Aeris Medical Medical EP Grade Compressed Air

MIMS Revision Date: 01 February 2021

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.
Use in pregnancy. (Category A)
Medical air does not adversely affect pregnancy.
Use in lactation. 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.

Date of First Approval

29 January 2014

Date of Revision

01 December 2020

Summary Table of Changes