COREGAS Pty Ltd MEDICAL OXYGEN 100%v/v gas in gas cylinder Medicinal Gas

MIMS Revision Date: 01 May 2022

1 Name of Medicine

Oxygen.

2 Qualitative and Quantitative Composition

Oxygen 100%.

3 Pharmaceutical Form

Medical gas.
Colourless, odourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

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.
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 patients with chronic respiratory disorders with hypercapnia, there is a risk of reduced respiratory drive with high oxygen concentrations.
Oxygen treatment must be continuously evaluated.
Coregas Pty Ltd Medical Oxygen 100% should not be used for hyperbaric oxygen treatment.
Use in adults and children. For respiratory use at concentrations of greater than 21%.
Use in neonates. 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.
When administering oxygen to neonates the inspired concentration of oxygen should not exceed 40% (see Section 4.8 Adverse Effects (Undesirable Effects)).
Use in the elderly. When giving oxygen to elderly chronic bronchitis patients the inspired concentration of oxygen should only be raised by 1% increments and should not exceed 30%.
Instructions for use/handling. Care is needed in the handling and use of medical oxygen gas cylinders.
Refer to the respective S.D.S and the "caution" section of the product label. Refer to manufacturer for cleaning guidelines.
For liquid medical oxygen, the extreme cold can lead to "cold burns"/ destruction of tissue.
Preparation for use with pin index valves. 1. Cylinder valves should be opened momentarily prior to use to blow any foreign matter out of the outlet.
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. Cylinder valves must be opened slowly.
4. Only the appropriate regulator should be used for the particular gas concerned.
5. Cylinder valves and any associated equipment must never be lubricated and must be kept free from oil and grease.
Preparation for use with integrated regulator valves. 1. Connect oxygen tubing to "fir tree" outlet on top of the integrated regulator valve.
2. Connect oxygen equipment to sleeve index on the side of the integrated valve regulator.
3. Open the integrated regulator valve slowly.
4. Select desired flow rate on top of integrated regulator valve.
Leaks. 1. Should leaks occur this will usually be evident by a hissing noise.
2. Leaks can be found by brushing the suspected area with an approved leak test solution.
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 appropriately and return them to Coregas for repair.
4. Sealing or jointing compounds must never be used to cure a leak.
5. Never use excessive force when connecting equipment to cylinders.
Handling of cylinders. 1. Cylinders should be handled with care and not knocked violently or allowed to fall.
2. Cylinders should only be moved with the appropriate size and type of trolley.
3. When in use cylinders should be firmly secured to a suitable cylinder support.
4. Cylinders containing liquefiable gas must always be used vertically with the valve uppermost.
5. Medical gases must only be used for medicinal purposes.
6. Smoking and naked lights must not be allowed within the vicinity of cylinders or pipeline outlets.
7. After use cylinder valves should be closed using moderate force only and the pressure in the regulator or tailpipe released.
8. When empty, the cylinder valve must be closed.
9. Immediately return empty cylinders to the empty cylinder store for return to Coregas.

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

Liquid oxygen can lead to severe "cold burns" or destruction of tissue.
Use of gas cylinders. 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).
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 Material Safety Data Sheet for Coregas Pty Ltd Medical Oxygen from Coregas Pty Ltd.
Administration of oxygen. 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.)
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.
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, as clinically appropriate.
Use in the elderly. Use in the elderly is determined by clinical assessment and course of the illness. 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 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, with use of low concentrations, 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. Not applicable.
Use in pregnancy. (Category A)
Oxygen does not adversely affect pregnancy.
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.
Pregnant women should not be exposed to hyperbaric oxygen.
Use in lactation. Oxygen does not adversely affect lactation, when used at the lowest concentration for the shortest amount of time.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. 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. Symptoms of pulmonary toxicity are cough, substernal chest pain, mild dyspnoea, malaise, nausea, or transient paresthesia, substernal distress, atelectasis, decrease in vital capacity and acute respiratory distress syndrome. 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. Retinopathy of prematurity, tunnel vision, myopia with hyperbaric oxygen.
Retrolental fibroplasia may occur in premature infants exposed to oxygen at concentrations greater than 40%.
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.
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.
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.
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.
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

Symptoms. 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)).
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.
Treatment. The mainstay of treatment is supportive and symptomatic care.
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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. None stated.
Clinical trials. Not applicable.

5.2 Pharmacokinetic Properties

Absorption. The uptake of oxygen by the blood in the lungs and discharge to the tissues is determined by the oxygen dissociation curve.
Distribution. The characteristic sigmoid shape 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.
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

Genotoxicity. Not applicable.
Carcinogenicity. Not applicable.

6 Pharmaceutical Particulars

6.1 List of Excipients

None stated.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Shelf life is according to appropriate Australian Standards.

6.4 Special Precautions for Storage

Storage. Storage is according to the appropriate Australian Standards.
Cylinders should be kept out of the reach of children.
Oxygen is enhancing combustion (including some materials which do not normally burn in air). High pressure oxygen can lead to oxidation/ fire/ explosion when getting in contact with oils, greases, tarry substances and many plastics (spontaneous combustion).
The normal precautions required in the storage of medical gas cylinders as described below are applicable.
Cylinders should be stored under cover in a well-ventilated area, 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 empty cylinders should be stored separately. Full cylinders should be used in strict rotation so that cylinders with the earliest filling date are used first.
Cylinders must not be repainted, have any markings obscured or labels removed.
D size cylinders and larger should be stored vertically. C size cylinders can be stored horizontally.
Precautions should be taken to protect cylinders from theft.
In addition to the above, for liquid oxygen:
Personal protective equipment in the form of a face shield, long shirts/ trousers or overalls, isolated gauntlets and safety boots must be worn.
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 4.2 Dose and Method of Administration. Consult the information provided by Coregas Pty Ltd 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 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.
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.

6.5 Nature and Contents of Container

Gaseous medical oxygen is supplied in gas cylinders with a pin index valve suitable for the filling pressure applied for the product. Size C, D and E cylinders may also be supplied with an alternative integrated regulator valve.
The cylinders for gaseous medical oxygen may be constructed of either steel or aluminium.
Liquid medical oxygen (cryogenic liquid), is supplied for storage and transport purposes in bulk containers: - flasks, tanks/tankers/seatainers.
The flasks, tanks/tankers/seatainers used for liquid medical oxygen are made of steel and are vacuum insulated suitable for the cryogenic nature of the content and fitted with withdrawal valves.
The types of cylinders normally used are specified in Table 1 (note: water capacity is nominal):

Medical oxygen AUST R. 34472.
Medical oxygen (liquid) AUST R. 199515.

6.6 Special Precautions for Disposal

Immediately return empty cylinders to the empty cylinder store for return to Coregas.

6.7 Physicochemical Properties

Oxygen is a colourless, odourless gas with a boiling point of -183.1°C (at 101.325 kPa) and a density of 1.355 kg/m³ (at 15°C and 101.325 kPa).
Oxygen is present in the atmosphere at 21% and is an absolute necessity for life.
Chemical structure. O = O.
CAS number. 7782-44-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Date of Revision

22 March 2022

Summary Table of Changes