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

1 NAME OF THE MEDICINAL PRODUCT

Medical Oxygen.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxygen Ph. Eur. 100%.

3 PHARMACEUTICAL FORM

Inhalation gas.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Hypoxia of any cause. As diluent for gaseous and volatile anaesthetic agents.

4.2 Posology and method of administration

Use in adults and children

For respiratory use at concentrations of greater than 21%.

Use in neonates

When administering oxygen to neonates the inspired concentration of oxygen should not exceed 40%. (See 4.8).

Use in the elderly

When giving oxygen to elderly chronic bronchitic patients the inspired concentration of oxygen should only be raised by 1% increments and should not exceed 30%.

Instructions for use and handling of Medical Oxygen equipment

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.
5. 5. Pipelines for medical gases should be installed in accordance with the conditions set out in HTM 02.
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 Air Liquide 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 Medical Oxygen 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 liquifiable 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.

4.3 Contraindications

None.

4.4 Special warnings and precautions for use

Oxygen supports combustion and smoking should be prohibited when oxygen is in use and no naked flame should be allowed.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Pregnancy and lactation

Oxygen does not adversely affect pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Patients may experience retrosternal soreness associated with coughing and breathing difficulties after breathing pure oxygen at atmospheric pressure for several hours. This retrosternal soreness is exacerbated by smoking and exposure to cold air.

Convulsions and other central nervous system (CNS) effects may occur at two atmospheres or more, after a few hours exposure to pure oxygen. At higher pressures more rapid onset of CNS symptoms will occur.

Retrolental fibroplasia may occur in premature infants exposed to oxygen at concentrations greater than 40%.

4.9 Overdose

At two or more atmospheres pressure users may experience central nervous system toxicity including dizziness, convulsions and loss of consciousness after only 2-3 hours of exposure to pure oxygen.

Oxygen intake should be reduced or preferably stopped for a period of time and the effects will be reversed. Oxygen therapy can be restarted if desired.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Oxygen is a colourless, odourless gas with molecular weight 32, a boiling point of -183.1^oC (at 1 bar) and a density of 1.355 kg/m³ (at 15^oC and 1013mb).

Oxygen is present in the atmosphere at 21% and is an absolute necessity for life.

5.2 Pharmacokinetic properties

The uptake from the lungs is rapid because blood flow through the capillaries, where exchange takes place, occurs in about 0.5 seconds. The uptake of oxygen is favoured by the simultaneous loss of carbon dioxide which is then excreted in the expired air. Conversely the entry of carbon dioxide into the blood from the tissues facilitates oxygen transfer to the cells.

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

There are no incompatibilities with oxygen in clinical practice.

6.3 Shelf life

Five years.

6.4 Special precautions for storage

Cylinders should be kept out of the reach of children.

Oxygen is non-flammable but strongly supports combustion (including some materials which do not normally burn in air). It is highly dangerous when in contact with oils, greases, tarry substances and many plastics due to the risk of spontaneous combustion with high pressure gases.

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

Oxygen 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 ISO 407 (pin-index) (2) N.B. Cylinders with 200 bar pressure at the outlet, and should only be used on a manifold installed to HTM 02, or with a 200 bar regulator.

The colour of Medical Oxygen cylinders in the UK is in a period of change.

The colour coding of the shoulder of Medical Oxygen is white. The body of the cylinder will be either black or white.

The aim is to complete a period of change over from the black body to the white bodied cylinder. The shoulder colour of the cylinder will remain as white. This period of change will be completed by January 1st 2026.

Not all pack sizes may be marketed

6.6 Special precautions for disposal

Cylinders that are no longer required should be returned to Air Liquide.

See section 4.2 for ‘Instructions for use and handling of Medical Oxygen equipment’.

7 MARKETING AUTHORISATION HOLDER

Air Liquide Ltd

Station Road

Coleshill

Birmingham

West Midlands

B46 1JY

8 MARKETING AUTHORISATION NUMBER(S)

PL 15929/0005

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

4^th February 1998 / 17^th April 2003

10 DATE OF REVISION OF THE TEXT

10/04/2014