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TETRASPAN 6% SOLUTION FOR INFUSION

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / MALIC ACID / POLY (0-2-HYDROXYETHYL) STARCH / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Tetraspan 6% solution for infusion
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, nurse 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 side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

If you receive more Tetraspan 6% than you should

1. What Tetraspan 6% is and what it is used for
2. What you need to know before you use Tetraspan 6%
3. How to use Tetraspan 6%
4. Possible side effects
5. How to store Tetraspan 6%
6. Contents of the pack and other information

If you have received too much Tetraspan 6%, you may suffer from fluid
overload that may affect your heart and lung function.

1. What Tetraspan 6% is and what it is used for
Tetraspan 6% is an infusion solution which is administered via a cannula
into a vein.
Tetraspan 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 use Tetraspan 6%
Do not use Tetraspan 6% if you:
• are allergic to any of the active substances or any of the other
ingredients of this medicine (listed in section 6)
• suffer from serious generalised infection (sepsis)
• suffer from burn injury
• have kidney impairment or receive dialysis
• have severe liver disease
• 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 potassium, 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 Tetraspan 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, kidney function. If necessary you may receive
additional salts.
In addition it will be ensured that you receive enough fluids.
Tetraspan 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 Tetraspan 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.
Elderly patients
Your doctor will closely monitor your condition during treatment and
may adjust your dose, as elderly patients are more likely to suffer from
problems with kidneys and heart.

Other medicines and Tetraspan 6%
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Your doctor will take special care about you if you receive/take
• a special type of antibiotics called aminoglycosides
• medicines that make you retain potassium or sodium
• medicines for the treatment of heart weakness (e.g. digitalis
preparations, digoxin).
Tetraspan 6% may increase the undesirable effects of these 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.
Pregnancy
Harmful effects on the unborn child can occur with Hydroxyethyl starch
when you have an allergic reaction to the product.
You will receive this medicine only if the doctor has considered the
potential benefits outweighing the possible risks to the unborn child,
especially when you are in the first trimester.
Breast-feeding
It is not known whether Hydroxyethyl starch passes into the breast milk.
Therefore your doctor will administer this solution to you only if he/she
thinks it is necessary and a decision will be made whether to temporarily
discontinue breast-feeding.

Driving and using machines

If this happens, your doctor will stop the infusion of Tetraspan 6%
immediately and give you any necessary treatment.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The most common side effects observed are directly related to the
therapeutic effect of starch solutions and the doses administered,
which means dilution of your blood and parts of your blood which are
responsible for blood clotting. Furthermore serious allergic reactions have
been observed.

The following side effects may be serious. If any of the
following side effects occur, the medication must be stopped
and a doctor should be consulted immediately.
Very common (may affect more than 1 in 10 people):
Decreased red blood cells and reduced blood protein concentration due
to dilution.
Common, depending on the administered dose (may affect up to 1 in
10 people):
Dilution of your blood clotting factors (parts of your blood which are
responsible for blood clotting). This may cause bleeding complications.
Rare (may affect up to 1 in 1000 people):
Allergic reactions may occur independent of dose. They can be serious and
even progress to shock. If an allergic reaction, especially an anaphylactic/
anaphylactoid reaction (including swelling of the face, tongue or throat,
difficulties to swallow, hives and breathing difficulties) occurs, your
doctor will stop the infusion of Tetraspan 6% immediately and treat you
with basic medical measures.
It is not possible to predict by tests which patients may be expected to
suffer from an allergic reaction nor to predict the course or the severity
of such an allergic reaction.
Frequency not known (cannot be estimated from the available data)
Kidney injury
Liver injury

Other side effects
Very common (may affect more than 1 in 10 people):
Infusion of Hydroxyethyl starch results in increased levels of an enzyme
called alfa-amylase in serum. This could be misinterpreted as evidence of
a pancreatic disorder.
Uncommon (may affect up to 1 in 100 people):
Itching may occur after treatment, even some weeks after the treatment
is stopped. The itching can persist for several months.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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 Tetraspan 6%
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 date of that month.
For single use only. After use, throw away the container and any unused
content.
Do not freeze.
Do not use this medicine if the solution is not clear, colourless or the
container or its closure show visible signs of damage.

6. Contents of the pack and other information
What Tetraspan 6% contains
• The active substances in 1000 ml solution are:
Hydroxyethyl starch (HES)
(Molar substitution:
(Average molecular weight:
Sodium chloride
Potassium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium acetate trihydrate
L-Malic acid

60.0 g
0.42)
130,000 Da)
6.25 g
0.30 g
0.37 g
0.20 g
3.27 g
0.67 g

• The other ingredients are:
Sodium hydroxide (for pH adjustment)
Water for injections
Electrolyte concentrations:
Sodium
Potassium
Calcium
Magnesium
Chloride
Acetate
L-Malate

140
4.0
2.5
1.0
118
24
5.0

pH:
Theoretical osmolarity:
Acidity (titration to pH 7.4):

5.6-6.4
296 mOsmol/l
<2.0 mmol/l

mmol/l
mmol/l
mmol/l
mmol/l
mmol/l
mmol/l
mmol/l

What Tetraspan 6% looks like and contents of the pack
Clear, colourless, aqueous solution.
Tetraspan 6% is available in the following packs and pack sizes.

