VOLUVEN 6% hydroxyethyl starch 130/0.4 500 mL solution for intravenous infusion bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydroxyethyl starch 130/0.4, Quantity: 60 g/L

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Hydroxyethyl starch 130/0.4

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide

Administration route:

Intravenous

Units in package:

10 x 500 mL

Prescription type:

Not Scheduled after consideration by Committee

Therapeutic indications:

Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. The use of Voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

Product summary:

Visual Identification: Clear solution.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-11-13

Patient Information leaflet

Page 1 of 2
VOLUVEN
® 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
Voluven. 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
Voluven
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 VOLUVEN USED
FOR
Voluven
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. It is
not a substitute for blood or blood
containing products.
BEFORE YOU ARE GIVEN
VOLUVEN
You must NOT use this product if
you:

are
critically
ill
to
be
admitted
to
intensive
care
unit.

are
allergic
to
hydroxyethyl
starches or any of the other
ingredients
as
listed
at
the
end of this leaflet.

have
bleeding
of
the
brain
(cerebral haemorrhage)

have
too
high
sodium
or
chloride levels in your blood

have a severe blood infection

have severe liver disease

have coagulation or bleeding
disorder

have been told that you have
pulmonary oedema where too
much fluid is in your lungs

have been told that you have
a congestive heart failure (a
condition in which your heart
cannot pump enough blood to
other organs of your body)

have kidney failure and you
produce little or no urine and if
this
is
not
caused
by
low
blood volumes (hypovolemia)

are
receiving
dialysis
treatment (an artificial kidney
treatment)
Before
you
use
Voluven,
you
must also tell your doctor if you
have problems with your heart,
liver, lung or have severe lack of
fluid (dehydration). Special care
has to be taken while this product
is given to you. Infusion of large
quantitie

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - VOLUVEN
® 6% (HYDROXYETHYL
STARCH 130/0.4 IN A BALANCED ELECTROLYTE SOLUTION)
Page 1 of 12
1 NAME OF MEDICINE
Hydroxyethyl Starch 130/0.4
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
Amount (L)
Hydroxyethyl Starch 130/0.4
60g
Excipient
NaCl (Na
+
154 mmol, Cl
-
154 mmol)
9g
Hydroxyethyl starch is characterised by its molar substitution,
molecular weight and the C
2
/C
6
ratio. See
sections 5.2 PHARMACOKINETIC PROPERTIES and 6.7 PHYSICOCHEMICAL
PROPERTIES.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for injection.
Voluven 6% isotonic solution is colourless, clear and slightly acidic
(pH 4.0-5.5).
Osmolality approx 304 mOsm/kg water
Theoretical osmolarity 308 mosm/l
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypovolaemia due to acute blood loss when crystalloids
alone are not considered sufficient.
The use of Voluven is not a substitute for the appropriate use of
packed red blood cells or fresh frozen
plasma.
4.2
DOSE AND METHOD OF ADMINISTRATION
For intravenous infusion.
Use of Voluven should be restricted to the initial phase of volume
resuscitation with a maximum duration of
use of 24 hours.
Administration of Voluven may cause anaphylactic reactions that may
manifest as acute hypotension. In all
patients, the initial 10-20 mL of Voluven should be infused slowly,
keeping the patient under close observation
for anaphylactic/anaphylactoid reactions manifesting as unexpected
hypotension, or the development of
wheeze or rash. (Please also refer to sections 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE
and 4.8. ADVERSE EFFECTS (UNDESIRABLE EFFECTS).
The daily dose and rate of infusion depend on the patient’s blood
loss, on the maintenance or restoration of
haemodynamics and on the haemodilution (dilution effect).
The use of Voluven in critically ill patients, including those with
severe sepsis, is
associated with an increased risk of death or the need for renal
replacement therapy.
Page 2 of 12
In clini