BOC GASES REFRIGERATED LIQUID OXYGEN MEDICAL GRADE(S) gas medicinal

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxygen, Quantity: 100 % v/v

Available from:

BOC Limited

INN (International Name):

Oxygen

Pharmaceutical form:

Gas, medicinal

Composition:

Excipient Ingredients:

Administration route:

Inhalation

Units in package:

22320 m3 (size VIE 30,000), 840 m3 (size VIE 1,500), 12020 m3 (size VIE 15,000), 5500 m3 (size VIE 7,000), 2460 m3 (size VIE 3,0

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

For respiratory delivery where there is a requirement for medical oxygen to treat or prevent hypoxemia.

Product summary:

Visual Identification: Colourless gas; Container Type: Not Applicable

Authorization status:

Registered

Authorization date:

1992-01-02

Patient Information leaflet

1
MEDICAL OXYGEN 99.5%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Medical Oxygen. It
contains only some information, and
does not take the place of talking to
your doctor or appropriatehealthcare
professional.
All medicines may assist you, but
sometimes
there are
risks.
Your
doctor
or
healthcare
professional
has
weighed
up
the
risks
of
you
using Medical Oxygen against the
benefits they expect it will have for
you.
If
you
have
any
questions
about
using
Medical
Oxygen,
ask
your
doctor.
Keep this leaflet with you as you may
want to read it again.
WHAT MEDICAL OXYGEN IS
USED FOR?
Medical
Oxygen
is
used
for
breathing, to treat or prevent oxygen
deficiency.
It
is
usually
given
by
a
doctor,
anaesthetist,
dentist,
ambulance
officer or nurse via a mask or nasal
prongs. When directed by a doctor,
Medical Oxygen can be used in your
home.
Medical Oxygen works by increasing
uptake and concentrating oxygen in
your tissues.
Your doctor may prescribe Medical
Oxygen
for
another
purpose.
Ask
your
doctor
if
you
have
any
questions
about
why
Medical
Oxygen has been prescribed for you.
This medicine is available only with a
doctor's prescription.
BEFORE YOU USE MEDICAL
OXYGEN
_WHEN YOU MUST NOT USE IT_
WARNING:
MEDICAL
OXYGEN
BOOSTS
BURNING
AND
MAY
INCREASE
THE
CHANCE
OF
FIRE.
DO NOT USE MEDICAL OXYGEN IF:
A. YOU ARE SMOKING.
B. YOU ARE NEAR OPEN FLAMES.
C. YOU ARE COOKING.
Do not use Medical Oxygen if the
cylinder
is
damaged
or
has
the
tamper
evident
plastic
seal
removed.
_BEFORE YOU START TO USE IT_
_ _
YOU MUST TELL YOUR DOCTOR IF:
1. YOU ARE A SMOKER.
2. YOU HAVE HAD ANY REACTION TO
MEDICAL OXYGEN THERAPY.
3. YOU HAVE OR HAVE HAD ANY
OTHER HEALTH PROBLEMS OR MEDICAL
CONDITIONS, INCLUDING:
•
Severe
lung
disease
such
as
chronic
bronchitis
or
emphysema.
4. YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
5. YOU ARE BREASTFEEDING OR WISH
TO BREASTFEED.
6.
CARE
SHOULD
BE
TAKEN
WHEN
USING MEDICAL OXYGEN BECAUSE IT
IS STORED AT HIGH PRESSURE IN THE
GAS CYLINDER.
MEDICAL
OXYGEN

Summary of Product characteristics

Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION –
BOC GASES REFRIGERATED LIQUID OXYGEN MEDICAL GRADE(S)
WARNING: OXYGEN AIDS AND INCREASES COMBUSTION.
OXYGEN STRONGLY SUPPORTS COMBUSTION (INCLUDING SOME MATERIALS WHICH DO
NOT NORMALLY BURN IN AIR).
SMOKING IS PROHIBITED WHEN MEDICAL OXYGEN IS IN USE, AND NO NAKED
FLAME IS ALLOWED. THERE IS A HIGH
RISK OF SPONTANEOUS COMBUSTION IF OXYGEN COMES INTO CONTACT WITH OILS,
GREASES AND TARRY SUBSTANCES.
_SEE SECTION_
_ _
_4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
_ _
_AND SECTION 6.4_
_ _
_SPECIAL PRECAUTIONS FOR _
_STORAGE_
_._
1
NAME OF THE MEDICINE
Oxygen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 99.5% v/v oxygen
Complies with current British Pharmacopoeial specifications, purity
not less than 99.5%.
Purity
Not less than 99.5% v/v
Carbon dioxide
Not more than 300 ppm v/v
Carbon monoxide
Not more than 5 ppm v/v
Water
Not more than 67 ppm v/v
There are no excipients.
3
PHARMACEUTICAL FORM
Compressed medical gas for medicinal use.
Odourless, colourless gas.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For respiratory delivery where there is a requirement for medical
oxygen to treat or prevent
hypoxemia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Medical oxygen is administered by inhalation through the lungs. The
major exception is when a
metered supply is fed into the oxygenator of an extracorporeal
circulation of a cardio-pulmonary
bypass system.
Inhaled Medical Oxygen must be administered using an appropriate
pressure reduction device and
equipment such as mask or nasal prongs to deliver the required
inspired concentration of oxygen,
between 21% and 100%, as determined by the prescriber after full
clinical assessment. Most delivery
Page 2 of 9
systems for adults result in an inspired oxygen concentration of 60%
or less. Inhaled oxygen may
require humidification when treatment duration is longer than an hour.
Standard texts and clinical protocols should be consulted for the
oxygen requirements specific to the
underlying condition and the clinical status of