Consumer medicine information

Medical Air

Air

BRAND INFORMATION

Brand name

Coregas Medical Air

Active ingredient

Air

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Medical Air.

What is in this leaflet

Please read this leaflet carefully before you receive this treatment. It provides a summary of the information known about your treatment. If you have any questions or are unsure about anything, ask your doctor.

Remember, this treatment is for you. It may harm someone else if they receive it even if their symptoms appear to be the same as yours. So do not give this treatment to anybody else.

Keep this leaflet. You may wish to refer to it again.

What Medical Air is used for

Medical Air is used as a replacement for the normal air you breathe in (atmospheric air). It is used when the atmospheric air has been contaminated by fumes, vapours or gases which may irritate you or are dangerous to your health when breathed in. In ventilators and incubators, it provides clean and controlled air flow.

Medical Air is also used as a carrier gas for volatile anaesthetics during surgery.

Before you take Medical Air

If you are not sure if you should be taking Medical Air, talk to your doctor.

There are no special circumstances which would stop you taking Medical Air.

Remember, air supports combustion, so there should be no smoking or any naked lights when Medical Air is in use.

Medical Air does not interact with any other types of medicine you may be taking and will not be affected by any food or drink.

Treatment with Medical Air on its own will not affect your ability to drive.

How to take Medical Air

Your doctor, or nurse, will decide how much Medical Air you need and how it is taken.

What to do if you take too much

As Medical Air is the same as the atmospheric air you breathe in normally, you cannot take too much.

While you are taking Medical Air

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Side effects

There are no side effects after taking Medical Air. However, tell your doctor as soon as possible if you do not feel well while you are taking Medical Air.

After taking Medical Air

Medical Air is the same as the atmospheric air you breathe in there are no adverse effects after taking Medical Air on its own.

Storage

Medical Air is supplied to the hospital, clinic or doctor and they will be responsible for ensuring the container is stored in accordance with the manufacturer’s instructions.

Disposal

Medical Air is supplied to the hospital or clinic or doctor and they will be responsible for ensuring the container is returned to the manufacturer.

Product Description

What it looks like

Medical Air is a colourless, odourless gas supplied in a pressurised gas cylinder with a valve. The gas cylinder contains only Medical Air.

The gas cylinders’ colour code is a white body with a black & white triangle shoulder (plus 2 x “N”), as determined by AS 4484.

Cylinder sizes include 2.8L, 9.5L, 23L, 50L, 6 pack 300L and 12 pack 600L as measured by nominal water capacity.

Ingredients

Active
Air - 100 % v/v.

Manufacturer/Distributor/ Supplier:

Coregas Pty. Ltd.
66 Loftus Road.
Yennora. NSW. 2161
Australia

AUST R 27160

This leaflet was prepared in June 2013.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Coregas Medical Air

Active ingredient

Air

Schedule

Unscheduled

 

1 Name of Medicine

Air.

2 Qualitative and Quantitative Composition

Medical Air contains approximately 21% oxygen, 78% nitrogen and 1% argon with trace contents of other inert gases (xenon, neon, krypton).
The nitrogen, argon and trace gases quoted above are inert, but the oxygen in air is essential to life for its cellular respiratory function.

3 Pharmaceutical Form

Medicinal gas.
Colourless, odourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

As replacement for atmospheric air. Carrier gas for volatile anaesthetics.

4.2 Dose and Method of Administration

Use in adults, the elderly and children. For respiratory use.

Instruction for use/handling.

Care is needed in the handling and use of Medical Air gas cylinders.
Refer to the respective S.D.S and the "caution" section of the product label.
Refer to manufacturer for cleaning guidelines.

Preparation for use.

1. Ensure that the connecting face on the yoke, manifold or regulator, etc., is clean and the sealing washer or 'O'-ring, where fitted, is in good condition.
2. Cylinder valves must be opened slowly.
3. Only the appropriate regulator should be used for the particular gas concerned.
4. Cylinder valves and any associated equipment must never be lubricated and must be kept free from oil and grease.

Leaks.

1. Should gas leaks occur, this will usually be evident by a hissing noise.
2. Leaks can be found by spraying the suspected area (cylinder inlet and/or valve spindle) with an approved gas leak test solution.
3. There are no user serviceable parts associated with the valves fitted, so do not attempt to correct any problems with leakage from any part of the valve itself. Quarantine leaking gas cylinders (in a well ventilated area), apply a warning sticker and, when empty, return them to Coregas for serving/ repair.
4. Sealing or jointing compounds must never be used to deal with a gas leak.
5. Never use excessive force when connecting equipment to cylinders.

Handling of cylinders.

1. Cylinders should be handled with care and not knocked or allowed to fall.
2. Cylinders should only be moved with the appropriate size and type of cylinder trolley (pallet jack).
3. When in use, cylinders should be firmly secured to suitable restraining equipment.
4. Cylinders containing liquefiable gas must always be used, transported and stored in vertical position.
5. Medical gases must only be used for medicinal purposes.
6. Smoking and naked lights must not be allowed within the vicinity of cylinders or pipeline outlets.
7. After use, cylinder valves should be closed using moderate force only and the pressure in the regulator, manifold, etc. released.
8. Immediately return used cylinders to the used cylinder store for return to Coregas.

4.3 Contraindications

None.

4.4 Special Warnings and Precautions for Use

When Medical Air is intended for use in a room in which magnetic resonance imaging (MRI) is being performed, all medical air cylinders and associated equipment must be considered to potentially contain ferromagnetic materials. Steel cylinders do contain a substantial quantity of ferromagnetic material and must not be used in proximity to MRIs under any circumstances.
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.
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.
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.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

Children differ from adults in more than just size: they have for example different breathing patterns, tidal volumes and airways geometry. Careful attention should be brought to the features to be applied to the driving gas, in case of mechanical ventilation or nebulisation in children and infants.
See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

None.
(Category A)
Medical Air does not adversely affect pregnancy.
 Medical Air does not adversely affect lactation.

4.7 Effects on Ability to Drive and Use Machines

None.

4.8 Adverse Effects (Undesirable Effects)

None.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Not applicable.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Under conditions of normal atmospheric pressure, the pharmacodynamic effects of air are essentially those of respiration, oxygen carriage and cellular metabolism.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

Genotoxicity.

Not applicable.

Carcinogenicity.

Not applicable.

6 Pharmaceutical Particulars

6.1 List of Excipients

None.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Shelf life is according to appropriate Australian Standards.

6.4 Special Precautions for Storage

Medical Air cylinders should be kept out of the reach of children.
Air supports combustion.
The normal precautions required in the storage of medical gas cylinders as described below are applicable.
Cylinders should be stored under cover, preferably inside, kept dry and clean and not subjected to extremes of heat or cold.
Cylinders should not be stored near stocks of combustible materials or exposed to artificial sources of heat.
Warning notices prohibiting smoking and naked lights must be posted clearly.
Emergency services should be advised of the location and nature of the cylinder store.
Medical cylinders should be segregated by medical gas type and identified as such within the store.
Full and empty cylinders should be stored separately. Full cylinders should be used on an "first in/ first out" basis.
Cylinders must not be re-painted. Cylinder markings must not be obscured. Product labels must not be removed. Foreign objects and attachments must not be affixed when returning cylinders.
All gas cylinders should be stored vertically. C size cylinders are traditionally as well stored horizontally.
Precautions should be taken to protect cylinders from theft and/or interference.
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 of chains.
Whether empty or full, all cylinders in the storage area must be equipped with their valve protection caps and valve closed.

6.5 Nature and Contents of Container

Medical Air is supplied in aluminium or steel gas cylinders with a pin index valve, suitable for the filling pressure applied for the product.
The types of cylinders normally used are specified in Table 1.

Notes.

Cylinders conform to AS 2030.1.
Cylinder valves conform to AS 2473.1 and AS 2473.3.
The cylinders are colour coded conforming to AS 4484.
The colour code for medical air is a white body with black and white quadrants on the shoulder.

6.6 Special Precautions for Disposal

Immediately return used cylinders to the used cylinder store for return to Coregas.

6.7 Physicochemical Properties

Medical 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).
Constituents:

Chemical structure.

Molecular formula.

Nitrogen.

N2.

Oxygen.

O2.

Argon.

Ar.

Molecular weight.

Nitrogen.

28.02.

Oxygen.

32.00.

Argon.

39.95

CAS number.

Nitrogen.

7727-37-9.

Oxygen.

7782-44-7.

Argon.

7440-37-1.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes