Consumer medicine information

What is in this leaflet?

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

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

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

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

What Medical Oxygen is used for?

Medical 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, Medical Oxygen can be used in your home.

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

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

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

Before you use Medical Oxygen

When you must not use it

WARNING: MEDICAL OXYGEN BOOSTS BURNING AND MAY INCREASE THE CHANCE OF FIRE.

DO NOT use Medical Oxygen if:

a. You are smoking.

b. You are near open flames.

c. You are cooking.

Do not use Medical 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 Medical Oxygen therapy.
3. You have or have had any other health problems or medical conditions, including:

• Severe lung disease such as chronic bronchitis or emphysema.

4. You are pregnant or intend to become pregnant.
5. You are breastfeeding or wish to breastfeed.
6. Care should be taken when using Medical Oxygen because it is stored at high pressure in the gas cylinder.

Medical 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 Medical Oxygen

Medical 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 Medical 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 Medical 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 Medical 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 Medical Oxygen.

If you use too much (overdose)

As Medical 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 Medical 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 Medical 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 medical 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 Medical Oxygen

Storage

Medical Oxygen is stored as a compressed gas in cylinders by your doctor, dentist, ambulance, hospital or at your home. Be sure not to store the cylinders in small, closed spaces.

Disposal

All cylinders are the property of BOC. Empty cylinders are to be returned to the manufacturer.

Product Description

What it looks like

Medical Oxygen is an odourless, colourless gas supplied in cylinders with a black body and white shoulder, or in an all white fibre wrapped cylinder.

Cylinder gas volumes, litres at 101.3kPa 15°C, include:
490L - “C”, 630L - “CD”, 1640L - “D”, 4100L - “E”, 8300L - “G”, .

Ingredients

Oxygen – 99.5 % v/v min

Manufacturer/Distributor/ Supplier

BOC Medical
Riverside Corporate Park
10 Julius Ave.
North Ryde NSW 2113

AUST R 34468 (Compressed oxygen)

AUST R 34471 (oxygen liquid)

This leaflet was prepared on 14 March 2008.

Published by MIMS September 2019

1 Name of Medicine

Oxygen.

2 Qualitative and Quantitative Composition

Contains 99.5% v/v oxygen.
Complies with current British Pharmacopoeial specifications, purity not less than 99.5%.
Purity: Not less than 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.
There are no excipients.

3 Pharmaceutical Form

Compressed medical gas for medicinal use.
Odourless, colourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

For respiratory delivery where there is a requirement for medical 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 concentration 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 dose 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 in the inhaled gas mixture (FiO₂; avoid > 0.6=60% O₂ in the inhaled 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 concentrations 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 the 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 for 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. (Section 4.2 Dose and Method of Administration.)

General.

Warning.

Check the following before use.

Use of gas cylinders.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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.

Amiodarone.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Under normal conditions, oxygen does not interfere with consciousness, however patients who require continuous oxygen support will require individual assessment, taking their entire medical situation into account for evaluating their ability to drive or operate machinery. Also 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 described in standard texts include:

Eye disorders.

ENT.

CNS disorders.

Respiratory.

Gastrointestinal.

General.

Reporting suspected adverse effects.

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 the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: GASMED, Gas, Medical. ATC Code: V03AN01.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

None.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medical product. Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

Shelf life is according to appropriate Australian Standards.

6.4 Special Precautions for Storage

Storage is according to appropriate Australian Standards.
Medical Oxygen cylinders should be:
stored under cover in a well ventilated area, kept dry and clean and not subjected to extremes of heat or cold;
not stored near stocks of combustible materials or near sources of heat;
stored separately from industrial and other non-medical cylinders;
stored to maintain separation between full and empty cylinders;
used in strict rotation so that cylinders with the earliest filling date are used first;
stored separately from other medical cylinders within the store.
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.

Handling and instructions for use.

Warning.

6.5 Nature and Contents of Container

Presentation.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

Physical characteristics.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes