PIL
July 2012
CMI FOR VOLULYTE 6%
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VoluCMI120712 -cleanVoluCMI050510-clean.doc
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VOLULYTE
®
6%
_ _
Hydroxyethyl Starch 130/0.4 in a balanced electrolyte solution
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common questions about Volulyte.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. All medicines have
risks and benefits. Your doctor
has weighed the risks of you given
Volulyte against any benefits they
expect it will have for you.
PLEASE READ THIS LEAFLET CAREFULLY.
IF YOU HAVE ANY QUESTIONS OR ARE
UNSURE ABOUT ANYTHING, PLEASE
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED
TO READ IT AGAIN.
WHAT IS VOLULYTE USED
FOR
Volulyte is an infusion solution
containing an artificial starch.
Due to limited availability, blood
and blood containing products are
not always used to replace fluid
losses and are only used where
absolutely essential. Smaller fluid
losses are now replaced using
“artificial” solutions called plasma
substitutes or volume replacement
fluids. Volulyte is one of these
solutions.
It may be necessary to maintain
your circulating blood volume for
example, during operation, or if
you had suffered a burn or trauma.
BEFORE YOU ARE GIVEN
VOLULYTE
You must NOT use this product if:
•
You have too much fluid in your
body and you have been told
that you have a condition
known as hype
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PRODUCT INFORMATION
NAME OF MEDICINE
VOLUVEN
®
6%
Hydroxyethyl Starch 130/0.4
Molar substitution 0.38 – 0.45
Average Molecular weight: 110,000 - 150,000 Dalton
Mean molecular weight (Mw) 130,000
Chemical name: Poly (O-2 hydroxyethyl) starch
Voluven contains 60g_/_L of Hydroxyethyl Starch 130/0.4 and 9g/L sodium chloride
(Na
+
154mmol, Cl
-
154 mmol) as active ingredients. _ _
Structural formula
O
OR
RO
OR
1
O
O
OR
RO
OR
1
O
OR
1
OR
RO
O
O
OR
1
OR
RO
O
O
O
OR
RO
OR
1
O
)
(
n
R = -H, -CH
2
CH
2
OH
R
1
= -H, -CH
2
CH
2
OH or glucose units
Chemical Abstracts Service (CAS) registry name: [9005-27-0]
Hydroxyethyl Starch 130/0.4 is a white to yellowish white, odourless and tasteless,
amorphous powder, readily soluble in water at room temperature, soluble in DMSO,
practically insoluble in most organic solvents.
Hydroxyethyl starch (HES) is a derivative of amylopectin, which is a highly branched
compound of starch. In humans and animals amylopectin is rapidly hydrolysed by
amylase. In order to reduce the metabolic degradation, glucose residues of the
amylopectin are reacted with ethylene oxide. The hydroxyethyl groups can be
introduced at three positions (C
2
,C
3
,C
6
) of the glucose residues. The degree of
substitution and the substitution pattern expressed by the C
2
/C
6
ratio determines the
enzymatic degradation of HES. Voluven is characterised by its molar substitution, by its
molecular weight and the C
2
/C
6
ratio.
Molecular weight (Mw): The molecular weight indicates
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