Consumer medicine information

Air Liquide Healthcare Medical Oxygen (v/v Bulk Liquid) and Medical Oxygen (gas medicinal)

Oxygen

BRAND INFORMATION

Brand name

Air Liquide Australia Limited Medical Oxygen

Active ingredient

Oxygen

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Air Liquide Healthcare Medical Oxygen (v/v Bulk Liquid) and Medical Oxygen (gas medicinal).

What is in this leaflet?

This leaflet answers some common questions about Medicinal Oxygen. It contains only some information, and does not take the place of talking to your doctor or appropriate healthcare professional.

All medicines may assist you, but sometimes there are risks. Your doctor or healthcare professional has weighed up the risks of you using Medicinal Oxygen against the benefits they expect it will have for you.

If you have any questions about using Medicinal Oxygen, ask your doctor.

Keep this leaflet with you as you may want to read it again.

What Medicinal Oxygen is used for?

Medicinal Oxygen is used for breathing, to treat or prevent oxygen deficiency.

It is usually given by a doctor, anaesthetist, dentist, ambulance officer or nurse via a mask or nasal prongs. When directed by a doctor, Medicinal Oxygen can be used in your home.

Medicinal Oxygen works by increasing uptake and concentrating oxygen in your tissues.

Your doctor may prescribe Medicinal Oxygen for another purpose. Ask your doctor if you have any questions about why Medicinal Oxygen has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you use Medicinal Oxygen

When you must not use it:

WARNING: MEDICINAL OXYGEN WILL BOOST BURNING AND MAY INCREASE THE CHANCE OF FIRE.

DO NOT use Medicinal Oxygen if:

a. You are smoking.

b. You are near open flames.

c. You are cooking.

Do not use Medicinal Oxygen if the cylinder is damaged or has the tamper evident plastic seal removed.

Before you start to use it

You must tell your doctor if:

  1. You are a smoker.
  2. You have had any reaction to Medicinal Oxygen therapy.
  3. You have or have had any other health problems or Medicinal conditions, including:
  • Severe lung disease such as chronic bronchitis or emphysema.
  1. You are pregnant or intend to become pregnant.
  2. You are breastfeeding or wish to breastfeed.

Care should be taken when using Medicinal Oxygen because it is stored at high pressure in the gas cylinder.

Medicinal Oxygen helps fires to start and burn. You MUST consider your safety in areas where oxygen can concentrate, as this increases the risk of fire.

Please discuss this with your doctor if you have any questions.

Taking other medicines

Advise your doctor if you are being treated with bleomycin or amiodarone (Cordarone X®). You must tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

If you have a dry nose or other problems, please speak to your chemist or doctor. DO NOT use petroleum jelly (Vaseline®) or any other products around your nose, on or near the equipment.

How to use Medicinal Oxygen

Medicinal Oxygen should only be used under the supervision of your doctor or healthcare professional.

How much to use and how to use it

The amount of Medicinal Oxygen you need will be decided by your doctor. It is given by breathing it through a mask or nasal prongs.

If you are elderly or have lung problems, you may need a lesser amount of Medicinal Oxygen. Your doctor will decide this for you.

Follow all directions given to you by your doctor carefully, and do not modify the flow of Medicinal Oxygen.

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

How long to use it?

Your doctor will decide how long you need to use Medicinal Oxygen.

If you use too much (overdose)

As Medicinal Oxygen is given to you under the supervision of your doctor, anaesthetist, ambulance officer, dentist or nurse, it is very unlikely you will receive an overdose.

If you have any questions, ask your doctor.

After you have used Medicinal Oxygen

Things you must not do

You must not smoke, or be near naked flames such as candles, gas stoves etc or sources of fire such as matches or lighters.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are using Medicinal Oxygen. If you experience being sleepy all the time, you may be suffering from over administration. Contact your doctor for advice.

Tell your doctor if you have any of the following and they worry you:

  • Soreness in the chest with dry cough or any breathing difficulties.
  • Problems with eyesight
  • Dry nose, mouth or sore ears
  • Nausea

These side effects are usually mild.

