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MEDICAL OXYGEN

Active substance(s): OXYGEN

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Medical Oxygen 100% Inhalation Gas -Patient Information Leaflet
Read all of this leaflet carefully because it contains important information for you. Keep this leaflet, you may need to read it again. Ask
your pharmacist or doctor if you need more information or advice

In this Leaflet
Page 1

1. What is Medical Oxygen 100% Inhalation Gas and what it is
used for
2. Before you use Medical Oxygen 100% Inhalation Gas

Page 2

3. How to use Medical Oxygen 100% Inhalation
Gas
4. Possible side effects
5. How to store Medical Oxygen 100%
Inhalation Gas
6. Further information

1. What is Medical Oxygen 100% Inhalation Gas and what it is used for?
Medical Oxygen 100% Inhalation Gas is a breathed in (inhalation) gas. It is colourless, odourless and tasteless. It is supplied under
pressure in a cylinder with a valve to control the flow of gas. A variety of cylinder sizes are available.
What Medical Oxygen 100% Inhalation Gas is used for?
Medical Oxygen 100% Inhalation Gas is used to increase levels of oxygen in the body’s tissues. It may be used in the following
circumstances:

at high concentration when there is a reduced amount of oxygen being taken into the body through the lungs due to acute or
severe asthma or lung diseases such as pulmonary thrombo-embolism (a blockage of one of the arteries in the lung),
pneumonia fibrosing alveolistis (inflammation and scarring of the air sacs of the lungs) and pulmonary oedema (a disease
affecting the heart)

in low concentrations when there are breathing difficulties due to conditions such as chronic obstructive airways disease
(COAD/COPD) (a collection of lung diseases caused by damage to the lungs)

in the treatment of acute and severe asthma, sleep apnoea (a sleep disorder in which a person has irregular breathing at night
and is excessively sleepy during the day), cluster headaches (attacks of severe, one sided headaches over several weeks),
shock (a dramatic reduction in blood flow that, if left untreated, can lead to collapse, coma and even death) and in other
situations where localised blood supply is poor.

for resuscitation purposes by trained persons, where oxygen supply to the body is reduced due to medical emergency

when the oxygen capability of the blood is reduced such as in carbon monoxide poisoning or severe anaemia (a condition
which occurs when there is a reduced number of red blood cells or haemoglobin concentration)

when gas is trapped in body spaces such as in pneumothorax (air that is trapped next to a lung resulting in collapse of the lung)
or air embolism or other gas disturbances such as decompression sickness (associated with diving)

as a carrier gas or as a diluent for anaesthetic gases or vapours.

2. Before you use Medical Oxygen 100% Inhalation Gas
Interactions with other medicines, medical conditions or diseases
Interactions with other medicines are unlikely when used as directed. However, it is important that you tell your doctor if you are taking, or
have recently taken, any other medicine – even those not prescribed. Unless specially advised by your doctor to do so, do not use
Medical Oxygen 100% Inhalation Gas if:

you are taking or have recently taken aminodarone (used to treat irregular heart beat) or bleomycin (given as an injection or
drip to treat some types of cancer)

you have a Chronic Obstructive Pulmonary Disease (COPD) (a collection of lung diseases caused by damage to the lungs).
Take special care with Medical Oxygen 100% Inhalation Gas
Care is needed in the handling and use of Medical Oxygen 100% Inhalation Gas-You must follow your Doctor’s instructions.
Fire Risks:

do not smoke or allow those near you to smoke during treatment with Medical Oxygen 100% Inhalation Gas smoking during
oxygen treatment has caused serious injuries and can prove fatal .

do not allow naked flames in the area where you are using your Medical Oxygen 100% Inhalation Gas, since even the smallest
spark can cause violent ignition; electrical equipment capable of sparking (including toys which may produce sparks) must not
be used where you are using your Medical Oxygen 100% Inhalation Gas.
Medical Risks:

if oxygen is being used for a premature or newborn infant, they must receive a carefully monitored dose of oxygen. Giving too
much oxygen can damage their sight

if you have a chronic obstructive airway disease you must receive a carefully monitored dose of oxygen

although Medical Oxygen 100% Inhalation Gas is necessary for patients with lung damage due to poisons such as paraquat (a
type of weed killer), it may worsen the lung injury; the dose must be monitored carefully
Taking Alcohol and Other Risks

a slowing down in your breathing caused by drinking alcohol may be made worse by the use of Medical Oxygen 100%
Inhalation Gas

do not breathe Medical Oxygen 100% Inhalation Gas at pressures higher than atmospheric pressure.
Special Circumstances:
Pregnancy.
Medical Oxygen 100% Inhalation Gas can be used if you are pregnant, however, seek medical advice before taking any medicine.
Premature/Newborn Babies
Medical Oxygen 100% Inhalation Gas for premature or newborn babies should only be taken under the direction of a qualified medical
person.
Breast-feeding
Medical Oxygen 100% Inhalation Gas can be used if you are breast-feeding, however, seek medical advice before taking any medicine.
Driving and using machines
Non-continuous use of Medical Oxygen 100% Inhalation Gas at atmospheric pressure will not affect your ability to drive or operate
machinery. However, if you are using oxygen continuously you must be assessed by your doctor

3. How to use Medical Oxygen 100% Inhalation Gas
Medical Oxygen 100% Inhalation Gas will be administered via inhalation and you will be given a facemask, mouthpiece or nasal cannula
(prongs) to use which are connected to Medical Oxygen 100% Inhalation Gas via a suitable medical device. The device must be operated
in the manner described by the manufacturer. The amount of oxygen you will receive is controlled by the type of equipment that you are
supplied with and the flow rate. You must use the flow rate prescribed by your doctor and the equipment provided.
The flow rate of oxygen used in your treatment will depend on the conditions it is being used to treat. Your doctor will tell you how much
oxygen you should use per day and how long your treatment with Medical Oxygen 100% Inhalation Gas is likely to last.
Other systems used to administer oxygen include face tents, headboxes, cot hoods a positive pressure mask or supply to a tracheotomy.
These systems will only be used to give you oxygen under the direct supervision of attendant and suitably trained medical personnel.
Connections for hoses, valves etc. must be kept clean and dry. If necessary clean only with plain water. Do not use solvents. Use clean,
lint free cloths for cleaning and drying off. Do not use oil or grease on any oxygen equipment.
Premature/Newborn Babies
Medical Oxygen 100% Inhalation Gas for premature or newborn babies should only be taken under direction of a qualified medical
person.
If you use more Medical Oxygen 100% Inhalation Gas than you should:
If you may have used more Medical Oxygen 100% Inhalation Gas than you should, talk to a doctor or pharmacist as soon as possible.
However, it is very unlikely that an over dose will occur.
Using 100% Medical oxygen 100% Inhalation Gas continuously for more than a day may produce chest pain and difficulties in breathing.
Such a concentration is likely only to be achieved using specialised (hospital) equipment.
Using Medical oxygen 100% Inhalation Gas at pressure higher than atmospheric may lead to convulsions. This is only likely to occur in
specialised circumstances when using decompression units, high altitude mountaineering or diving
Withdrawal
There are no additional side-effects from withdrawal of oxygen.

4 Possible side effects.
Like all medicines Medical Oxygen 100% Inhalation Gas can have side effects. The toxicity of Medical Oxygen 100% Inhalation Gas
depends upon both the pressure (concentration) of Medical Oxygen 100% Inhalation Gas that is breathed in and the amount of time that it
is used for. The higher the pressure that Medical Oxygen Inhalation Gas is breathed in at, the shorter the time that it can safely be used
for.
Side-effects may include:

giving too much oxygen in newborn and premature infants can damage their sight and may be associated with other damage
(these conditions have more than one cause and can occur even in the absence of oxygen therapy)

lung damage from prolonged giving too much oxygen – symptoms include shortness of breath, cough and chest discomfort

central nervous system toxicity if Medical Oxygen 100% Inhalation Gas is breathed in at pressures of twice atmospheric
pressure or more as in hyperbaric oxygen therapy. This would normally only occur in specialist hospital treatment. Symptoms
could include nausea, mood changes, vertigo, twitching, convulsions and loss of consciousness.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.

5. How to Store Medical Oxygen Inhalation Gas
Check the date given on the batch label attached to the cylinder. Do Not Use Medical Oxygen 100% Inhalation Gas after the expiry date
given on the label.
Medical Oxygen 100% Inhalation Gas is supplied in cylinders as a gas
1. Keep Medical Oxygen 100% Inhalation Gas out of the reach and sight of children.
2. Medical Oxygen 100% Inhalation Gas should be stored securely in a well-ventilated place, under cover and kept clean and dry.
3. Medical Oxygen 100% Inhalation Gas must be stored at temperatures below 50oC and they should preferably be stored
between 10oC and 30oC.
4. Medical Oxygen 100% Inhalation Gas must be stored separately from other medical gases and non-medical gases.

6. Further information
The name of your medicine is Medical Oxygen 100% Inhalation Gas, commonly named as Oxygen Inhalation Gas.
The active substance is Oxygen Ph. Eur., Minimum Purity 99.5% v/v.
Medical Oxygen 100% Inhalation Gas is supplied as a gas in cylinders. These contain compressed gas. The cylinder label gives the
amount of oxygen provided by the cylinder when it is used at normal atmospheric pressure.
Further information on handling and using Medical Oxygen Inhalation Gas is available from Medical Gas Solutions
The Distributor and Supplier of this product is:
Baywater Healthcare UK Limited:
Wholesale Dealers Authorisation Number: WDA(H) 42707
The Manufacturer and Marketing Authorisation holder is:
Medical Gas Solutions Ltd, Unit 19, Manor Industrial Estate, Bagillt, Flintshire, CH6 5UY.
Manufacturing Authorisation Number MIA No. 17872, Marketing Authorisation Number PL 17872/0002
This leaflet was approved October 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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