Volulyte 6%

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Hydroxyethyl starch 130/0.4 60 g/L; Magnesium chloride hexahydrate 0.3 g/L;  ; Potassium chloride 0.3 g/L; Sodium acetate trihydrate 4.63 g/L;  ; Sodium chloride 6.02 g/L;  ;  ;  

Disponibbli minn:

Fresenius Kabi New Zealand Limited

INN (Isem Internazzjonali):

Hydroxyethyl starch 130/0.4 60 g/L

Dożaġġ:

6 %

Għamla farmaċewtika:

Solution for infusion

Kompożizzjoni:

Active: Hydroxyethyl starch 130/0.4 60 g/L Magnesium chloride hexahydrate 0.3 g/L   Potassium chloride 0.3 g/L Sodium acetate trihydrate 4.63 g/L   Sodium chloride 6.02 g/L       Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Unitajiet fil-pakkett:

Bag, plastic, 500mL Freeflex infusion bag, 15 dose units

Klassi:

General sale

Tip ta 'preskrizzjoni:

General sale

Manifatturat minn:

Fresenius Kabi Austria GmbH

Indikazzjonijiet terapewtiċi:

Treatment of hypovolaemia due to acute blood loss when chrystlloids 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.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Bag, plastic, 500mL Freeflex infusion bag - 15 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 500mL Freeflex infusion bag - 20 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 20 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 30 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 35 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 40 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze

Data ta 'l-awtorizzazzjoni:

2011-12-02

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
NZ Data Sheet - VOLUVEN
® 6% - September 2021
Page 1 of
15
1 PRODUCT NAME
VOLULYTE
®
6% solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
Amount(L)
Hydroxyethyl starch 130/0.4
60.0 g
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.
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.
NEW ZEALAND DATA SHEET
NZ Data Sheet - VOLUVEN
® 6% - September 2021
Page 2 of
15
Chemical structure
Molar substitution:
0.4 (0.38 – 0.45)
Weight average molecular weight:
130,000 ± 20,000 Dalton
Chemical name:
Poly (O-2 hydroxyethyl) starch
ACTIVE SUBSTANCE
CAS NUMBER
Hydroxyethyl Starch 130/0.4
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
3 PHARMACEUTICAL FORM
Solution for infusion.
Volulyte (HES 130/0.4 in a balanced electrolyte solution) is a clear
to slightly opalescent solution, colourless
to slightly yellow.
Osmolality:
approx. 260 - 310 mOsm/kg water
Theoretical osmolarity
286.5mosm/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.