Tell your doctor immediately if you have any of the following:

  • Breathing problems
  • Convulsions

These are serious side effects and you may need urgent Medicinal attention. Serious side effects are rare.

If any of the above happens, tell your doctor immediately or go to casualty at your nearest hospital

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After using Medicinal Oxygen

Storage

Medicinal Oxygen is stored as a compressed gas in cylinders.

For safety, store cylinders in well ventilated areas and not in small enclosed spaces.

Disposal

Do not discard empty or damaged cylinders.

All cylinders are to be returned to the supplier whose details are printed on the product label.

Product Description

What it looks like

Medicinal Oxygen (O2) is an odourless, colourless gas supplied in all white cylinders (white body with a white shoulder). Cylinder sizes include 0.16, 0.27, 0.46, 0.47, 0.59, 0.76, 1.00, 1.50, 4.10, 4.20, 10.30, 41.20, 41.70, 63.00, 82.40, and 123.60 (m3). Medicinal Liquid Oxygen is stored in in the bulk liquid form and then supplied via a reticulated gas distribution system within healthcare facilities which is available in the gaseous form from the wall outlet.

Ingredients

Active Ingredient:

Oxygen: ≥ 99.5 % v/v min

Excipients:

None

Name and Address of Sponsor & Supplier

Air Liquide Australia Limited
Royal Domain Centre
Level 9, 380 St Kilda Road
Melbourne VIC 3004
Australia

Australian Registration Number

Oxygen - AUST R 32749 (Compressed)

Oxygen – AUST R 32744 (Liquid)

This leaflet was prepared on July 2019

Version Number: 1

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Air Liquide Australia Limited Medical Oxygen

Active ingredient

Oxygen

Schedule

Unscheduled

 

1 Name of Medicine

Medicinal oxygen, air liquide, gas for inhalation.

2 Qualitative and Quantitative Composition

Contains ≥ 99.5% v/v Oxygen.
There are no excipients in medicinal oxygen.

3 Pharmaceutical Form

Medicinal Oxygen is a compressed colourless gas administered by inhalation as prescribed. Compressed Medicinal Oxygen is supplied cylinder with an all-white body and a pin-index or integrated valve in accordance with Australian Standards.
Compressed Medicinal Oxygen is supplied in pressurised gas cylinders of varying sizes and pressures. See Section 6.5 Nature and Contents of Container.

4 Clinical Particulars

4.1 Therapeutic Indications

For respiratory delivery where there is a requirement for medicinal oxygen to treat or prevent hypoxemia.

4.2 Dose and Method of Administration

Medical Oxygen is administered by inhalation through the lungs. The major exception is when a metered supply is fed into the oxygenator of an extracorporeal circulation of a cardio-pulmonary bypass system.
Inhaled Medical Oxygen must be administered using an appropriate pressure reduction device and equipment such as mask or nasal prongs to deliver the required inspired concentrations of oxygen, between 21% and 100%, as determined by the prescriber after full clinical assessment. Most delivery systems for adults result in an inspired oxygen concentration of 60% or less. Inhaled oxygen may require humidification when treatment duration is longer than an hour.
Standard texts and clinical protocols should be consulted for the oxygen requirements specific to the underlying condition and the clinical status of the individual patient. It is essential to monitor ventilation, arterial oxygen saturation, and the clinical effect of the treatment.
In general, the aim of treatment is to ensure, by adjusting the oxygen fraction in the inhaled air (FiO2), so that the oxygen partial pressure in arterial blood (PaO2) does not fall below 60 mmHg or that the oxygen saturation of haemoglobin in arterial blood does not fall below 90%. The dose (FiO2) must be adjusted according to each patients individual needs, taking into account the risk of oxygen toxicity. The general recommendation is to use the lowest does necessary to achieve the desired result of treatment. In cases of pronounced hypoxia, oxygen fractions that can involve a risk of oxygen toxicity may be indicated (see Section 4.9 Overdose).
In short-term treatment with oxygen, the oxygen concentration i.e. the fraction of the inhaled gas mixture (FiO2; avoid > 0.6 = 60% O2 in the inhalation gas mixture) should be maintained so as to achieve an arterial oxygen partial pressure (PaO2) > 60 mmHg.
In patients with chronic respiratory disorders with hypercapnia, there is a risk of reduced respiratory drive with high oxygen concentrations, and low controlled oxygen concentrations (24%-28%) are generally used, with incremental increases based on individual clinical assessment and arterial blood value.
Treatment of neonates with oxygen may be required but must be strictly monitored, so that the oxygen concentration may be reduced when the patient's condition allows. For neonates (full-term and preterm) the appropriate institutional protocols, based on full clinical assessment, should be followed. The lowest effective concentration should be sought in order to achieve an adequate oxygenation appropriate for neonates.
In the emergency/acute setting, the usual dose for adults to treat or prevent acute oxygen deficiency is 3-4 litres per minute when using nasal prongs or 5-15 litres per minute with a mask.
Oxygen treatment must be continuously evaluated and the effect measured by means of PaO2 or arterial oxygen saturation.
The use of medical oxygen for hyperbaric oxygen treatment is beyond the scope of this registered therapeutic good. See specialist literature.