Tetraspan 6% does not influence your ability to drive and use machines.

• Polyethylene bottle (Ecoflac plus) available in pack of:
10 x 500 ml

3. How to use Tetraspan 6%

• Plastic bag (Ecobag) with butyl rubber stopper and a polypropylene
outer bag in packs of:
20 x 250 ml
20 x 500 ml

Tetraspan 60 mg/ml is administered to you by a drip into a vein
(intravenous infusion).

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 Tetraspan 6% for more than 24 hours.
Adults
The maximum daily dose is 30 ml (1.8 g Hydroxyethyl starch) per kg body
weight.
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.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen, Germany
Telephone: +49 5661 71 0
Telefax: +49 5661 71 4567

Elderly patients and patients with a special condition
If you are an elderly patient or have problems with the lungs, heart or
circulation the dosage will be adjusted to your individual situation.

B|BRAUN
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534/NP53432/0314

This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria
Belgium
Czech Republic
Denmark
Estonia
Finland
Germany
Greece
Hungary
Ireland
Iceland
Italy
Latvia
Lithuania
Luxembourg
Norway
Poland
Portugal
Slovak Republic
Slovenia
Spain
Sweden
The Netherlands
United Kingdom

Tetraspan 6% Infusionslösung
Tetraspan 6%, 60 mg/ml oplossing voor infusie
Tetraspan 6%
Tetraspan 60 mg/ml infusionsvæske
Tetraspan 60 mg/ml infusioonilahus
Tetraspan 60 mg/ml infuusioneste, liuos
Tetraspan 6% Infusionslösung
Tetraspan, διάλυμα για έγχυση 6%
Tetraspan 60 mg/ml oldatos infúzió
EquiHes 60 mg/ml Solution for Infusion
Tetraspan 60 mg/ml innrennslislyf, lausn
Tetraspan 60 mg/ml soluzione per infusione
Tetraspan 60 mg/ml šķīdum infūzijām
Tetraspan 60 mg/ml infuzinis tirpalas
Tetraspan 6% Infusionslösung
Tetraspan 60 mg/ml infusjonsvæske, oppløsning
Tetraspan 60 mg/ml HES roztwór do infuzji
Tetraspan 60 mg/ml solução para perfusão
Tetraspan 6%
Tetraspan 60 mg/ml raztopina za infundiranje
Isohes 6% Solución para perfusión
Tetraspan 60 mg/ml infusionsvätska, lösning
Tetraspan 6% g/v, oplossing voor infusie 60g/l
Tetraspan 6% Solution for Infusion

This leaflet was last revised on 28 February 2014

The following information is intended for healthcare professionals only:

Use of Hydroxyethyl starch (HES) should be restricted to the
initial phase of volume resuscitation with a maximum time
interval of 24 h.
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.
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.

For single use only. Do not re-connect partially used containers. Use only
if the solution is clear, colourless and the container is undamaged.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not
be mixed with other medicinal products.

Tetraspan 6% is iso-oncotic:
Tetraspan 6% is an iso-oncotic solution, i.e. the increase in the
intravascular plasma volume is equivalent to the infused volume.

Instructions for use for infusion under pressure of Tetraspan
in:

Administration should begin immediately after connecting the container
to the administration set.

Ecoflac plus and Ecobag plastic container:
If it is wished to have a very rapid infusion under pressure, all air must
be removed from both the plastic packagings and the infusion set before
the infusion is instituted to prevent the risk of an air embolism during the
infusion. An infusion under pressure should be given with a pressure cuff.

Ecobag®

Ecoflac® plus

Use as soon as the primary packaging is opened. Any unused contents
should be discarded.

c

v

c

v

c
– Connect the infusion set.
– Place the container upright.
– Open the roller clamp, expel the air from the container and fill half the
drip chamber with liquid.
– Turn the container upside down and prime the infusion tube free from
air bubbles.
– Close the roller clamp.

c
– Connect the infusion set.
– Place the container upright.
– Open the roller clamp, expel the air from the container and fill half the
drip chamber with liquid.
– Turn the container upside down and prime the infusion tube free from
air bubbles.
– Close the roller clamp.

v
– Place the Ecobag bag in a pressure cuff.
– Build up pressure.
– Open the roller clamp and start the infusion.

v
– Place the Ecoflac plus bottle in a pressure cuff.
– Build up pressure.
– Open the roller clamp and start the infusion.

B|BRAUN
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B. Braun Melsungen AG
34209 Melsungen
Germany

13.03.14 09:58

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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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