Consumer medicine information

Aeris Medical E.P. Grade Compressed Oxygen

Oxygen

BRAND INFORMATION

Brand name

Aeris Medical E.P. Grade Compressed Oxygen

Active ingredient

Oxygen

Schedule

Unscheduled

SUMMARY CMI

Aeris Medical Medical E.P. Grade Compressed Oxygen

Consumer Medicine Information (CMI) summary

WARNING: Oxygen strongly supports combustion (including some materials which do not normally burn in air). Do not smoke, avoid open flames and contact with oils, greases and tarry substances.

The full CMI on the next page has more details. If you are worried about using Medical Oxygen, speak to your doctor, nurse or pharmacist.

1. Why am I using Aeris Medical Medical Oxygen?

Aeris Medical Medical Oxygen contains the active ingredient Oxygen. Medical Oxygen is used to supply oxygen to the lungs and to help breathing when not enough oxygen is getting to the lungs.

For more information, see Section 1. in the full CMI.

2. What should I know before I use Aeris Medical Medical Oxygen?

If you are planning to use Medical Oxygen at home:
- Do not use if you smoke and intend to continue smoking
- Do not use if you have trouble breathing but it is not due to a lack of oxygen in the lungs
- Only use if your doctor has said it is OK for you to use

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. in the full CMI.

3. What if I am taking other medicines?

When some medicines are taken when oxygen is used there may be serious side effects. A list of these medicines is in Section 3. in the full CMI.

4. How do I use Aeris Medical Medical Oxygen?

You will receive Medical Oxygen via a mask or nasal prongs (tubes). Your doctor will decide how much you can have
You can use nasal sprays containing saline, or a water-based lubricant to help prevent getting a stuffy, bleeding or dry nose

More instructions can be found in Section 4. in the full CMI.

5. What should I know while using Aeris Medical Medical Oxygen?

Things you should do	Remind any doctor or pharmacist you visit that you are using this. Make sure the cylinder is secured so that it does not fall over.
Things you must not do	Do not smoke Do not use any oil-based products on the connections or mask. Do not use near open flames, sparks or strong heat.
Looking after your medicine	Store below 30 degrees C. Take care when handling the cylinder and attachments.

For more information, see Section 5. in the full CMI.

6. Are there any side effects?

People may get a dry mouth, throat or nose, bleeding nose, dry cough, tight chest, runny nose or watery eyes. For a list of more serious side effects, and for information about what to do if you get them, see Section 6.

FULL CMI

Aeris Medical Medical E.P. Grade Compressed Oxygen

Active ingredient: Oxygen

Consumer Medicine Information (CMI)

WARNING: OXYGEN AIDS AND INCREASES COMBUSTION (including some materials which do not normally burn in air). Do not smoke when using Medical Oxygen and avoid open flames.

Oxygen can also catch fire if it comes into contact with oils, greases and tarry substances.

This leaflet provides important information about using Aeris Medical Medical Oxygen.

Speak to your doctor, nurse or pharmacist if you want more information, if you are worried or have questions about using Medical Oxygen.

Where to find information in this leaflet:

1. Why am I using Aeris Medical Medical Oxygen?
2. What should I know before I use Aeris Medical Medical Oxygen?
3. What if I am taking other medicines?
4. How do I use Aeris Medical Medical Oxygen?
5. What should I know while using Aeris Medical Medical Oxygen?
6. Are there any side effects?
7. Product details

1. Why am I using Aeris Medical Medical Oxygen?

Aeris Medical Medical Oxygen contains the active ingredient oxygen. It is a medical gas.

Medical Oxygen is used to supply oxygen to the lungs and to help breathing where not enough oxygen is getting to the lungs.

2. What should I know before I use Aeris Medical Medical Oxygen?

Warnings

Do not use Medical Oxygen if:

You smoke and intend to keep smoking.
You have trouble breathing but it is not due to a lack of oxygen in the lungs

Check with your doctor if you:

Have any other medical conditions
Take any medicines for any other condition

Only use it if your doctor has said it is OK.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to watch for them. See extra information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

You will be given the lowest amount of Medical Oxygen for the shortest time.

Elderly people

Older people may need less oxygen

Babies

Newborns, especially premature babies, will be closely monitored by medical staff

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines.

Some medicines may interfere with Medical Oxygen and affect how it works.

If you are taking bleomycin (for cancer)

You may need less oxygen and your fluid levels will be closely monitored, especially if you are having an operation

If you are taking amiodarone (for heart problems)

You will be closely monitored, especially if you are having an operation

Check with your doctor or pharmacist if you are not sure about whether any medicines, vitamins or supplements you are taking may affect you when you are using Medical Oxygen.

4. How do I use Aeris Medical Medical Oxygen?

How much to use

Your doctor will decide how much you can have. The concentration of Oxygen is normally between 21% and 100%.
Follow the instructions provided and use Medical Oxygen until your doctor tells you to stop.