4.3 Contraindications

There is no formal contraindication to normobaric oxygen therapy.
Due to increased risk of fire, patients should not smoke during oxygen therapy. See Section 4.4 Special Warnings and Precautions for Use.

4.4 Special Warnings and Precautions for Use

Domiciliary oxygen therapy is not indicated for adult patients with severe airflow limitation whose main complaint is dyspnoea but who maintain a PaO2 > 60 mmHg and who show no secondary effects of chronic hypoxia, or who have not received adequate therapy of other kinds (e.g. bronchodilators and corticosteroids, treatment for right ventricular failure or have any respiratory infection). See Section 4.2 Dose and Method of Administration.
Oxygen therapy may affect the level of consciousness in a patient with hypercapnia and reduced respiratory drive. See Section 4.2 Dose and Method of Administration.

General.

Warning: oxygen aids and increases combustion.
Oxygen strongly supports combustion. Smoking is prohibited and no naked flame is allowed.
Oxygen in contact with oils, greases and tarry substances creates a highly dangerous environment due to the risk of spontaneous combustion.
Electrical equipment capable of sparking or generating extreme heat should not be used in the vicinity of patients receiving oxygen.

Check the following before use.

Oxygen cylinders must be fitted with an appropriate and lawfully supplied pressure-reducing device dedicated to use with medical oxygen and complying with Australian Standards (See Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use, Handling and instructions for use). Where this device is separate, it must match the cylinder valve pin index outlet. Where the dispensing equipment connection is separate, this must be connected by an oxygen-specific coupling.
Cylinder pressure may be used as an indicator of the quantity of gas remaining in the cylinder.

Use of gas cylinders.

Medical oxygen is stored in high pressure gas cylinders at ambient temperature. Care is needed in the handling and use of compressed medical oxygen gas cylinders. Under no circumstances should oils or grease be used to lubricate any part of the compressed gas medical oxygen cylinder or the associated equipment used to deliver the gas to the patient. 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; Section 6.4 Special Precautions for Storage. Additional information is contained in the Safety Data Sheet for Medical Oxygen from the Sponsor.
Oxygen toxicity may occur with prolonged exposure to high inspired oxygen levels. High oxygen concentrations should be given for the shortest possible time required to achieve the required clinical outcome, and reduced as soon as possible to the lowest concentrations needed to prevent or treat hypoxia.
There is evidence in the literature that the risk of oxygen toxicity can be minimised if the treatment follows these guidelines (oxygen fraction in the inhaled air/gas mixture = FiO2):
Oxygen in concentrations up to 100% (FiO2 1.0) should not be given for more than 6 hours.
Oxygen in concentrations above 60-70% (FiO2 0.6-0.7) should not be given for more than 24 hours.
Oxygen in concentrations above 40-50% (FiO2 0.4-0.5) should not be given during the next 24 hours.
Oxygen concentrations > 40% (FiO2 > 0.4) can potentially cause damage after 2 days.
Premature infants are excluded from these guidelines because retrolental fibroplasia may occur with a much lower FiO2. The lowest effective concentrations should be sought in order to achieve an adequate oxygenation appropriate for neonates (also see Section 4.2 Dose and Method of Administration).
The response to oxygen varies depending on the underlying disorder, cause of hypoxia, and clinical status of the individual patient. The clinician should consider all relevant factors in selecting the inspired oxygen concentration, flow rate, and duration of therapy, taking into account the risk of oxygen toxicity. The general recommendation is that the lowest dose - FiO2 - to achieve the desired result of therapy, a safe PaO2 must be the aim. Careful monitoring of oxygen therapy is required, with repeated clinical assessment and monitoring of inhaled oxygen concentration (FiO2) and checks of arterial oxygenation e.g. by atrial blood gas measurements (PaO2), or arterial oxygen saturations (SaO2) via pulse oximetry, as clinically appropriate.
If oxygen is mixed with other gases, its concentration in the gas mixture inhaled (FiO2) must be maintained at least at 21% in the inhaled gas. Oxygen inhaled fraction can be increased up to 100%.

