Consumer medicine information

Medical Carbon Dioxide

Carbon dioxide

BRAND INFORMATION

Brand name

Coregas Medical Carbon Dioxide

Active ingredient

Carbon dioxide

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Medical Carbon Dioxide.

What is in this leaflet

Please read this leaflet carefully before you receive this treatment. It provides a summary of the information known about your treatment. If you have any questions or are unsure about anything, ask your doctor.

Remember, this treatment is for you. It may harm someone else if they receive it even if their symptoms appear to be the same as yours. So do not give this treatment to anybody else. Keep this leaflet. You may wish to refer to it again.

What Medical Carbon Dioxide is used for

Medical Carbon Dioxide is used with anaesthetics. This is to make sure your blood levels of Carbon Dioxide are satisfactory so that you breathe easily during surgery. Medical Carbon Dioxide also makes you breathe in deeply so that the anaesthetic is rapidly effective and stays effective throughout the surgery.

Medical Carbon Dioxide can be used to stimulate your breathing if you stop breathing or if your breathing has been obstructed in some way, but is now cleared. Medical Carbon Dioxide can also be used to calm your breathing if you are over-breathing (hyperventilation).

Medical Carbon Dioxide may sometimes be used in clinical investigations including procedures to expand an organ inside your body so that it can be examined internally.

Before you take Medical Carbon Dioxide

If you are not sure if you should be taking Medical Carbon Dioxide, talk to your doctor.

Tell your doctor if:

You are pregnant or plan to become pregnant.

You are breast feeding or plan to breast feed.

If you cannot breathe properly because your airways are blocked, if you are being resuscitated, if your body fluids are abnormally acidic or if you are pregnant you should not use Medical Carbon Dioxide. Please consult your doctor.

High levels of Medical Carbon Dioxide breathed in can interact with anaesthetics and cause abnormal heart rhythms.

Medical Carbon Dioxide also interacts with adrenergic substances such as adrenaline and can affect how you absorb many drugs into your body including drugs to control your blood pressure and drugs affecting nerve signal transmission in your body (neuromuscular blocking agents). Please tell your doctor about any medicines you are taking before starting Medical Carbon Dioxide treatment.

You should not drive or operate machinery while taking Medical Carbon Dioxide.

How to take Medical Carbon Dioxide

Your doctor or nurse will decide how much Medical Carbon Dioxide you need. You will usually breathe the gas in via a face mask. You should only breathe in 5% or less Medical Carbon Dioxide (except for certain clinical investigations). For expanding organs of the body 100% Medical Carbon Dioxide may be used.

What to do if you take too much

If you breathe in too much Medical Carbon Dioxide (more than 6%) you will suffer from headaches, confusion, high blood pressure, irregular heartbeat, rapid and heavy breathing. At higher levels of Medical Carbon Dioxide (more than 810%) you will be dizzy and become unconscious. At very high levels (more than 30%) in addition to unconsciousness, you will have extremely high blood pressure, very low heart rate and ECG changes. Convulsions may also occur. When you stop breathing in Medical Carbon Dioxide, all these effects are reversed.

While you are taking Medical Carbon Dioxide

If you take 5% Medical Carbon Dioxide, your breathing will become more rapid and you will breathe more deeply. Your skin will become pink and warm. You may sweat and feel uncomfortable. After taking Medical Carbon Dioxide for a long time, when you start breathing air again you may feel tired, develop a headache, go pale and feel sick or vomit.

Some patients undergoing laparoscopy, where Medical Carbon Dioxide is used to expand the organs, sometimes have abnormal heart rhythms. Heart failure due to gas bubbles in the blood has been reported.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

After using Medical Carbon Dioxide

Storage

Medical Carbon Dioxide is supplied to the hospital or clinic or doctor and they will be responsible for ensuring the container is stored in accordance with the manufacturer’s instructions.

Disposal

Medical Carbon Dioxide is supplied to the hospital or clinic or doctor and they will be responsible for ensuring the container is returned to the manufacturer.

Product Description

What it looks like

Medical Carbon Dioxide is a colourless, odourless gas supplied in a pressurised gas cylinder with a valve. The gas cylinder contains only Medical Carbon Dioxide.

The gas cylinders’ colour code is a white body with a green grey shoulder (plus 2 x “N”), as determined by AS 4484.

Cylinder sizes include 2.8L, 9.5L, 23L and 50L, as measured by nominal water capacity.

Ingredients

Active
Carbon Dioxide 100% v/v.

Manufacturer/Distributor/ Supplier:

Coregas Pty. Ltd.
66 Loftus Road.
Yennora. NSW. 2161
Australia

AUST R 27190

This leaflet was prepared in June 2013.


Published by MIMS September 2019

BRAND INFORMATION

Brand name

Coregas Medical Carbon Dioxide

Active ingredient

Carbon dioxide

Schedule

Unscheduled

 

1 Name of Medicine

Carbon dioxide.

2 Qualitative and Quantitative Composition

Carbon dioxide 100% v/v.

3 Pharmaceutical Form

Medicinal gas.
Colourless, odourless gas.

4 Clinical Particulars

4.1 Therapeutic Indications

As an anaesthetic supplement in various clinical circumstances to maintain optimum blood carbon dioxide levels, facilitate blind intubation and rapidly increase depth of anaesthesia with volatile agents.
As a respiratory stimulant after apnoea or after relief of chronic respiratory obstruction.
To prevent hypocapnia during hyperventilation.
Use in clinical and physiological investigations including use as insufflation gas.

