Consumer medicine information

Aeris Medical E.P. Grade Compressed Air

Air

BRAND INFORMATION

Brand name

Aeris Medical E.P. Grade Compressed Air

Active ingredient

Air

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Aeris Medical E.P. Grade Compressed Air.

What is in this leaflet

This leaflet answers some common questions about Aeris Medical (Aeris) Medical Air.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Aeris Medical Air against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Aeris Medical Air is used for

Aeris Medical Air is for use only by or under the supervision of qualified medical practitioners.

This medicine is used for normal respiration. It is used with anaesthetics and medicines for nebulisation.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use Aeris Medical Air

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Ensure your hands are clean and free from oil or grease before using.

How to use Aeris Medical Air

Read and follow all the safety directions and instructions for use provided with the air cylinder.

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

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

How much to use

Use as prescribed by your doctor.

How to use it

Use regulator and equipment compatible with contents and pressure.

Do not open cylinder valve unless an appropriate authorised pressure- reducing device is attached to the cylinder valve.

The cylinder valve is not a metering device.

Open valve slowly and shut after use.

Inhale using self-contained or compressed air breathing apparatus or a face mask or tracheal tube.

Keep and use in a well-ventilated secure area.

Do not smoke when using.

When to use it

Use as prescribed by your doctor.

How long to use it

Continue taking your medicine for as long as your doctor tells you.

If you forget to use it

Use it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

Not applicable.

While you are using Aeris Medical Air

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using this medicine.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine It may affect other medicines used during surgery.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen. If possible, your doctor will gradually reduce the amount you use each day before stopping the medicine completely.

Never use as a substitute for compressed oxygen.

Do not smoke.

Do not use oil or grease on any part of the equipment.

Do not use oil-based moisturiser when using a facemask.

Things to be careful of

Check with your doctor or pharmacist before using a moisturiser with a facemask.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aeris Medical Air.

Ask your doctor or pharmacist to answer any questions you may have.

After using Aeris Medical Air

Storage

Keep your air cylinder in a cool dry place where the temperature stays below 30°C.

Keep the air cylinder where children cannot reach it.

Store away from combustible, flammable, oily, greasy and tarry materials.

Do not apply any oily, greasy substances to any part of the cylinder, valve or any attached devices.

Do not heat cylinder.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, return the air cylinder to the place where you bought it.

Product description

What it looks like

Aeris Medical Air is a colourless, odourless gas contained in a metal cylinder that has a white body and black and white shoulder, which is the Australian Standard colour coding for medical grade air. All medical air cylinders contain high pressure and should only be used in conjunction with authorised medical devices.

Ingredients

Aeris Medical Air contains 100% air as the active ingredient.

There are no other ingredients.

Manufacturer

Aeris Medical Medical Air is manufactured in Australia by:

Supagas Pty Ltd
23 Commercial Drive, Dandenong South VIC 3175

This leaflet was prepared in April 2012. This leaflet was formatted in October 2017.

AUST R 155229

Published by MIMS November 2019

BRAND INFORMATION

Brand name

Aeris Medical E.P. Grade Compressed Air

Active ingredient

Air

Schedule

Unscheduled

 

1 Name of Medicine

Air.

2 Qualitative and Quantitative Composition

Each cylinder of the medicinal gas contains 100% v/v Air E.P. grade, consisting of:
Nitrogen 78.1% v/v;
Oxygen 20.9% v/v;
Argon 0.9% v/v.

3 Pharmaceutical Form

Medicinal gas.
Odourless, colourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

Air for medical use.
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

Dosage.

There is no distinction in the use of medical air between age groups.

Method of administration.

For breathing purposes, medical air is administered by various means, commonly by self-contained or compressed air breathing apparatus.
In anaesthesia medical air is administered from a cylinder and valve assembly or pipeline through a face mask or endotracheal tube.

4.3 Contraindications

Medical air is not indicated when medical oxygen or other medical gases are required (unless as a carrier). See Section 4.4 Special Warnings and Precautions for Use.

4.4 Special Warnings and Precautions for Use

General.

Medical air should never be given unless it contains 20.4 - 21.4% oxygen. Will support combustion.
Check the following before use:
Medical air cylinders are fitted with an appropriate pin index valve in accordance with Australian Standards (see Section 4.2 Dose and Method of Administration, Handling and instructions for use (below)). Only medical air devices with compatible connection to the pin index valve can be used.
Cylinder pressure may be used as an indicator of the quantity of gas remaining in the cylinder.

Use of gas cylinders.