How to use Aeris Medical Medical Oxygen

You will have help in setting up the gas cylinder for use - follow carefully the instructions you are given
The cylinder must be handled carefully with suitable equipment and should not be knocked or allowed to fall
People nearby must not smoke when it is being used
Do not touch any part of the cylinder or equipment with oils or grease, and make sure your hands are clean and free from oils and grease
Avoid using oil based moisturisers or creams on your face or nose when using Medical Oxygen
If you are using Medical Oxygen for longer than an hour, use a water based lubricant or saline nasal spray to prevent getting a dry, stuffy or bleeding nose.

If you have had too much Medical Oxygen

If you think that you have used too much Medical Oxygen, you may need urgent medical attention. This would be the case if you suddenly get a dry cough, pain when breathing, and/or a tight chest, or if you feel dizzy, have fits or pass out.

You must immediately:

Contact your doctor or nurse or pharmacist, or
Go to the Emergency Department at your nearest hospital, or
Phone the Poisons Information Centre
(by calling 13 11 26)

5. What should I know while using Aeris Medical Medical Oxygen?

Things you should do

Call your doctor straight away if you:

Feel that you are not receiving enough oxygen

Remind any doctor, dentist nurse or pharmacist you visit that you are using Medical Oxygen.

Things you must not do

Never smoke or stand near open flames while using medical oxygen
Do not use this product if the cylinder is damaged or the tamper evident seal has been removed

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Medical Oxygen affects you.

Medical Oxygen may cause affect alertness in some people.

Your doctor will assess you and decide whether you can drive or operate machines while using Medical Oxygen.

Looking after your medicine

Store below 30 degrees Celsius (in a cool, dry place)
Make sure that nearby there are no open flames or open lights, no strong heat or nothing that generates sparks
Make sure the cylinder is secured upright so that it won't fall over

Follow the instructions carefully.

Keep it where young children cannot reach it.

Getting rid of any unwanted medical oxygen

If you no longer need to use this, the cylinder is empty or it is out of date, first close the cylinder valve (using moderate force only), release the pressure and put on the valve regulator cap (if there is one fitted).

Ask your supplier (hospital or pharmacy) to collect it from you.

Do not keep the cylinder after its expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Read the following information and, if you need to, ask your doctor or pharmacist if you have any questions about side effects.

Less serious side effects

Less serious side effects	What to do
Runny nose or watery eyes Dry mouth, throat or nose Bleeding nose Dry cough Tight chest	Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects

Serious side effects	What to do
Feeling very dizzy or sick Pain or problems when breathing, collapsed lung Pain, burning or tightness in the chest or throat Racing or irregular heartbeat, cold sweats, turning blue, feeling weak or faint Problems seeing, pain in the ears or problems hearing Trouble thinking clearly, sudden headache, change in mood, twitching, uncontrolled shaking (fits) or loss of consciousness	Call the doctor or nurse straight away if you are already in hospital, otherwise go straight to the Emergency Department at your nearest hospital.

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects that you have had, you can report these side effects to the Therapeutic Goods Administration online atwww.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor nurse or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is normally supplied for use in hospitals or delivered to your home for use there.

What Aeris Medical Medical Oxygen contains

Active ingredient

Oxygen gas

What Aeris Medical Medical Oxygen looks like

Aeris Medical Medical Oxygen has no smell and it is colourless.

The cylinders have a white body, white shoulders and white dome. They are sealed with a Pin Index valve outlet.

They may be available in the following pack sizes:

Container Size	Water capacity (L)	Pressure Barg at 15°	Content m³
B	1.7 Litres	155	0.275m³
BR	1.7 Litres	155	0.275m³
C	2.8 Litres	155	0.470m³
CR	2.0 Litres	200	0.410m³
CXR	3.0 Litres	200	0.620m³
CL	4.6 Litres	155	0.760m³
D	10 Litres	166	1.700m³
DR	10 Litres	166	1.700m³
DF	8.5 Litres	200	1.800m³
E	23 Litres	166	4.00m³
ER	23 Litres	166	4.00m³
G	50 Litres	200	10.3m³
6 pk	300 Litres	200	61.8m³
12 pk	600 Litres	200	123.6m³

Note: 1 Barg = 0.1 Megapascal (MPa); 1 m³ = 1000 litres (L)
(Not all pack sizes may be available)
Aust R 135847.

Who distributes Aeris Medical Medical Oxygen

Supagas Pty Ltd
23 Commercial Drive
Dandenong South
VIC 3175
www.supagas.com.au

This leaflet was prepared in October 2020.

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Aeris Medical E.P. Grade Compressed Oxygen

Active ingredient

Oxygen

Schedule

Unscheduled

1 Name of Medicine

Oxygen.

2 Qualitative and Quantitative Composition

Each gas cylinder contains oxygen 100% v/v.

3 Pharmaceutical Form

Medicinal gas.
Odourless, colourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

Oxygen for medical use.
To increase supply of oxygen to the lungs.
For respiratory support where there is a requirement for medical oxygen to treat or prevent hypoxemia.

4.2 Dose and Method of Administration

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 by-pass system.

Dosage.