4.2 Dose and Method of Administration

Use in adults, the elderly and children.

For respiratory use at concentrations of 5% or less, except for certain investigations where concentration may exceed 5%. Also 100% carbon dioxide may be used for insufflation.

Instruction for use/handling.

Care is needed in the handling and use of Medical Carbon Dioxide gas cylinders. Refer to the respective S.D.S and the "caution" section of the product label.
Refer to manufacturer for cleaning guidelines.

Preparation for use.

1. 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.
2. Cylinder valves must be opened slowly.
3. Only the appropriate regulator should be used for the particular gas concerned.
4. Cylinder valves and any associated equipment must never be lubricated and must be kept free from oil and grease.

Leaks.

1. Should leaks occur this will usually be evident by a hissing noise.
2. 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.
3. Sealing or jointing compounds must never be used to cure a leak.
4. 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

Carbon dioxide should not be used in acidosis, in respiratory obstruction and during resuscitation.

4.4 Special Warnings and Precautions for Use

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Carbon dioxide interacts with anaesthetic agents when the concentration is raised and gives rise to cardiac dysrhythmias. It also interacts with adrenergic substances (e.g. adrenaline).
Carbon dioxide, by altering pH, influences uptake, distribution and action of many drugs including neuromuscular blocking agents and hypotensive agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Not applicable.
(Category C)
The use of carbon dioxide is not recommended in pregnancy.
Carbon dioxide is unlikely to influence lactation.

4.7 Effects on Ability to Drive and Use Machines

Inhalation of carbon dioxide is not compatible with driving vehicles or the use of machinery.

4.8 Adverse Effects (Undesirable Effects)

If a normal, conscious individual inhales 5% carbon dioxide, the rate and depth of breathing rise and the minute volume increases 2 - 5 fold. The skin becomes pink and warm and there may be sweating and a sense of discomfort. There is no effect on consciousness or mental function, even with long exposures. After a prolonged exposure, when the return to breathing air takes place, an "off effect" may develop with malaise, pallor, headache and occasional nausea and vomiting, probably due to the metabolic disturbance as a result of breathing a volatile acid.
Cardiac dysrhythmias have been reported in patients undergoing laparoscopy as a result of high blood carbon dioxide levels. Cardiac arrest due to gas embolism has been reported.

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

At concentrations of greater than 6%, carbon dioxide causes headaches, mental confusion, palpitations, hypertension, dyspnoea, increased depth and rate of respiration and depression of the central nervous system. At around 8 - 9%, dizziness may develop. At concentrations of 10% and higher, carbon dioxide possesses anaesthetic properties and may cause unconsciousness. Most people will become unconscious at 12.5% and all subjects lose consciousness with 1 - 2 minutes at 20%. When the concentration is raised to 30%, consciousness is lost rapidly, the blood pressure may rise to 27 kPa (200 mmHg) or higher and there is intense vasoconstriction, a reduction in heart rate to 40 - 50 beats per minute and ECG changes. Convulsions may occur. Inhalation of 50% carbon dioxide has been reported to produce central effects similar to anaesthetics. All anaesthetic agents reduce the responses to carbon dioxide.
The effects are reversed when the breathing in of carbon dioxide ceases.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Carbon dioxide is a potent stimulus to respiration. Carbon dioxide has circulatory effects and increases heart rate and cardiac output. Carbon dioxide also causes depression of cerebral cortex activity.
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 (see Section 4.9 Overdose).

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

When inhaled, carbon dioxide is rapidly distributed throughout the body. Physiologically, it regulates the rate and depth of breathing and normally there is constant tension of 5 kPa (40 mmHg) in arterial blood. The concentration of carbon dioxide in the plasma is three times greater than that in red blood cells. The gas is carried partly in solution (2.4 - 2.7 vol. %), but mostly either as bicarbonate (42.9 - 46.7 vol. %), or as carbamino compound (3.0 - 3.7 vol. %). The relative quantities in solution and as bicarbonate regulate the reaction of the blood and buffer changes in pH produced by stronger organic acids.
Carbon dioxide produced by metabolism plays an integral part in the supply of Oxygen to the tissues, since the amount released by haemoglobin at any given oxygen tension is directly related to the carbon dioxide tension in the blood. This in turn is governed by tissue activity and the concentration inhaled. Thus the rate at which oxygen is given up to the tissues is increased when the carbon dioxide tension is raised.
When a patient becomes apnoeic, carbon dioxide produced in the tissues accumulates in the blood at a rate of about 0.7 kPa (5 mmHg) per minute.

5.3 Preclinical Safety Data

Genotoxicity.

Not applicable.

Carcinogenicity.

Not applicable.

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.
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 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.
All cylinders should be stored vertically.
Precautions should be taken to protect cylinders from theft.

6.5 Nature and Contents of Container

Carbon dioxide is supplied in an aluminium or steel gas cylinder 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.

Cylinders conform to AS 2030.1.
Cylinder valves conform to AS 2473.1 and AS 2473.3.
The cylinders are colour coded conforming to AS 4484.
The colour code for medical carbon dioxide is a white body with a green grey shoulder.

6.6 Special Precautions for Disposal

Immediately return empty cylinders to the empty 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 specific gravity of 1.53 (at 15°C and 101.325 kPa) and a density of 1.872 kg/m3 (at 15°C and 101.325 kPa).
Carbon dioxide occurs at approximately 350 ppm v/v in the atmosphere.

Chemical structure.

Molecular formula: CO2.

CAS number.

124-38-9.
Molecular weight: 44.01.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes