AIR LIQUIDE AUSTRALIA LIMITED Medical Oxygen 100% v/v Gas Medicinal

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

oxygen, Quantity: 1 L/L

Tilgængelig fra:

Air Liquide Healthcare Pty Ltd

INN (International Name):

Oxygen

Lægemiddelform:

Gas, medicinal

Sammensætning:

Excipient Ingredients:

Indgivelsesvej:

Inhalation

Enheder i pakken:

41.70, 1.00 (TAKE 02), 1.50, 0.59 (TAKE 02), 123.60, 1.00, 0.47, 0.76, 4.10 (TAKE 02), 41.20, 82.40, 10.30, 0.27, 0.59, 0.46, 63

Recept type:

Not scheduled. Not considered by committee

Terapeutiske indikationer:

.

Produkt oversigt:

Visual Identification: ; Container Type: Gas Cylinder

Autorisation status:

Registered

Autorisation dato:

1991-11-01

Indlægsseddel

AIR LIQUIDE HEALTHCARE
MEDICAL OXYGEN (V/V BULK LIQUID) AND MEDICAL OXYGEN (GAS
MEDICINAL)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
Medicinal Oxygen. It contains
only some information, and
does not take the place of
talking to your doctor or
appropriate healthcare
professional.
All medicines may assist you,
but sometimes there are risks.
Your doctor or healthcare
professional has weighed up
the risks of you using Medicinal
Oxygen against the benefits
they expect it will have for you.
If you have any questions
about using Medicinal Oxygen,
ask your doctor.
Keep this leaflet with you as
you may want to read it again.
WHAT MEDICINAL OXYGEN IS
USED FOR?
Medicinal 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, Medicinal
Oxygen can be used in your
home.
Medicinal Oxygen works by
increasing uptake and
concentrating oxygen in your
tissues.
Your doctor may prescribe
Medicinal Oxygen for another
purpose. Ask your doctor if you
have any questions about why
Medicinal Oxygen has been
prescribed for you.
This medicine is available only
with a doctor's prescription.
BEFORE YOU USE MEDICINAL
OXYGEN
When you must not use it:
WARNING: MEDICINAL
OXYGEN WILL BOOST
BURNING AND MAY INCREASE
THE CHANCE OF FIRE.
DO NOT use Medicinal Oxygen
if:
a. You are smoking.
b. You are near open flames.
c. You are cooking.
Do not use Medicinal 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 Medicinal Oxygen therapy.
3. You have or have had any
other health problems or
Medicinal 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.
Care should be taken when

Produktets egenskaber

Medicinal Oxygen PIv2 AU-1001-28032018
1
AUSTRALIAN PRODUCT INFORMATION
AIR LIQUIDE LIMITED MEDICAL OXYGEN 100% V/V GAS MEDICINAL
(OXYGEN)
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
1
NAME OF THE MEDICINE
Medicinal Oxygen, Air Liquide, Gas for Inhalation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains ≥ 99.5% v/v Oxygen
There are no excipients in medicinal oxygen
3
PHARMACEUTICAL FORM
Medicinal Oxygen is a compressed colourless gas administered by
inhalation as prescribed.
Compressed Medicinal Oxygen is supplied cylinder with an all-white
body and a pin-index or
integrated valve in accordance with Australian Standards.
Compressed Medicinal Oxygen is supplied in pressurised gas cylinders
of varying sizes and pressures.
See Section 6.5 Nature and Contents of Container
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For respiratory delivery where there is a requirement for medicinal
oxygen to treat or prevent
hypoxemia.
Medicinal Oxygen PIv2 AU-1001-28032018
2
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 concentrations of oxygen,
between 21% and 100%, as determined by the prescriber after full
clinical assessment. Most delivery
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.