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. Nasal symptoms, such as nasal stuffiness, dryness or bleeding may be alleviated by the use of nasal saline sprays or water-based lubricant.
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 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%, by adjusting the oxygen fraction in the inhaled air (FiO₂). The dose (FiO₂) must be adjusted according to each patient's 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 at commencement, with incremental increases based on individual clinical assessment.
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.
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.

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.
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 moisturizing 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.
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 supplier.

4.3 Contraindications

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).
Domiciliary oxygen should generally not be used by patients who continue to smoke cigarettes, due to the increased risk of fire. See Section 4.4 Special Warnings and Precautions for Use.

4.4 Special Warnings and Precautions for Use

General.

Warning: oxygen aids and increases combustion. Oxygen strongly supports combustion. Smoking is prohibited and no naked flame is allowed.
Oxygen when in contact with oils, greases, tarry substances and many plastics is highly dangerous due to the risk of spontaneous combustion with high-pressure gases.
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, 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.

The normal precautions required for the storage and use of medical gas cylinders are applicable. Because the contents are under pressure and are sometimes hazardous, there are special safety regulations for handling cylinders of gases. These include chaining cylinders 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; Section 6.4 Special Precautions for Storage.
Additional information is contained in the safety data sheet 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 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. 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 arterial blood gas measurements, or arterial oxygen saturations via pulse oximetry, as clinically appropriate.

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 require 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.

Effects on laboratory tests.

None stated.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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 postoperative 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)
When oxygen is used in pregnancy as clinically required, to treat intercurrent illness and avoid hypoxia, at the lowest concentration for the shortest possible time.
Hyperbaric oxygen treatment during gestation in mice, rats, hamsters and rabbits led 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.
Oxygen is used during breast-feeding as clinically required, to treat intercurrent illness and avoid hypoxia, at the lowest concentration 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 require oxygen support will require individual assessment as to their ability to drive or to operate machinery. Oxygen therapy may affect the level of consciousness in a patient with hypercapnia and reduced respiratory drive. (See Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

Oxygen toxicity depends upon both the inspired partial pressure of oxygen (a function of concentration and barometric pressure) and duration of exposure, the safe duration decreasing as pressure increases.
With 100% normobaric oxygen, symptoms of pulmonary toxicity are cough, substernal chest pain, mild dyspnoea, malaise, nausea, or transient parasthesiae 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 central nervous system toxicity (CNS); 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:

Blood and lymphatic system disorders.

Haemolysis of red blood cells.

Ear and labyrinth disorders.

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

Eye disorders.

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

Gastrointestinal disorders.

Nausea.

General disorders and administration site conditions.

Lipid peroxidation and cell membrane damage due to chemical toxicity in any metabolising cells.

Nervous system 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 thoracic and mediastinal disorders.

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 have been reported with hyperbaric oxygen.

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

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 131126 (Australia).

5 Pharmacological Properties

Pharmacotherapeutic group: GASMED, gas, medical. ATC code: V03AN01.

5.1 Pharmacodynamic Properties

Mechanism of action.

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).
The basal oxygen consumption in humans is approximately 250 mL/min for a body surface of 1.8 square metres. In anaesthesia and natural sleep it is reduced by about 10% and decreased by about 50% for a 10°C fall in body temperature.
Alveolar air contains about 14% oxygen at 14 kPa (105 mmHg) and the arterial blood has an oxygen tension of 13 kPa (97 mmHg). The difference (the alveolar-arterial oxygen tension gradient), increases with age, and may be as great as 4 kPa (30 mmHg) in a healthy, elderly individual.
Oxygen in the blood is mostly combined with haemoglobin. Normally haemoglobin in arterial blood is 97% saturated and the oxygen content of the blood is 19.8 vol %, 0.3 mL of this being carried in solution. The remainder is bound to haemoglobin.
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 4 minutes supply of oxygen circulating in the blood.

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.

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 5 kPa (40 mmHg) and 2 kPa (15 mmHg), the oxygen carried in the blood from the lungs can be readily given up to the tissues. See Figure 1.

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.

5.3 Preclinical Safety Data

Genotoxicity.

Genotoxicity studies (in vitro and in vivo) have shown that hyperbaric oxygen causes DNA damage and chromosomal aberrations. However, the risk of damage to genetic material from intermittent exposures to normobaric oxygen is considered to be low.

Carcinogenicity.

There are no carcinogenicity studies with oxygen, but carcinogenic risk from intermittent exposures to normobaric oxygen is likely to be low.

6 Pharmaceutical Particulars

6.1 List of Excipients

Not 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. See Section 4.4 Special Warnings and Precautions for Use.

6.5 Nature and Contents of Container

Aluminium alloy (C or CR wound with carbon fibre) or steel (D, E and G) gas cylinder with brass valve closure. The BR, 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

Aeris compressed medical gas 100% v/v oxygen E.P. grade complies with current European Pharmacopoeial specifications:
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.
Appearance: odourless, colourless gas.
Vapour density: 1.105 @ 25°C.
Boiling point: -183°C.
Combustion characteristics: non-flammable. Strongly supports combustion.

Chemical structure.

Molecular formula: O₂.

CAS number.

7782-44-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

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Aeris Medical E.P. Grade Compressed Oxygen

Oxygen

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