The normal precautions required for the storage and use of medical air cylinders are applicable. Because the contents are under pressure and are sometimes hazardous, there are special safety regulations for handling bottled gases. These include chaining bottles to prevent falling and breaking, proper ventilation to prevent injury or death in case of leaks and signage to indicate the potential hazards. Installing and replacing gas cylinders should be done by trained personnel.
Under no circumstances should oils or grease be used to lubricate any part of the compressed gas medical air cylinder or the associated equipment used to deliver the gas to the patient.
Cylinders must be kept out of reach of children.
Cylinders must not be exposed to extremes of temperature. Always ensure hands are clean and free from any oils or grease.
See Section 4.2 Dose and Method of Administration, Handling and instructions for use (below); Section 6.4 Special Precautions for Storage.
Additional information is contained in the Safety Data Sheet from the Sponsor.

Handling and instructions for use.

Cylinders must be fitted with an appropriate pressure-reducing device; see Section 4.4 Special Warnings and Precautions for Use. Consult the information provided by the Sponsor about operating procedures for the cylinders. Do not use medical air if the cylinder is damaged or has the tamper evident plastic seal removed.
All personnel handling medical air should have adequate knowledge of:
Properties of the gas.
Correct operating procedures for the cylinder.
Precautions and actions to be taken in the event of an emergency.
Under no circumstances should oils or grease be used to lubricate any part of the compressed gas medical 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.
When compressed medical air cylinders are in use, ensure that they are:
Only used for medicinal purposes.
Only moved with the appropriate size and type of trolley or handling device.
Handled with care and not knocked violently or allowed to fall.
Firmly secured to a suitable cylinder support when in use.
Not used in the vicinity of persons smoking or near naked lights.
When the compressed medical air cylinder is empty ensure that:
The cylinder valve is closed using moderate force only and the pressure in the regulator or Tailpipe released, and the valve outlet cap, where fitted, is replaced.
Empty cylinders are immediately returned to the empty cylinder store for return to the supplier.

Use in the elderly.

Use of medical air is not differentiated between age groups. Medical air does not adversely affect the elderly.

Paediatric use.

Use of medical air is not differentiated between age groups. Medical air does not adversely affect children.

Effects on laboratory tests.

Not applicable.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Medical air does not adversely affect fertility.
(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

Medical air does not affect ability to drive or use machinery.

4.8 Adverse Effects (Undesirable Effects)

There are no known adverse effects of medical air.

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

The pharmacology of medical air is the same as that for atmospheric air.
Pharmacotherapeutic group: GASMED, Gas, Medical. ATC Code: V03AN.

Clinical trials.

None stated.

5.2 Pharmacokinetic Properties

The pharmacokinetics of medical air are the same as those for atmospheric air.

5.3 Preclinical Safety Data

Genotoxicity.

Medical air does not increase genotoxic risk.

Carcinogenicity.

Medical air does not increase carcinogenic risk.

6 Pharmaceutical Particulars

6.1 List of Excipients

None applicable.

6.2 Incompatibilities

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

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). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30 degrees Celsius.
The normal precautions required in the storage and use of medical gas cylinders are applicable. Also see Section 4.4 Special Warnings and Precautions for Use.

6.5 Nature and Contents of Container

Aluminium alloy (Size C) or steel (Sizes D, E and G) gas cylinder with brass valve closure. The CR, DR and ER gas cylinders are supplied with integrated analogue regulator.

Pack sizes.

See Table 1.

6.6 Special Precautions for Disposal

Empty cylinders are immediately returned to the empty cylinder store for return to the supplier.

6.7 Physicochemical Properties

Compressed medical gas 100% v/v Air E.P. grade complies with current European Pharmacopoeial specifications:
Oxygen (O2): 20.4% to 21.4% v/v.
Carbon dioxide: Not more than 500 ppm v/v.
Carbon monoxide: Not more than 5 ppm v/v.
Sulfur dioxide: Not more than 1 ppm v/v.
Oil: Not more than 0.1 mg/m3.
Nitrogen monoxide and nitrogen dioxide: Not more than 2 ppm v/v in total.
Water: Not more than 67 ppm v/v.
Appearance: Odourless, colourless gas.
Molecular mass: 29.0 g/mol.
Relative density (Air = 1): 1.0.
Density (101.325 kPa at 15°C): 1.22 kg/m3.
Boiling point: -194°C.
Solubility in water (101.33 kPa at 20°C): 0.018 cm3/cm3.
Combustion characteristics: Non-flammable. Inert.
Constituents:

Chemical structure.


Molecular formula.

Nitrogen: N2;
Oxygen: O2;
Argon: Ar.

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