Consumer medicine information

Air Liquide Healthcare Medical Oxygen (v/v Bulk Liquid) and Medical Oxygen (gas medicinal)

Oxygen

BRAND INFORMATION

Brand name

Air Liquide Australia Limited Medical Oxygen

Active ingredient

Oxygen

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Air Liquide Healthcare Medical Oxygen (v/v Bulk Liquid) and Medical Oxygen (gas medicinal).

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.
  1. You are pregnant or intend to become pregnant.
  2. You are breastfeeding or wish to breastfeed.

Care should be taken when using Medicinal Oxygen because it is stored at high pressure in the gas cylinder.

Medicinal Oxygen helps fires to start and burn. You MUST consider your safety in areas where oxygen can concentrate, as this increases the risk of fire.

Please discuss this with your doctor if you have any questions.

Taking other medicines

Advise your doctor if you are being treated with bleomycin or amiodarone (Cordarone X®). You must tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

If you have a dry nose or other problems, please speak to your chemist or doctor. DO NOT use petroleum jelly (Vaseline®) or any other products around your nose, on or near the equipment.

How to use Medicinal Oxygen

Medicinal Oxygen should only be used under the supervision of your doctor or healthcare professional.

How much to use and how to use it

The amount of Medicinal Oxygen you need will be decided by your doctor. It is given by breathing it through a mask or nasal prongs.

If you are elderly or have lung problems, you may need a lesser amount of Medicinal Oxygen. Your doctor will decide this for you.

Follow all directions given to you by your doctor carefully, and do not modify the flow of Medicinal Oxygen.

If you do not understand the instructions, ask your doctor for help.

How long to use it?

Your doctor will decide how long you need to use Medicinal Oxygen.

If you use too much (overdose)

As Medicinal Oxygen is given to you under the supervision of your doctor, anaesthetist, ambulance officer, dentist or nurse, it is very unlikely you will receive an overdose.

If you have any questions, ask your doctor.

After you have used Medicinal Oxygen

Things you must not do

You must not smoke, or be near naked flames such as candles, gas stoves etc or sources of fire such as matches or lighters.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are using Medicinal Oxygen. If you experience being sleepy all the time, you may be suffering from over administration. Contact your doctor for advice.

Tell your doctor if you have any of the following and they worry you:

  • Soreness in the chest with dry cough or any breathing difficulties.
  • Problems with eyesight
  • Dry nose, mouth or sore ears
  • Nausea

These side effects are usually mild.

Tell your doctor immediately if you have any of the following:

  • Breathing problems
  • Convulsions

These are serious side effects and you may need urgent Medicinal attention. Serious side effects are rare.

If any of the above happens, tell your doctor immediately or go to casualty at your nearest hospital

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After using Medicinal Oxygen

Storage

Medicinal Oxygen is stored as a compressed gas in cylinders.

For safety, store cylinders in well ventilated areas and not in small enclosed spaces.

Disposal

Do not discard empty or damaged cylinders.

All cylinders are to be returned to the supplier whose details are printed on the product label.

Product Description

What it looks like

Medicinal Oxygen (O2) is an odourless, colourless gas supplied in all white cylinders (white body with a white shoulder). Cylinder sizes include 0.16, 0.27, 0.46, 0.47, 0.59, 0.76, 1.00, 1.50, 4.10, 4.20, 10.30, 41.20, 41.70, 63.00, 82.40, and 123.60 (m3). Medicinal Liquid Oxygen is stored in in the bulk liquid form and then supplied via a reticulated gas distribution system within healthcare facilities which is available in the gaseous form from the wall outlet.

Ingredients

Active Ingredient:

Oxygen: ≥ 99.5 % v/v min

Excipients:

None

Name and Address of Sponsor & Supplier

Air Liquide Australia Limited
Royal Domain Centre
Level 9, 380 St Kilda Road
Melbourne VIC 3004
Australia

Australian Registration Number

Oxygen - AUST R 32749 (Compressed)

Oxygen – AUST R 32744 (Liquid)

This leaflet was prepared on July 2019

Version Number: 1

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Air Liquide Australia Limited Medical Oxygen

Active ingredient

Oxygen

Schedule

Unscheduled

 

Boxed Warnings

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 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

4.9 Overdose

In oxygen intoxication there may be pulmonary symptoms of chest tightness, dry cough, and pain on inspiration. Care must be taken where symptoms cannot present (e.g. intensive care) since the onset of objective evidence for pulmonary oxygen toxicity occurs late in its development (see Section 4.8 Adverse Effects (Undesirable Effects)).
The oxygen therapy should be reduced or, if possible, stopped, and symptomatic treatment should be started in order to maintain vital functions (e.g. artificial ventilation/assisted ventilation should be given if the patient shows signs of failing respiration).
For information on management of overdose, contact the Poison Information Centre on 131126 Australia.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. O = O.
CAS number. 77282-44-7.
Composition complies with the current European Pharmacopoeia specification for oxygen.
Purity: greater than or equal to 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.
Appearance: odourless, colourless gas.
Molecular weight: 32.
Boiling point: -183.1°C (at 1 bar).
Density: 1.335 kg/m (at 15°C).
Combustion: Non-flammable, strongly supports combustion.
Pharmacotherapeutic group: GASMED, gas, medical.
ATC code: V03AN01.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

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