SUMMARY CMI

CARBANOX (Medical Carbon Dioxide 5% and Oxygen 95% v/v gas) in gas cylinder Medicinal Gas

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using Carbanox, speak to your healthcare professional.

1. Why am I having Carbanox?

Carbanox contains the active ingredients Carbon Dioxide and Oxygen.

It is used in babies, children and adults to stimulate breathing, or as an anaesthetic supplement or during medical investigations. For more information, see Section 1. in the full CMI.

2. What should I know before I have Carbanox?

You will only have this if your healthcare professional has said it is OK for you to use it.

Tell them if you:

• Have any other medical conditions, especially acidosis or long-term breathing disorders
• Take any medicines for any other condition, or any other drugs
• Are pregnant, planning to become pregnant, or are breastfeeding or plan to breastfeed.

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

3. What if I am taking other medicines?

Tell the person treating you if you are taking any other medicines, especially adrenaline-like medicines or medicines for treating blood pressure. Also tell them if you are taking vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. See Section 3. in the full CMI.

4. How do I have Carbanox?

You will receive Carbanox via a mask or tubes. Your healthcare professional will decide how much you can have. More information can be found in Section 4. in the full CMI.

5. What should I know while having Carbanox?

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

6. Are there any side effects?

A small number of people may experience sweating, nausea and headache while having Carbanox.

For information about what to do if you get any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CARBANOX (Medical Carbon Dioxide 5% and Oxygen 95% v/v gas) in gas cylinder Medicinal Gas

Active ingredients: Carbon dioxide and oxygen

Consumer Medicine Information (CMI)

This leaflet provides important information about using Carbanox.

Speak to your healthcare professional if you want more information, if you are worried or if you have questions about using Carbanox.

Where to find information in this leaflet:

1. Why am I having Carbanox?
2. What should I know before I have Carbanox?
3. What if I am taking other medicines?
4. How do I have Carbanox?
5. What should I know while having Carbanox?
6. Are there any side effects?
7. Product details
For the Healthcare Professional

1. Why am I having Carbanox?

Carbanox contains the active medical ingredients carbon dioxide (5%v/v) and oxygen (95% v/v). It is a medical gas.

It is used in babies, children and adults to stimulate breathing, or as an anaesthetic supplement or during medical investigations.

2. What should I know before I have Carbanox?

Tell the person treating you if you:

• Have any other medical conditions, especially acidosis or long-term breathing disorders
• Take any medicines for any other condition
• Have taken too much of a medicine or drug
• Are pregnant, planning to become pregnant, or are breastfeeding or plan to breastfeed.

You will only have this if your healthcare professional has said it is OK.

Pregnancy and breastfeeding

Carbanox is not recommended for use during pregnancy, but it is unlikely to affect breastfeeding.

Tell the person treating you if:

• you are pregnant or planning to become pregnant
  or
• you are breastfeeding or planning to breastfeed.

Elderly people

• Carbanox may be used in elderly people and they will be monitored during treatment.

Children and Babies

• Carbanox may be used in babies and children and they will be monitored during treatment. Newborn babies will receive a smaller dose of the gas.

3. What if I am taking other medicines?

Tell the person treating you if you are taking any other medicines, especially adrenaline-like medicines or medicines for treating blood pressure. Also tell them if you are taking vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

4. How do I have Carbanox?

How much to have

Your healthcare professional will decide how much to have.

Follow their instructions and use Carbanox until you are told to stop. They will monitor you or your child's treatment and change the amount if needed.

How you will have Carbanox

You will receive Carbanox via a mask or tubes. It is normally given to you by a healthcare professional.

• The gas cylinder will be set up for you - follow carefully any instructions you are given

If you have had too much Carbanox

It is unlikely that you can have too much Carbanox by itself, however if after treatment you feel very unwell, then:

You must immediately:

• Tell the person treating you, 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 having Carbanox?

Things you should do

Tell your healthcare professional or emergency services officer straight away if you:

• Feel that you are not receiving enough Carbanox
• Hear a hissing sound coming from the cylinder
• Feel unwell

Things you must not do

• Never smoke or stand near open flames, sparks or high heat while having Medical Carbanox (which contains oxygen)
• Do not use this product if the reason you are unable to breathe is because you have taken a certain drug
• Do not touch any part of the cylinder or equipment with oils or grease, and make sure your skin is clean and free from oils and grease (this includes not using oil-based moisturisers or creams on your face or nose.
• This cylinder will not be used if it is damaged or the tamper evident seal has been removed.

Driving or using machines

While Carbanox itself is unlikely to affect you, any medical treatment you had or other medicines/gases you were given, may affect you. Your doctor will assess you and decide whether you can drive or operate machines. Nevertheless, you must not drive while receiving Carbanox.

Drinking alcohol

Tell your healthcare professional or emergency services officer if you have recently drunk alcohol. It is inadvisable to drink alcohol while having treatment with Carbanox.

Looking after your medicine

• Make sure that it is not near any other gas cylinders or anything that may burn (including oils, greases, tars and plastics)
• Make sure that there are no open flames or open lights nearby, no strong heat or anything that gives off sparks
• Check that the cylinder is secured so that it won't fall over.

Keep it where children cannot see or reach it.

Getting rid of any unwanted Carbanox

The cylinder will be returned to Coregas.

Do not keep the cylinder after its expiry date.

6. Are there any side effects?

A small number of people may experience sweating, nausea and headache while having Carbanox.

You may be given other gases or medicines as well, so read the CMI for these also.

Tell the person treating you if you feel unwell in any way.

Reporting side effects

After you have received medical advice for any side effects you may have had, you can report these side effects to the Therapeutic Goods Administration online at www.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 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 in emergency situations.

What Carbanox contains

What Carbanox looks like

Carbanox has no smell or colour.

The cylinders have a white body with green-grey and white quadrants on the shoulder. They are made of either steel or aluminium and sealed with a Pin Index valve outlet.

They may be available in the following pack sizes:

(Not all pack sizes or presentations may be available)

Who distributes Carbanox?

Coregas Pty Ltd
66 Loftus Road
Yennora NSW 2161
Australia

Email: [email protected]
Phone: 1800807203
Website: www.coregas.com.au/healthcare

Aust R 27180.

This leaflet was revised in April 2023.

For the Healthcare Professional

Instructions for use/handling

• Care is needed in the handling and use of Carbanox gas cylinders
• Medical gases must only be used for medicinal purposes
• Refer to the respective S.D.S and the “caution” section of the product label.
• Refer to manufacturer for cleaning guidelines.
• Cylinders should be handled with care and not knocked violently or allowed to fall.
• Cylinders should only be moved with the appropriate size and type of trolley.
• When in use cylinders should be firmly secured to suitable cylinder support.
• Cylinders containing liquefiable gas must always be used vertically with the valve uppermost.
• Smoking and naked lights must not be allowed within the vicinity of cylinders or pipeline outlets.
• After use cylinder valves should be closed using moderate force only and the pressure in the regulator or tailpipe released.
• When empty the cylinder valve must be closed.
• Immediately return used cylinders to the used cylinder store for return to Coregas.

Preparation for use

• Cylinder valves should be opened momentarily prior to use to blow any foreign matter out of the outlet.
• 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.
• Cylinder valves must be opened slowly.
• Only the appropriate regulator should be used for the particular gas concerned.
• Cylinder valves and any associated equipment must never be lubricated and must be kept free from oil and grease

Leaks

• Should leaks occur, this will usually be evident by a hissing noise.
• Leaks can be found by brushing the suspected area with an approved leak test solution.
• There are no user serviceable parts associated with the valves fitted, so 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.
• Sealing or jointing compounds must never be used to cure a leak.
• Never use excessive force when connecting equipment to cylinders.

Storing of cylinders

Carbanox cylinders should be kept out of the reach of children.

Carbanox enhances combustion.

The normal precautions required in the storage of medical gas cylinders as described below are applicable.

