Medical Air – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Medical Air

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Air Ph.Eur. 100%

3 PHARMACEUTICAL FORM

Inhalation gas

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

As replacement for atmospheric air. Carrier gas for volatile anaesthetics

4.2 Posology and method of administration

Use in adults, including the elderly and children

For respiratory use

4.3 Contraindications

None

4.4 Special warnings and precautions for use

None

4.5 Interaction with other medicinal products and other forms of interaction

None

4.6 Pregnancy and lactation

Air does not adversely affect pregnancy or lactation

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

None

4.9 Overdose

Not applicable

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Air is a colourless, odourless gas with molecular weight 29.0, boiling point -194°C (at 1 bar) and density 1.225 kg/m³ (at 15°C and 1013mb). Atmospheric air contains approximately 21% oxygen, 78% nitrogen and 1% argon with trace contents of other inert gases (xenon, neon, krypton). The nitrogen is absolutely inert, but the oxygen in air is essential to life for its cellular respiratory function.

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

There are no additional data of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None

6.2 Incompatibilities

None

6.3 Shelf life

Five years

6.4 Special precautions for storage

Cylinders should be kept out of the reach of children.

Air support 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 near sources of heat.
• Warning notices prohibiting smoking and naked lights must be posted clearly.
• Emergency services should be advised of the location of the cylinder store.
• Medical cylinders containing different gases should be segregated and identified within the store.
• Full and used cylinders should be stored separately. Full cylinders should be used in strict rotation.
• Cylinders must not be repainted, have any markings obscured or labels removed.
• F size cylinders and larger should be stored vertically E size cylinders and smaller should be stored horizontally.
• Precautions should be taken to protect cylinders from theft.

6.5 Nature and contents of container

Air is supplied in a gas cylinder with valve, suitable for the pressure required for the product.

The types of cylinders normally used are specified in the following table.

Note: (1) Cylinder valves conform to BS341 (non pin-index – except the 4bar outlet valves which are proprietary) and BS EN 850:1997 (pin-index) The cylinders are colour coded as specified in BS 1319 (1976) and ISO 32 (1977).

The colour for air is a grey body with a quartered black and white shoulder.

6.6 Special precautions for disposal

Care is needed in the handling and use of air gas cylinders.

Preparation for use

1. 1. Cylinder valves should be opened momentarily prior to use to blow any foreign matter out of the outlet.
2. 2. Ensure that the connecting face on the yoke, manifold or regulator is clean and the sealing washer or ‘O’ ring where fitted is in good condition.
3. 3. Cylinder valves must be opened slowly.
4. 4.

   Only the appropriate regulator should be used for the particular gas concerned.

   N.B. Where the 4bar outlet, Schraeder connector valve is fitted, no additional regulator is necessary.

5. 5. Pipelines for medical gases should be installed in accordance with the conditions set out in HTM 2022.
6. 6. Cylinder valves and any associated equipment must never be lubricated and must be kept free from oil and grease.

Leaks

1. 1. Should leaks occur this will usually be evident by a hissing noise.
2. 2. Leaks can be found by brushing the suspected area with an approved leak test solution.
3. 3. There are no user serviceable parts associated with these valves, do not attempt to correct any problems with leakage from any part of the valve itself. Label any faulty containers, and return them to Linde Gas for repair.
4. 4. Sealing or jointing compounds must never be used to cure a leak
5. 5. Never use excessive force when connecting equipment to cylinders.

Use of Cylinders

1. 1. Cylinders should be handled with care and not knocked violently or allowed to fall.
2. 2. Cylinders should only be moved with the appropriate size and type of trolley.
3. 3. When in use cylinders should be firmly secured to a suitable cylinder support.
4. 4. Cylinders containing liquefiable gas must always be used vertically with the valve uppermost.
5. 5. Medical gases must only be used for medicinal purposes.
6. 6. Smoking and naked lights must not be allowed within the vicinity of cylinders or pipeline outlets.
7. 7. After use cylinder valves should be closed using moderate force only and the pressure in the regulator or tailpipe released.
8. 8. When only a small amount of gas remains in a cylinder, the cylinder valve must be closed. It is important to leave a small residual pressure in each cylinder after use, in order to protect the inside of the cylinder from contamination.
9. 9.

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

   Linde Gas.

7 MARKETING AUTHORISATION HOLDER

Air Liquide Limited

Station Road

Coleshill

Birmingham

West Midlands

B46 1JY

8 MARKETING AUTHORISATION NUMBER

PL 15929/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

04/02/1998 / 16/04/2003

10 DATE OF REVISION OF THE TEXT

15/07/2010