Consumer medicine information

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.

All medicines have risks and benefits. Your doctor or healthcare professional has weighed the risks of you using Medical Equanox against the benefits they expect it will have for you.

If you have any concerns about using Medical Equanox , ask your doctor.

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

What Medical Equanox is used for

Medical Equanox is a gas mixture of 50% Medical Nitrous Oxide and 50% Medical Oxygen (nominal) used for pain relief.

Medical Equanox works by relieving pain for certain procedures.

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

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

Before you use Medical Equanox

Do not take Medical Equanox if

1. You have a condition where air is entrapped within your body and it might expand when given nitrous oxide (e.g. bowel obstruction, blocked middle ear, following a recent dive). Ask your doctor for full details of these conditions.
2. You have been using Medical Equanox for a prolonged period without proper monitoring of your blood.
3. You are intoxicated or heavily sedated.

You must tell your doctor if

1. You have had a reaction to Medical Equanox or any other general anaesthetic or pain relief medication in the past.
2. You have had a general anaesthetic.
3. You have or have had any other health problems or medical conditions, including:

• Low vitamin B12 levels.
• Head injuries with impairment of consciousness.
• Artificial, traumatic or spontaneous pneumothorax.
• Air embolism.
• Decompression sickness.
• Following a recent dive.
• Following air encephalography.
• Sever bullous emphysema.
• During myringoplasty.
• Gross abdominal distension.
• Intoxication.
• Maxillofacial injuries.

4. You are pregnant or intend to become pregnant. Pregnant females may experience spontaneous abortion and low birth weight babies.
5. You have had long term usage or been chronically exposed to nitrous oxide.

Taking other medicines

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.

Your doctor may have more information on medicines to avoid while using Medical Equanox.

If you have not told your doctor about any of the above, tell them before you start using Medical Equanox .

How to use Medical Equanox

Medical Equanox 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 Equanox given to you will be decided by your doctor, depending on the amount of pain relief required. It is usually given to you by breathing it through a mask or mouthpiece.

If you are elderly or have lung problems, you may need a lesser amount of Medical Equanox.

Follow all directions given to you by your doctor carefully. These directions may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor for help.

How long to use it

Your doctor will decide for how long you need to use Medical Equanox.

If you use too much (overdose)

As Medical Equanox is most likely to be given to you under the direction of your doctor, anaesthetist, ambulance officer, dentist or nurse, it is very unlikely you will receive an overdose. However, if this happened, quick action can be taken to maintain your breathing and replace the Medical Equanox with oxygen.

If you have any questions, then ask your doctor.

While you are taking Medical Equanox

Things you must do

Tell your doctors, dentists and pharmacists who are treating you that you are taking Medical Equanox.

Tell your doctor if you become pregnant while taking Medical Equanox.

Tell your doctor if you have taken a general anaesthetic.

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

Things you must not do

Do not stop taking Medical Equanox without first checking with your doctor.

Do not drive a vehicle or operate machinery.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are using Medical Equanox.

Medical Equanox may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you experience some of the side effects.

Ask your doctor any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• Nausea, vomiting.
• Headache, dizziness.

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

• Confusion, excitation, depression.
• Breathing problems.
• Heart problems.
• Pins and needles, changes in sensation.
• Bleeding, fits.
• Abdominal pain, bloating.
• Addiction.
• Paraestsiqe in the legs.
• Hyperflexia and weakness of the intrinsic hand muscles.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare. Other side effects may occur as a result of other medications received, so check with your doctor if you have any concerns.

If any of the above happen, 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 Equanox

Storage

Medical Equanox 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 Equanox 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 Equanox is a clear, colourless, slightly sweet smelling, non-irritating gas. supplied in a pressurised gas cylinder with a valve. The gas cylinder contains only Medical Equanox. The gas cylinders’ colour code is a white body with a ultramarine & white triangle shoulder (plus 2 x “N”) as determined by AS4484.

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

Ingredients

Active
Nitrous oxide: 50% v/v /
Oxygen: 50% v/v.

Manufacturer/Distributor/ Supplier:

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

AUST R 27141.

This leaflet was prepared in June 2013.

Published by MIMS November 2019

1 Name of Medicine

Nitrous oxide 50% v/v and oxygen 50% v/v.

2 Qualitative and Quantitative Composition

Nitrous oxide 50% v/v and oxygen 50% v/v.

3 Pharmaceutical Form

Compressed medical gas (for medicinal use only).

4 Clinical Particulars

4.9 Overdose

Symptoms and signs. Inappropriate, unwitting or deliberate inhalation of nitrous oxide will ultimately result in unconsciousness, passing through stages of increasing lightheadedness and intoxication, and, if the victim were to be within a confined space, death from anoxia could result. Other signs may include: bradycardia, respiratory depression, cardiovascular depression and severe hypotension.
Treatment. The treatment is fresh air, mouth-to-mouth resuscitation and, if necessary, the use of an oxygen resuscitator.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. An increased frequency of chromosomal aberrations was observed in bone marrow cells and spermatogonia of rats treated with a mixture of nitrous oxide and halothane. Nitrous oxide also caused an increased incidence of sister chromatid exchanges (SCE) in human lymphocytes in vitro.
Clinical studies have suggested that nitrous oxide may be associated with genotoxic events. DNA strand breaks were reported in surgical patients treated with isoflurane-nitrous oxide-oxygen post-surgery. An increased frequency of SCE, but not micronuclei, was found in the lymphocytes of operating room personnel exposed to nitrous oxide and isoflurane. An increase in SCE was also found in operating room personnel exposed to halothane and nitrous oxide.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Oxygen. Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOXYGEN.gif CAS number. 7782-44-7.
MW: 32.0.
Nitrous oxide. Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNITROU.gif CAS number. 10024-97-2.
MW: 44.01.
Equanox is a homogenous gas mixture of medical nitrous oxide 50% v/v and medical oxygen 50% v/v.
Nitrous oxide. Complies with European Pharmacopoeia specification 1997 (see Table 3).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/EQUANO03.gif Physical data - nitrous oxide. Molecular weight 44.01.
Physical state in cylinder: Gas at ambient temperature.
Specific gravity of gas at 15°C and 101.3 kPa: 1.53.
Density of gas at 15°C and 101.3 kPa: 1.875 kg/m³.
Combustion characteristics: Non flammable. Strongly supports combustion.
Sweet smelling colourless gas
Boiling point: -88.6°C (at 1 bar).
Nitrous oxide is not very soluble in water but is fifteen times more soluble than oxygen. Water dissolves nitrous oxide, taking 100 volume % and blood plasma 45 volume %.
Chemical characteristics. Nitrous oxide is an oxidising substance which will support combustion of materials which may not normally burn in air. The molecule is stable and comparatively unreactive at ordinary temperatures. At elevated temperatures it decomposes to nitrogen and oxygen. Nitrous oxide will react with powerful reducing agents such as phosphine, stannous chloride and hydrogen. Rust may cause ignitions.
Medical oxygen. Specification - medical oxygen. Complies with European Pharmacopoeia specification 1997.
Purity 99.5% (min).
Carbon dioxide 300.0 vpm (max).
Carbon monoxide 5.0 vpm (max).
Physical data - medical oxygen. Molecular weight 32.00.
Physical state in cylinder: Gas.
Specific gravity of gas at 15°C and 101.3 kPa: 1.106.
Density of gas at 15°C and 101.3 kPa: 1.355 kg/m³.
Combustion characteristics: Non flammable. Strongly supports combustion.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/EQUANOST.gif