Handling and instructions for use.

Warning: Medical Oxygen increases burning and the risk of fire.
Do not use medical oxygen if:
a. You are smoking;
b. You are near open flames.
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 oxygen if the cylinder is damaged or has the tamper evident plastic seal removed.
All personnel handling medical Oxygen 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.
When Compressed Medical Oxygen 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 Oxygen 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 sponsor.

Use in the elderly.

Use in the elderly is determined by clinical assessment and course of the illness. Some elderly patients with chronic severe obstructive airways disease may rely on hypoxic drive for respiration and required relatively low inspired oxygen concentrations. See Section 4.2 Dose and Method of Administration.

Paediatric use.

Special care must be observed when administering oxygen to neonates. Preterm infants are more susceptible to the direct and indirect potentially toxic effects of oxygen exposure, including retinopathy of prematurity. Clinical protocols appropriate to the condition and age of the infant should be followed, including advice for appropriate arterial oxygen saturation monitoring. Ongoing monitoring is required to achieve the targeted arterial saturation using the lowest possible inspired oxygen levels. See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

Not applicable.

4.5 Interactions with Other Medicines and Other Forms of Interactions

High oxygen fraction may further impair the damages caused by lung toxic agents.

Bleomycin.

Potentially fatal pulmonary toxicity can develop in patients treated with Bleomycin who are exposed to conventional oxygen concentrations during anaesthesia. It is recommended that oxygen concentration in Bleomycin-treated patients should where possible be limited to less than 30% (FiO2 < 0.3), with use of low concentrations (25%, FiO2 0.25) during surgery and post-operative recovery, and avoidance of pulmonary interstitial oedema by careful choice and monitoring of fluid replacement (see Bleomycin Product Information).

Amiodarone.

High dose oxygen may increase the risks of Amiodarone-induced post-operative adult respiratory distress syndrome (see Amiodarone Product Information).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Medical oxygen has not been shown to adversely affect fertility when used as clinically required.
(Category A)
Category A: when oxygen is used in pregnancy as clinically required, treating intercurrent illness and avoiding hypoxemia, at the lowest concentration for the shortest possible time.
Hyperbaric oxygen treatment during gestation in mice, rats, hamsters and rabbits let to increased resorptions and foetal abnormalities, and decreased foetal body weights. Category A does not relate to hyperbaric oxygen treatment and specialist literature should be consulted.
Pregnant woman should not be exposed to hyperbaric oxygen.
 Oxygen can be used during breast-feeding as clinically required, to treat intercurrent illness and avoid hypoxemia, at the lowest concentrations for the shortest possible time.

4.7 Effects on Ability to Drive and Use Machines

Under normal conditions, oxygen does not interfere with consciousness, however patients who required continuous oxygen support will require individual assessment, taking their entire medical situation into account for evaluating their ability to drive or operate machinery. See Section 4.4 Special Warnings and Precautions for Use.

4.8 Adverse Effects (Undesirable Effects)

Oxygen toxicity depends upon both inspired partial pressure of oxygen (a function of concentration and barometric pressure) and duration of exposure, the safe duration decreasing as the pressure increases. With 100% normobaric oxygen, symptoms of pulmonary toxicity are cough, substernal chest pain, mild dyspnoea, malaise, nausea, or transient paresthesia after 6-24 hours, substernal distress, atelectasis, decrease in vital capacity (after 18 hours) and acute respiratory distress syndrome (after 24-48 hours). Up to 2 atmospheres, pulmonary toxicity occurs before CNS toxicity; at higher pressures, the reverse applies. Symptoms of CNS toxicity include nausea, mood changes, vertigo, twitching, convulsions and loss of consciousness.
Adverse effects of oxygen exposure as descried in standard texts include:

Eye disorders.

Retinopathy of prematurity, retrolental fibroplasia in neonates, tunnel vision, myopia with hyperbaric oxygen.

ENT.

Mucosal dryness and irritation, ear or sinus trauma, tympanic membrane rupture with hyperbaric oxygen.

CNS disorders.

Drowsiness/carbon dioxide narcosis if given in high concentrations to patients with reduced sensitivity to carbon dioxide tension in arterial blood; effects of hyperbaric oxygen toxicity include vertigo, convulsions, loss of consciousness.

Respiratory.

Chest tightness, dry cough, pain on inspiration; decreased vital capacity; pneumonitis; atelectasis bronchopulmonary dysplasia in neonates; carbon dioxide retention when given in high concentrations to patients with reduced sensitivity to arterial CO2 tension. Pneumothorax or air embolism has been reported with hyperbaric oxygen.

Gastrointestinal.

Nausea.

General.

Haemolysis of red blood cells; lipid peroxidation and cell membrane damage due to chemical toxicity in any metabolising cells.
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 https://www.tga.gov.au/reporting-problems.

4.9 Overdose

In oxygen intoxication there may be pulmonary symptoms of chest tightness, dry cough, and pain on inspiration. Care must be taken where symptoms cannot present (e.g. intensive care) since the onset of objective evidence for pulmonary oxygen toxicity occurs late in its development (see Section 4.8 Adverse Effects (Undesirable Effects)).
The oxygen therapy should be reduced or, if possible, stopped, and symptomatic treatment should be started in order to maintain vital functions (e.g. artificial ventilation/assisted ventilation should be given if the patient shows signs of failing respiration).
For information on management of overdose, contact the Poison Information Centre on 131126 Australia.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The basal oxygen consumption in humans is approximately 250 mL/min for a body surface area of 1.8 m2. It is reduced by about 10% during anaesthesia and natural sleep and by about 50% for a 10°C fall in body temperature. Under normal conditions, alveolar air contains about 14% oxygen (105 mmHg) and the arterial blood has an oxygen tension of 97 mmHg. The difference, known as the alveolar-arterial oxygen tension gradient, increases with age and may be as great as 30 mmHg in a healthy elderly individual. Oxygen in the blood is primarily bound to haemoglobin. The oxygen saturation of haemoglobin in arterial blood is approximately 97%. Each gram of haemoglobin binds approximately 1.34 mL of oxygen, giving maximum capacity of about 20 mL per 100 mL of blood. A small amount, 0.3 mL, exists in solution in the same volume of blood.
The concept of "oxygen availability" can be used to quantify the amount available to the body. It can be expressed as product of cardiac output and the oxygen content of the blood. This is estimated by (cardiac output) x (Hb concentration) x (amount of oxygen carried by one gram of haemoglobin) x (% saturation of haemoglobin), plus the amount in solution.
The average healthy individual with basal oxygen consumption has no more than four minutes supply of oxygen circulating in the blood.
Oxygen is present in the atmosphere at 21% and is essential for cellular metabolism. The therapeutic use of oxygen is intended to improve, or prevent a reduction in, the oxygen content of blood leaving the lungs (or the oxygenator of a heart-lung machine).

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Inhaled oxygen is transported via the airways to the lung with the inspired air. Oxygen is absorbed in the alveoli by gas exchange resulting from the difference in partial pressure from the inspired air/gas mixture to the capillary blood. Increasing the inhaled oxygen concentration (i.e. inspired gas oxygen fraction, FiO2), is intended to compensate for problems of ventilation, diffusion and ventilation/perfusion mismatch, by increasing the alveolar partial pressure of oxygen.

Distribution.

Oxygen is transported mainly bound to haemoglobin. A small amount though is free and dissolved into plasma.

Metabolism.

The uptake of oxygen by the blood in the lungs and discharge to the tissues is determined by the oxygen dissociation curve. The characteristic sigmoid curve ensure that, at tensions between 40 and 15 mmHg, the oxygen carried in the blood from the lungs can be readily given up to the tissues. See Figure 1.
The update from the lungs is rapid, because blood flow through the capillaries, where exchange takes place, occurs in about 0.5 seconds. At rest, mixed venous blood returning to the lungs contains 13-14 mL of oxygen per 100 mL, but with severe exercise, the oxygen content may fall to 3-4 mL. In very active tissue, there is almost complete extraction of oxygen.

Excretion.

The uptake of oxygen is favoured by simultaneous loss of carbon dioxide which is 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

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

There are no excipients in Medicinal Oxygen.

6.2 Incompatibilities

Under no circumstances should oils or grease be used to lubricate any part of the compressed gas medical oxygen 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.
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 oxygen.
Oxygen in contact with oils, greases and tarry substances creates a highly dangerous environment due to the risk of spontaneous combustion.
Electrical equipment capable of sparking or generating extreme heat should not be used in the vicinity of patients receiving oxygen.
Do not expose cylinders to extremes of temperature.

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).

6.4 Special Precautions for Storage

Medicinal Oxygen should always be stored:
under cover in a well-ventilated area, kept dry and clean and not subjected to extremes of heat or cold;
not near stocks of combustible materials or near sources of heat;
separate from industrial and other non-medical cylinders;
to maintain separation between full and empty cylinders;
used in rotation so that cylinders with the earliest batch fill date are used first;
separately from other medical cylinders within a storage area.
Warning notices prohibiting smoking and naked lights must be posted clearly in the cylinder storage area and the Emergency Services should be advised of the location of the cylinder store.

6.5 Nature and Contents of Container

Medical Oxygen is supplied as a compressed gas in pressurized cylinders made of aluminium or steel.

Cylinder colour.

Medicinal Oxygen is supplied in all white cylinders. The cylinder has a white body and a white shoulder. See Table 1.
Not all cylinders sizes may be marketed.
Cylinders must be fitted with an appropriate pressure-reducing device (e.g. regulator) if not fitted with an integrated valve (VIPR) which includes a regulator and flow metering device.
Do not use medical oxygen if the cylinder is damaged or has the tamper evident seal removed when in full storage.
When in use ensure Medicinal Oxygen cylinders are:
Used only for medicinal purposes.
Moved using handing devices or trolley appropriate to the cylinder size.
Handled with care and not knocked violently or allowed to fall.
Secured to a suitable cylinder support when in use.
Not used in the vicinity of persons smoking or near naked lights or flames.
When empty ensure:
The cylinder valve is closed using only moderate force and the pressure in the regulator is released.
Replace valve caps where fitted.
Returned to the empty cylinder storage area.

6.6 Special Precautions for Disposal

Empty cylinders should be immediately returned to empty cylinder storage for return to the sponsor.
Any unused or unwanted cylinders should be returned to the sponsor for safe disposal.

6.7 Physicochemical Properties

Chemical structure.

O = O.

CAS number.

77282-44-7.
Composition complies with the current European Pharmacopoeia specification for oxygen.
Purity: greater than or equal to 99.5% v/v.
Carbon dioxide: not more than 300 ppm v/v.
Carbon monoxide: not more than 5 ppm v/v.
Water: not more than 67 ppm v/v.
Appearance: odourless, colourless gas.
Molecular weight: 32.
Boiling point: -183.1°C (at 1 bar).
Density: 1.335 kg/m (at 15°C).
Combustion: Non-flammable, strongly supports combustion.
Pharmacotherapeutic group: GASMED, gas, medical.
ATC code: V03AN01.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes