VOLULYTE 6%

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

potassium chloride, Quantity: 0.3 g/L; sodium chloride, Quantity: 6.02 g/L; hydroxyethyl starch 130/0.4, Quantity: 60 g/L; magnesium chloride hexahydrate, Quantity: 0.3 g/L; sodium acetate trihydrate, Quantity: 4.63 g/L

Pieejams no:

Fresenius Kabi Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Hydroxyethyl starch 130/0.4,magnesium chloride hexahydrate,potassium chloride,sodium chloride,Sodium acetate trihydrate

Zāļu forma:

Injection, intravenous infusion

Kompozīcija:

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

Ievadīšanas:

Intravenous Infusion

Vienības iepakojumā:

cartons containing 15 and 20 500 mL bags

Receptes veids:

Not scheduled. Not considered by committee

Ārstēšanas norādes:

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

Produktu pārskats:

Visual Identification: Volulyte (HES 130/0.4 in a balanced electrolyte solution) is a clear to slightly opalescent solution, colourless to slightly yellow.; Container Type: Bag; Container Material: Plastic; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2011-08-26

Lietošanas instrukcija

Page 1 of 2
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
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
VOLULYTE
You must NOT use this product if
you:

are critically ill to be admitted to
intensive care unit.

have
too
much
fluid
in
your
body and you have been told
that
you
have
a
condition
known as hyperhydration

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)

suffer from bleeding within or
around
the
brain
(intracranial
bleeding)

are allergic (hypersensitive) to
hydroxyethyl starch or any of
the other ingredients.

have
coagulation
or
bleeding
disorder

have severe liver disease

have
too
high
sodium,
potassium or chloride levels in
your blood

have a severe blood infection
Your
doctor
may
need
to
take
special precautions and will decide
whether you can receive Volulyte if
you suffer fr

Produkta apraksts

AUSTRALIAN PRODUCT INFORMATION -VOLULYTE
® 6%
(HYDROXYETHYL
STARCH 130/0.4, MAGNESIUM CHLORIDE HEXAHYDRATE, POTASSIUM
CHLORIDE, SODIUM ACETATE TRIHYDRATE, SODIUM CHLORIDE IN A
BALANCED ELECTROLYTE SOLUTION)
Page 1 of 15
1 NAME OF MEDICINE
Hydroxyethyl starch 130/0.4
Magnesium chloride hexahydrate
Potassium chloride
Sodium acetate trihydrate
Sodium chloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
Amount (L)
Hydroxyethyl starch 130/0.4
60.0 g
(Molar substitution: 0.38 – 0.45)
(Mean molecular weight: 130,000 Da)
Sodium chloride
6.02 g
Sodium acetate trihydrate
4.63 g
Potassium chloride
0.30 g
Magnesium chloride
hexahydrate
0.30 g
Electrolytes
Amount (L)
Sodium (Na
+
)
137.0 mmol
Potassium (K
+
)
4.0 mmol
Magnesium (Mg
2+
)
1.5 mmol
Chloride (Cl
-
)
110.0 mmol
Acetate (CH
3
COO
-
)
34.0 mmol
Titratable acidity:
< 2.5 mmol NaOH/L
For the full list of excipients, see Section 6.1 List of excipients.
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.
3 PHARMACEUTICAL FORM
Injection, intravenous infusion.
Volulyte (HES 130/0.4 in a balanced electrolyte solution) is a clear
to slightly opalescent
solution, colourless to slightly yellow.
The use of Volulyte 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 15
Osmolality:
approx. 260 - 310 mOsm/kg
water
Theoretical osmolarity:
286.5 mosm/l
pH:
5.7 – 6.5
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 Volulyte 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 Volulyte should be restricted to the initial phase of volume
resuscitation with a
maximum duration of use of 24 hours.
Administratio