HELIOX 28 oxygen/helium 28/72% v/v medical gas mixture

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

oxygen, Quantity: 28 % v/v; helium, Quantity: 72 % v/v

Tilgængelig fra:

BOC Limited

INN (International Name):

Helium,Oxygen

Lægemiddelform:

Gas, medicinal

Sammensætning:

Excipient Ingredients:

Indgivelsesvej:

Inhalation

Enheder i pakken:

2.4L, 23.8L

Recept type:

Not scheduled. Not considered by committee

Terapeutiske indikationer:

Heliox28 is indicated in treatment of hypoxia associated with airway obstruction.

Produkt oversigt:

Visual Identification: Colourless gas; Container Type: Gas Cylinder

Autorisation status:

Registered

Autorisation dato:

2003-08-21

Indlægsseddel

1
HELIOX
28
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please
read
this
leaflet
carefully
before using your Heliox
28
. It is a
summary
of
the
important
information you need to know about
using
Heliox
28
.
If
you
have
any
questions
or
are
not
sure
about
anything,
ask
your
health
professional looking after you.
This medicine has been prescribed
for you and you should not allow
anyone else to use it. It may harm
them even if their symptoms are the
same as yours.
WHAT IS HELIOX
28
Heliox
28
is a compressed medicinal
gas mixture of 28% Oxygen and
72%
Helium
filled
into
cylinders
under
high
pressure
and
manufactured by BOC Limited.
The registration for Heliox
28
is held
by
BOC
Limited,
10
Julius
Ave,
North
Ryde.
The
registration
number for this product is AUST R
90662.
Heliox
28
is supplied in two cylinder
sizes containing 510 litres (CD size)
and 3500 litres (ED size).
WHAT
IS
HELIOX
28
USED
FOR?
Heliox
28
is a very light gas mixture
and
will
flow
through
lungs
with
obstructions much more easily than
other medical gases. It is used to
provide a breathing gas mixture for
patients suffering from respiratory
or
airway
obstruction
such
as
bronchitis or asthma to get oxygen
into the blood stream.
Heliox
28
is used to supply adequate
Oxygen
to
the
lungs
to
assist
a
patient to breath if part of their lung
fails to expand.
BEFORE USING HELIOX
28
Heliox
28
should not be used where
its
physical
properties
might
aggravate
the
patient's
conditions,
such as:
•
_artificial, traumatic or _
_spontaneous pneumothorax _
•
_sub-cutaneous emphysema _
Tell your doctor if you are pregnant
as use of Helox
28
during pregnancy
is not recommended unless clearly
necessary.
Heliox
28
has not been found to have
an effect on ability to drive or use of
machinery.
Under
no
conditions
should
you
smoke when using Heliox
28
or use
the
cylinders
near
naked
flames
such as open fires.
USING HELIOX
28
Heliox
28
is administered through a
non-rebreathing
mask
which
is
connected through tubing directly to
the compressed gas cylinder or via
a

Produktets egenskaber

Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION -
HELIOX 28
OXYGEN 28% V/V AND HELIUM 72% V/V
1
NAME OF THE MEDICINE
Helium and Oxygen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heliox28 is a homogenous gas mixture of oxygen 28% v/v and helium 72%
v/v
Oxygen is the active ingredient
Specification
The specifications for each of the main components are presented
separately.
_Oxygen _
Complies with the requirements of the current European Pharmacopoeia
monograph for Oxygen.
Oxygen
99.5% v/v minimum
Carbon dioxide
300 ppm v/v maximum
Carbon monoxide
5 ppm v/v maximum
Water (vapour)
67 ppm v/v maximum
_Helium _
Complies with BOC specification for Medical Helium.
Helium
99.99% v/v minimum
Hydrocarbons as Methane
1 ppm v/v maximum
Carbon monoxide
5 ppm v/v maximum
Water (vapour)
67 ppm v/v maximum
There are no excipients.
3
PHARMACEUTICAL FORM
Compressed medical gas mixture (for medicinal use only).
Oxygen is a colourless, odourless and tasteless gas. Helium is a
colourless, odourless, non-flammable
gas.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Heliox28 is indicated in treatment of hypoxia associated with airway
obstruction.
Page 2 of 6
4.2
D
OSE AND METHOD OF ADMINISTRATION
Routes of administration
Heliox28 is administered by inhalation through the lungs. Heliox28
should only be administered by
medical personnel trained in the appropriate techniques and in an
adequate environment.
The method of administration is to supply the medical gas mixture
directly from the outlet of the
medical cylinder valve, via an appropriate flexible hose connected to
either a face mask or cannula, a
demand valve with face mask or cannula attached, a nebuliser or
inhaler with face mask attached or a
ventilator.
Cylinders should only be used in conjunction with special Heliox28 gas
pressure regulators and demand
valves.
Safety of long term administration of Heliox28 has not been studied.
4.3
C
ONTRAINDICATIONS
Heliox28 should not be used where its high diffusivity might
exacerbate conditions, such as with artificial,
traumatic or sponta