Consumer medicine information

What is in this leaflet?

This leaflet answers some common questions about Medicinal Air. It contains only some information, and does not take the place of talking to your doctor or appropriate healthcare professional.

If you have any questions about using Medicinal Air, ask your doctor.

Keep this leaflet with you as you may want to read it again.

What Medicinal Air is used for?

Medicinal Air is indicated for respiratory assistance.

• For normal respiration
• In anaesthetic equipment as a carrier gas during surgery
• For nebulisation of inhaled drugs when oxygen supplementation is not required.

It is usually given by a doctor, dentist, ambulance officer or nurse via a mask or nasal prongs.

Your doctor may prescribe Medicinal Air for another purpose. Ask your doctor if you have any questions about why Medicinal Air has been prescribed for you.

Before you use Medicinal Air

When you must not use it

WARNING:

MEDICINAL AIR WILL BOOST BURNING AND MAY INCREASE THE CHANCE OF FIRE.

DO NOT SMOKE

DO NOT PLACE NEAR FLAMES or HEAT SOURCES

DO NOT USE OIL OR GREASE

Do not use Medicinal Air if the cylinder is damaged

Before you start to use it

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

Secure cylinders by appropriate means (chains, hooks) in order to keep them upright and prevent them from falling over.

Do not use an adaptor or connector to connect devices that do not normally fit.

Never stand facing the valve outlet, always stand opposite the pressure reducing valve some distance behind the cylinder

Check before first use that the tamper evident seal is intact.

How to use Medicinal Air

Medicinal Air should only be used under the supervision of your doctor or healthcare professional for ventilatory or nebulisation purposes.

How much to use and how to use it

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

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

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 Air.

After you have used Medicinal Air

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

There are no known side effects for medicinal air

Tell your doctor as soon as possible if you do not feel well while you are using Medicinal Air.

Tell your doctor immediately if:

You notice anything that is making you feel unwell or go to casualty at your nearest hospital.

After using Medicinal Air

Storage

Medicinal Air 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 on the product label.

Product Description

What it looks like

Medicinal Air is an odourless, colourless gas.

Ingredients

Active Ingredient:

Air

Excipients:

None

Dosage form

Regulated gas inhalation in prescribed litres per minute (L/min).

Cylinder Packages

As a minimum each cylinder package contains 100 % medicinal Air.

Package:

• Steel or aluminium cylinders
• White body
• black and white shoulder quadrants.

Not all cylinder packages and volumes may be marketed

Name and Address of Sponsor

Air Liquide Healthcare Pty Limited

Air Liquide Australia Pty Ltd
Royal Domain Centre
380 St Kilda Road
Melbourne, VIC, 3004

Australian Registration Number

Air - AUST R 97748 (Compressed)

This leaflet was prepared on May 2019.

Version Number: 1

Published by MIMS December 2019

1 Name of Medicine

Medicinal Air 100% v/v.

2 Qualitative and Quantitative Composition

Medicinal Air contains approximately 20.4% v/v - 21.4% v/v oxygen, 78% nitrogen and 1% argon with trace elements of other gases (xenon, neon, krypton).

Excipients.

3 Pharmaceutical Form

Compressed medicinal gas for inhalation.

4 Clinical Particulars

4.1 Therapeutic Indications

The current therapeutic applications of Medicinal Air are:
For normal respiration.
In anaesthetic equipment as a carrier gas during surgery.
For nebulisation of inhaled drugs when oxygen supplementation is not required.

4.2 Dose and Method of Administration

Medicinal Air is administered as follows:
For breathing purposes supported by a ventilator.
In anaesthetic equipment as a carrier gas.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

Precautions for use in children and infants.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

General handling and instructions for use.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Adverse Effects (Undesirable Effects)

None known. There are no adverse interactions with other drugs.
Adverse effects due to use of medicinal air are rather related to the technical use of mechanical ventilation or nebulization.

4.9 Overdose

Over dosage is not an issue as Air Medicinal is compressed and purified air.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: gas for inhalation.
ATC code: V03AN.
The active substance, air, is one of the basic essentials of maintenance of life. The pharmacodynamic effect of medicinal air is linked to the physiological respiration.
Air normally contains approximately 21% oxygen, equivalent (at normal barometric pressure) to a partial pressure of 159 mmHg. The aim of the respiratory physiology is to maintain enough available oxygen for the metabolic demands of the tissues.

Clinical efficacy.

Clinical trials.

5.2 Pharmacokinetic Properties

The uptake, distribution and metabolism of air are driven by the actual respiratory physiology in the body. During breathing, oxygen is moved with inspired air to the lung, where it diffuses into blood. The blood then transfers oxygen to the tissues: O₂ diffuses into mitochondria (structures in cells responsible for energy production) and is available for the metabolic needs. The CO₂ produced at this place follows the opposite way.

5.3 Preclinical Safety Data

No known significant data.

6 Pharmaceutical Particulars

6.1 List of Excipients

No excipients.

6.2 Incompatibilities

Where moisturising preparations are required for use with a facemask or in nasal passages etc., avoid using oil based creams. If in doubt, check with the manufacturer to ensure that the product of choice is suitable for use with medicinal air.
Under no circumstances should oils or grease be used to lubricate any part of the medicinal air cylinder or the associated equipment used to deliver the gas to the patient. Always ensure hands are clean and free from any oils or grease.
Electrical equipment capable of sparking or generating extreme heat should not be used in the vicinity of patients receiving oxygen.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Keep cylinders away from sources of artificial heat.
Do not use oil or grease.
Use with suitable pressure reducing regulator.
All regulations concerning handling of pressure vessels must be followed.
Air is a comburent gas, which can form flammable and explosive mixtures with combustibles gases.
Gas cylinders must be stored in storage area specially provided for the purpose. The storage area must be ventilated.
If they are placed along a personnel passageway, they must be prevented from falling by means or chains.
Full cylinders and empty cylinders have to be storage in separated and identified zones. The storage area cannot reach a temperature up to 50°C.
Whether empty or full, all cylinders in the storage area must be equipped with their valve protection caps and valve closed.
Cylinders must not be subjected to violent impact. If, after an accidental collision, a cylinder exhibits local deformation or a notch, even shallow, it should be considered as hazardous and removed from use. It must be returned to the supplier with notification of the damage.

6.5 Nature and Contents of Container

Medicinal Air is supplied in aluminium or steel cylinders with a white body with a shoulder containing a black and white sector.
Medicinal Air is presented in gas cylinders and cylinder packs with the following gas content nominal fill pressure. (See Table 1.)
All cylinders and packs are fitted with pin index valves.

6.6 Special Precautions for Disposal

Not applicable.

6.7 Physicochemical Properties

Medicinal Air is a colourless, odourless gas with a molecular weight of 29.0, a boiling point of 194°C (at 101.325 kPa) and a density of 1.225 kg/m³ (at 15°C and 101.325 kPa).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes