessible from the IMB
homepage, or by completing the downloadable report form also accessible from the IMB website, which
may be completed manually and submitted to the IMB via freepost, to the following address:

If you have received more Voluven® 6% than you should
As with all volume substitutes, if you receive too much of Voluven 6% your circulatory system can get
overloaded, which can result e.g. in water retention in your lungs (lung oedema).

FREEPOST
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel.: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie.

Your doctor will ensure that you receive the right amount of Voluven 6%. However, different people
need different doses, and if the dose does prove too much for you, your doctor may stop Voluven 6%
immediately and, if necessary, administer a medicine that removes water from the body (diuretic).
If you have any further questions on the use of this product, please ask your doctor or pharmacist.

For UK: 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.
4. Possible side effects
Like all medicines, Voluven 6% can cause side effects, although not everybody gets them.

Voluven 6% with food and drink
Voluven 6% is not known to have any negative effect when given at the same time as food or drink.
Pregnancy and breast-feeding
There are no data from the use of the product in pregnant (except caesarean section, see below) and
breast-feeding women. Animal studies do not indicate direct or indirect harmful effects with respect to
pregnancy, embryo/foetal development, parturition or postnatal development. No evidence of teratogenicity
was seen.

Investigations:
Common (may affect up to 1 in 10 people): The level of the enzyme serum amylase can rise during
administration of hydroxyethyl starch and can interfere with the diagnosis of inflammation of the pancreas
(pancreatitis). However, in this case the elevated serum amylase level must not be considered diagnostic of
pancreatitis.

Very common:

may affect more than 1 in 10 people

5. How to store Voluven 6%
Keep this medicine out of the sight and reach of children.

Common:

may affect up to 1 in 10 people

Do not freeze.

Uncommon:

may affect up to 1 in 100 people

Do not use Voluven 6% after the expiry date (MM YYYY) which is stated on the label. The expiry date refers
to the last day of that month.

Rare:

may affect up to 1 in 1,000 people

Very rare:

may affect up to 1 in 10,000 people

Not known:

frequency cannot be estimated from the available data

Your doctor or nurse will ensure that the solution is clear, free from particles, the container undamaged and
the overwrap is removed from the polyolefin (freeflex) bag before use.
The solution should be used immediately after opening, and any solution remaining after treatment should
be discarded. For single use only.

Blood and lymphatic system disorders:
Rare (may affect up to 1 in 1,000 people): After administration of hydroxyethyl starch, disturbances of blood
clotting beyond dilution can occur depending on the dose.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

Immune system disorders:
Rare (may affect up to 1 in 1,000 people): Medicinal products containing hydroxyethyl starch may lead to
severe allergic reactions (reddening of the skin, mild influenza like symptoms, low or high heart rate, swelling
of the throat and difficult breathing, fluid in the lungs not caused by heart problems).

6. Contents of the pack and other information
What Voluven 6% contains
1000 ml solution for infusion contain:

Skin and subcutaneous tissue disorders:
Common (may affect up to 1 in 10 people): Itching is a known side effect of hydroxyethyl starches when
used over long periods of time and at high doses.

Active substances:
Poly(O-2-hydroxyethyl)starch (Ph. Eur.)
– Molar substitution: 0.38 – 0.45
– Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)

3

4

60 g

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.

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