• Cylinders should be stored under cover, preferably inside, kept dry and clean and not subjected to extremes of heat or cold.
• Cylinders should not be stored near stocks of combustible materials or near sources of heat.
• Warning notices prohibiting smoking and naked lights must be posted clearly.
• Emergency services should be advised of the location of the cylinder store.
• Medical cylinders containing different gases should be segregated and identified within the store.
• Full and empty cylinders should be stored separately. Full cylinders should be used in strict rotation.
• Cylinders must not be re-painted, 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.

This leaflet was revised in April 2023

Published by MIMS July 2023

1 Name of Medicine

Carbon dioxide and oxygen.

2 Qualitative and Quantitative Composition

Carbon dioxide 5% v/v and oxygen 95% v/v.

3 Pharmaceutical Form

Medicinal gas.
Colourless, odourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

As a respiratory stimulant after apnoea or after chronic respiratory obstruction has been relieved.
In clinical situations where carbon dioxide is needed as an anaesthetic supplement.
Use in clinical and physiological investigations.

4.2 Dose and Method of Administration

Use in adults, the elderly and children.

For use in neonates.

Instruction for use/ handling.

Preparation for use.

Leaks.

Handling of cylinders.

4.3 Contraindications

The gas mixture is contraindicated in acidosis, chronic respiratory disease and patients with drug-induced respiratory depression.

4.4 Special Warnings and Precautions for Use

Oxygen supports combustion and smoking should be prohibited when this gas mixture of carbon dioxide 5% and oxygen 95% is in use.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Carbon dioxide 5%/ oxygen 95% interacts with anaesthetic agents when the carbon dioxide concentration is raised and gives rise to cardiac dysrhythmias. The onset of these symptoms varies with the type of anaesthetic. The mixture also interacts with adrenergic substances (e.g. adrenaline). Adrenergic substances should not be used at the same time as carbon dioxide 5%/ oxygen 95%.
Carbon dioxide 5%/ oxygen 95%, by altering pH, influences uptake distribution and action of many drugs including neuromuscular blocking agents, and hypotensive agents. Care should be taken when administering drug substances at the same time as carbon dioxide 5%/ oxygen 95%.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The inhalation of carbon dioxide 5%/ oxygen 95% is not compatible with driving vehicles or the operating of machinery.

4.8 Adverse Effects (Undesirable Effects)

Use of the gas mixture may result in sweating, nausea and headache in a small number of patients.

Reporting suspected adverse effects.

4.9 Overdose

Not applicable.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

The effect of inhaling carbon dioxide, or of its accumulation in the body through breathing defects, varies with the tension achieved in the blood, the duration and condition of the exposure and the susceptibility of the individual concerned.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

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 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.

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 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

Cylinders should be kept out of the reach of children.
Medical Carbanox enhances combustion.
The normal precautions required in the storage of medical gas cylinders as described below are applicable.
Cylinders should be stored under cover, preferably inside, kept dry and clean and not subjected to extremes of heat or cold.
Cylinders should not be stored near stocks of combustible materials or near sources of heat.
Warning notices prohibiting smoking and naked lights must be posted clearly.
Emergency services should be advised of the location of the cylinder store.
Medical cylinders containing different gases should be segregated and identified within the store.
Full and empty cylinders should be stored separately. Full cylinders should be used in strict rotation.
Cylinders must not be repainted, have any markings obscured or labels removed.
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.

6.5 Nature and Contents of Container

Medical Carbanox is supplied in aluminium or steel gas cylinders with a PIN index valve, suitable for the filling pressure applied for the product.
The types of cylinders normally used are specified in Table 1.

Notes.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Carbon dioxide is a colourless, odourless gas with a sublimation point of -78.5°C (at 101.325 kPa), a density of 1.872 kg/m³ (at 15°C and 101.325 kPa) and a specific gravity of 1.53 (at 15°C and 101.325 kPa).
Carbon dioxide occurs at approximately 350 ppm v/v in the atmosphere.
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.
Medical Carbanox, a 5% carbon dioxide/ 95% oxygen medical gas mixture, has a specific gravity of 1.13 (at 15°C and 101.325 kPa) and a density of 1.38 kg/m³ (at 15°C and 101.325 kPa).

Chemical structure.

CAS number.

Carbon dioxide.

Oxygen.

Molecular weight.

Carbon dioxide.

Oxygen.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes