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MEDICAL OXYGEN 100% MEDICINAL GAS COMPRESSED

Active substance(s): OXYGEN

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Medical Oxygen 100%
Medicinal gas, compressed
Oxygen

UK-Dolby_OX_P_GO_2014-10

Package leaflet:
information for the user

Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription. However, you still need to
use medicinal oxygen carefully to get the
best results from it.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your
symptoms worsen or do not improve.
• If any of the side effects gets serious,
or if you notice any side effect not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What medicinal oxygen is and what it
is used for
2. Before you use medicinal oxygen
3. How to use medicinal oxygen
4. Possible side effects
5. How to store medicinal oxygen
6. Further information
The full name of this medicine is Medical
Oxygen 100 % Medicinal gas,
compressed. For ease of reference it will
be referred to as medicinal oxygen
throughout the leaflet.
1. WHAT MEDICINAL OXYGEN IS
AND WHAT IT IS USED FOR
Medicinal oxygen contains oxygen, a
gas that is essential for life. Treatment
with oxygen can take place under normal
pressure and under high pressure.
Oxygen therapy at normal pressure
(normobaric oxygen therapy)
Oxygen therapy at normal pressure can
be used to treat:
• low oxygen concentration of the
blood or of a specific organ, or to
prevent this from happening
• cluster headaches (a specific
headache with short and very severe
attacks on one side of the head)

Oxygen therapy at high pressure
Before using oxygen therapy at high
pressure tell your doctor if you have:
• chronic obstructive pulmonary
disease (COPD)
• a disorder of the lungs due to the loss
of elasticity of lung tissue accompanied by
(serious) shortness of breath (lung
emphysema)
• infections in the upper respiratory
tract
• recent middle ear surgery
• had thoracic surgery at any time
• untreated high fever
• serious epilepsy
• fear of confined spaces
(claustrophobia)
• if you have a collapsed lung
(pneumothorax) or ever have had a
collapsed lung which was treated.
Oxygen therapy at high pressure should
be used with caution in pregnancy and
females that can be pregnant.
2. BEFORE YOU USE MEDICINAL
The benefits should outweigh the risks
OXYGEN
and the use should be evaluated in for
Do not use medicinal oxygen
each individual patient.
• For oxygen therapy at high pressure:
Whenever oxygen is used, the increased
untreated collapsed lung (pneumothorax).
risk for spontaneous ignition should be
Inform your doctor if you ever had a
taken into account.
collapsed lung.
Using other medicines
Take special care with medicinal
Before using medicinal oxygen, talk to
oxygen
your doctor or pharmacist if you are taking
Before you start oxygen therapy you
or have recently taken any other
should know the following:
medicines, including medicines obtained
• Oxygen may have harmful effects at
without a prescription.
high concentrations. This may cause the
The use of medicinal oxygen may increase
alveoli (tiny sacs in the lungs) to collapse
or decrease the desirable or undesirable
which will stop the oxygen supply to the
effects of other medicines. Please consult
blood.
your doctor or pharmacist for more
This can happen when using a
information. In particular, talk to your
concentration of:
doctor or pharmacist if you are taking:
- 100% for more than 6 hours
• Amiodarone (a medicine used to treat
- 60 to 70% after more than 24 hours
cardiac arrhythmia).
- during the second day of the treatment
• Bleomycin or actinomycin (anti-cancer
at 40 to 50%
medicine). These medicines can cause
- below 40% after more than 2 days.
lung damage that may be made worse by
• Be extra careful with administering
oxygen therapy, possibly with fatal
oxygen to new-born infants and preconsequences.
term new-born infants. This is to
The following medicines may increase the
minimise the risk of injury such as eye
harmful effects of medicinal oxygen:
damage. The lowest possible oxygen
• Adriamycin (anti-cancer medicine)
concentration that is still effective should
• Menadion (a medicine used to reduce
be used in order to achieve an adequate
the effect of anti-coagulants)
oxygenation. Fluctuations in oxygen
• Promazine, chloropromazine and
saturation should be avoided.
thioridazine (medicines used to fight
• Be extra careful if you have raised
serious mental disorders that cause
carbon dioxide levels in your blood.
patients to lose control over their
In extreme cases this may lead to loss of
behaviour and actions (psychosis))
consciousness.
• If you have breathing problems triggered • Chloroquine (an anti-malarial drug)
by a reduced oxygen level in the blood you • Corticosteroids hormones such as
cortisol, hydrocortisone, prednisolone and
need to be closely monitored by your
many others (drugs that stimulate specific
doctor.
parts of the nervous system)
• If you have ever had a collapsed lung
• Furadantin and similar antibiotics.
please let your doctor know.
• Do not under any circumstance change
the concentration of the oxygen being
supplied as to avoid fluctuations in oxygen
saturation.
Oxygen therapy at high pressure
(hyperbaric oxygen therapy)
Oxygen therapy at high pressure should
only be administered by qualified
healthcare professionals in order to avoid
the risk of injury due to strong fluctuations
in pressure. Oxygen therapy at high
pressure can be used:
• for the treatment of serious carbon
monoxide poisoning (e.g., when the
patient is unconscious)
• for the treatment of the bends
(decompression disease)
• for the treatment of a obstruction in the
heart or blood vessels caused by bubbles
(gas or air embolism)
• for the support treatment in cases of bone
loss after radiotherapy
• for the support treatment in cases of
dying tissue as a result of an injury infected
with gas-producing bacteria

Other effects of medicinal oxygen
• If you have been previously treated for
radical oxygen damage to the lungs
(for example in the treatment of
paraquat poisoning) oxygen therapy
may make this lung damage worse
• The harmful effects of oxygen may
increase in patients who suffer from a
lack of vitamin C, vitamin E or
glutathione (a nutrient needed for
normal function of the immune system).
• The harmful effects of oxygen may be
increased by X-rays
• The harmful effects of oxygen may
increase in patients with an overactive
thyroid.
Using medicinal oxygen with food
and drink.
Do not drink any alcohol during
oxygen therapy. Alcohol can suppress
breathing.
Pregnancy and breast-feeding
• During pregnancy, the use of oxygen
under normal pressure (normobaric
oxygen therapy) is permitted in low
concentrations.
• Only in case of life-saving treatment,
oxygen can also be used during
pregnancy in high concentrations and
at high pressure.
• There are no objections to the use of
oxygen while breast-feeding.
Oxygen therapy at high pressure should
only be used if strictly necessary if you
are pregnant or can be pregnant.
Please inform your treating physician or
specialist in case these conditions
apply to you.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Using medicinal oxygen does not affect
your ability to drive or operate
machines. However, if you feel tired
after using this medicine you should not
drive or operate machinery.

3. HOW TO USE MEDICINAL
OXYGEN
Always use medicinal oxygen exactly
as your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure. Under no
circumstances should you yourself
change the oxygen concentration
administered to you or your child.
Dosage
Oxygen therapy at normal pressure
(normobaric oxygen therapy)
• If the oxygen concentration of the
blood or of a specific organ is too low.
Your doctor will tell you for how long
and how many times a day you should
administer medicinal oxygen because
the dosage can differ from person to
person. The aim is always to use the
lowest possible oxygen concentration
that is still effective. However, the actual
oxygen concentration for inhalation
should never be less than 21%, and
may be increased up to 100%.
• to treat breathing problems because
of reduced oxygen levels in the blood
(hypoxia) or as a breathing stimulus
(e.g. in pulmonary diseases as COPD):
The oxygen concentration will be kept
below 28% and sometimes even lower
than 24%. In the case of new-born
infants, oxygen concentrations for
inhalation should be kept below 40%
and only in very exceptional cases
raised to 100%. The lowest possible
oxygen concentration that is still
effective should be used in order to
achieve an adequate oxygenation.
Fluctuations in oxygen saturation
should be avoided.
• to treat cluster headaches:
100% oxygen is administered at a flow
rate of 7 litres a minute, for a period of
15 minutes using a facial mask.
Treatment should begin when the first
symptoms occur.
How to use oxygen therapy at normal
pressure
• Medicinal oxygen is a gas for
inhalation that is administered using
special equipment, such as a nose
catheter or a facial mask. Any excess
oxygen leaves your body through
exhalation and mixes with the ambient
air (this is called a “non-rebreathing”
system).
• If you cannot breathe independently,
you will be put on artificial breathing.
During anaesthesia, special equipment
with rebreathing or recycling systems is
used so that the exhaled air is inhaled
once again (this is called a
“rebreathing” system).
• Oxygen can also be injected directly
into the bloodstream using an
oxygenator. This technique is used
when the blood needs to be diverted
outside the body, for example in heart
surgery.

The following information
is intended for medical
or healthcare professionals only:
Posology
Preparation prior to use
Follow the instructions of your supplier,
particularly:
• If the gas cylinder is visibly damaged,
or if there is a suspicion of damage or
exposure to extreme temperatures has
occurred, the gas cylinder may not be
used.
• All contact with oil, grease or
hydrocarbons must be avoided.
• Remove the seal from the valve and
the protective cap before use.
• Only equipment suitable for use with a
specific gas cylinder and that specific
gas may be used.
• Check that the quick connector and
regulator are clean and that the
connections are in good condition.
• Open the cylinder valve slowly – at
least half a turn.
• When opening and closing the valve of
a gas cylinder, no pliers or other tools
must be used so as to avoid the risk of
damage.
• No modifications to the form of
packaging must be made.
• Check for leakage in accordance with
the instructions accompanying the
regulator. Do not try to deal with leakage
from the valve or equipment yourself,
other than by changing the gasket or
O-ring.
• In the event of leakage, close the valve
and uncouple the regulator. If the
cylinder continues to leak, empty the
cylinder outdoor. Label defective
cylinders, place them in an area intended
for claims and return them to the
supplier.
• For cylinders with an inbuilt pressure
regulator valve, it is not necessary to use
a separate pressure regulator. The inbuilt
pressure regulator valve has a quick
connector for connecting ‘on demand’
valves, but also a separate outlet for
constant flow of gas, where the flow can
be regulated.

Medical Oxygen 100%
Medicinal gas, compressed
Oxygen

UK-Dolby_OX_P_GO_2014-10

Package leaflet:
information for the user

Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription. However, you still need to
use medicinal oxygen carefully to get the
best results from it.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your
symptoms worsen or do not improve.
• If any of the side effects gets serious,
or if you notice any side effect not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What medicinal oxygen is and what it
is used for
2. Before you use medicinal oxygen
3. How to use medicinal oxygen
4. Possible side effects
5. How to store medicinal oxygen
6. Further information
The full name of this medicine is Medical
Oxygen 100 % Medicinal gas,
compressed. For ease of reference it will
be referred to as medicinal oxygen
throughout the leaflet.
1. WHAT MEDICINAL OXYGEN IS
AND WHAT IT IS USED FOR
Medicinal oxygen contains oxygen, a
gas that is essential for life. Treatment
with oxygen can take place under normal
pressure and under high pressure.
Oxygen therapy at normal pressure
(normobaric oxygen therapy)
Oxygen therapy at normal pressure can
be used to treat:
• low oxygen concentration of the
blood or of a specific organ, or to
prevent this from happening
• cluster headaches (a specific
headache with short and very severe
attacks on one side of the head)

Oxygen therapy at high pressure
Before using oxygen therapy at high
pressure tell your doctor if you have:
• chronic obstructive pulmonary
disease (COPD)
• a disorder of the lungs due to the loss
of elasticity of lung tissue accompanied by
(serious) shortness of breath (lung
emphysema)
• infections in the upper respiratory
tract
• recent middle ear surgery
• had thoracic surgery at any time
• untreated high fever
• serious epilepsy
• fear of confined spaces
(claustrophobia)
• if you have a collapsed lung
(pneumothorax) or ever have had a
collapsed lung which was treated.
Oxygen therapy at high pressure should
be used with caution in pregnancy and
females that can be pregnant.
2. BEFORE YOU USE MEDICINAL
The benefits should outweigh the risks
OXYGEN
and the use should be evaluated in for
Do not use medicinal oxygen
each individual patient.
• For oxygen therapy at high pressure:
Whenever oxygen is used, the increased
untreated collapsed lung (pneumothorax).
risk for spontaneous ignition should be
Inform your doctor if you ever had a
taken into account.
collapsed lung.
Using other medicines
Take special care with medicinal
Before using medicinal oxygen, talk to
oxygen
your doctor or pharmacist if you are taking
Before you start oxygen therapy you
or have recently taken any other
should know the following:
medicines, including medicines obtained
• Oxygen may have harmful effects at
without a prescription.
high concentrations. This may cause the
The use of medicinal oxygen may increase
alveoli (tiny sacs in the lungs) to collapse
or decrease the desirable or undesirable
which will stop the oxygen supply to the
effects of other medicines. Please consult
blood.
your doctor or pharmacist for more
This can happen when using a
information. In particular, talk to your
concentration of:
doctor or pharmacist if you are taking:
- 100% for more than 6 hours
• Amiodarone (a medicine used to treat
- 60 to 70% after more than 24 hours
cardiac arrhythmia).
- during the second day of the treatment
• Bleomycin or actinomycin (anti-cancer
at 40 to 50%
medicine). These medicines can cause
- below 40% after more than 2 days.
lung damage that may be made worse by
• Be extra careful with administering
oxygen therapy, possibly with fatal
oxygen to new-born infants and preconsequences.
term new-born infants. This is to
The following medicines may increase the
minimise the risk of injury such as eye
harmful effects of medicinal oxygen:
damage. The lowest possible oxygen
• Adriamycin (anti-cancer medicine)
concentration that is still effective should
• Menadion (a medicine used to reduce
be used in order to achieve an adequate
the effect of anti-coagulants)
oxygenation. Fluctuations in oxygen
• Promazine, chloropromazine and
saturation should be avoided.
thioridazine (medicines used to fight
• Be extra careful if you have raised
serious mental disorders that cause
carbon dioxide levels in your blood.
patients to lose control over their
In extreme cases this may lead to loss of
behaviour and actions (psychosis))
consciousness.
• If you have breathing problems triggered • Chloroquine (an anti-malarial drug)
by a reduced oxygen level in the blood you • Corticosteroids hormones such as
cortisol, hydrocortisone, prednisolone and
need to be closely monitored by your
many others (drugs that stimulate specific
doctor.
parts of the nervous system)
• If you have ever had a collapsed lung
• Furadantin and similar antibiotics.
please let your doctor know.
• Do not under any circumstance change
the concentration of the oxygen being
supplied as to avoid fluctuations in oxygen
saturation.
Oxygen therapy at high pressure
(hyperbaric oxygen therapy)
Oxygen therapy at high pressure should
only be administered by qualified
healthcare professionals in order to avoid
the risk of injury due to strong fluctuations
in pressure. Oxygen therapy at high
pressure can be used:
• for the treatment of serious carbon
monoxide poisoning (e.g., when the
patient is unconscious)
• for the treatment of the bends
(decompression disease)
• for the treatment of a obstruction in the
heart or blood vessels caused by bubbles
(gas or air embolism)
• for the support treatment in cases of bone
loss after radiotherapy
• for the support treatment in cases of
dying tissue as a result of an injury infected
with gas-producing bacteria

Other effects of medicinal oxygen
• If you have been previously treated for
radical oxygen damage to the lungs
(for example in the treatment of
paraquat poisoning) oxygen therapy
may make this lung damage worse
• The harmful effects of oxygen may
increase in patients who suffer from a
lack of vitamin C, vitamin E or
glutathione (a nutrient needed for
normal function of the immune system).
• The harmful effects of oxygen may be
increased by X-rays
• The harmful effects of oxygen may
increase in patients with an overactive
thyroid.
Using medicinal oxygen with food
and drink.
Do not drink any alcohol during
oxygen therapy. Alcohol can suppress
breathing.
Pregnancy and breast-feeding
• During pregnancy, the use of oxygen
under normal pressure (normobaric
oxygen therapy) is permitted in low
concentrations.
• Only in case of life-saving treatment,
oxygen can also be used during
pregnancy in high concentrations and
at high pressure.
• There are no objections to the use of
oxygen while breast-feeding.
Oxygen therapy at high pressure should
only be used if strictly necessary if you
are pregnant or can be pregnant.
Please inform your treating physician or
specialist in case these conditions
apply to you.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Using medicinal oxygen does not affect
your ability to drive or operate
machines. However, if you feel tired
after using this medicine you should not
drive or operate machinery.

3. HOW TO USE MEDICINAL
OXYGEN
Always use medicinal oxygen exactly
as your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure. Under no
circumstances should you yourself
change the oxygen concentration
administered to you or your child.
Dosage
Oxygen therapy at normal pressure
(normobaric oxygen therapy)
• If the oxygen concentration of the
blood or of a specific organ is too low.
Your doctor will tell you for how long
and how many times a day you should
administer medicinal oxygen because
the dosage can differ from person to
person. The aim is always to use the
lowest possible oxygen concentration
that is still effective. However, the actual
oxygen concentration for inhalation
should never be less than 21%, and
may be increased up to 100%.
• to treat breathing problems because
of reduced oxygen levels in the blood
(hypoxia) or as a breathing stimulus
(e.g. in pulmonary diseases as COPD):
The oxygen concentration will be kept
below 28% and sometimes even lower
than 24%. In the case of new-born
infants, oxygen concentrations for
inhalation should be kept below 40%
and only in very exceptional cases
raised to 100%. The lowest possible
oxygen concentration that is still
effective should be used in order to
achieve an adequate oxygenation.
Fluctuations in oxygen saturation
should be avoided.
• to treat cluster headaches:
100% oxygen is administered at a flow
rate of 7 litres a minute, for a period of
15 minutes using a facial mask.
Treatment should begin when the first
symptoms occur.
How to use oxygen therapy at normal
pressure
• Medicinal oxygen is a gas for
inhalation that is administered using
special equipment, such as a nose
catheter or a facial mask. Any excess
oxygen leaves your body through
exhalation and mixes with the ambient
air (this is called a “non-rebreathing”
system).
• If you cannot breathe independently,
you will be put on artificial breathing.
During anaesthesia, special equipment
with rebreathing or recycling systems is
used so that the exhaled air is inhaled
once again (this is called a
“rebreathing” system).
• Oxygen can also be injected directly
into the bloodstream using an
oxygenator. This technique is used
when the blood needs to be diverted
outside the body, for example in heart
surgery.

The following information
is intended for medical
or healthcare professionals only:
Posology
Preparation prior to use
Follow the instructions of your supplier,
particularly:
• If the gas cylinder is visibly damaged,
or if there is a suspicion of damage or
exposure to extreme temperatures has
occurred, the gas cylinder may not be
used.
• All contact with oil, grease or
hydrocarbons must be avoided.
• Remove the seal from the valve and
the protective cap before use.
• Only equipment suitable for use with a
specific gas cylinder and that specific
gas may be used.
• Check that the quick connector and
regulator are clean and that the
connections are in good condition.
• Open the cylinder valve slowly – at
least half a turn.
• When opening and closing the valve of
a gas cylinder, no pliers or other tools
must be used so as to avoid the risk of
damage.
• No modifications to the form of
packaging must be made.
• Check for leakage in accordance with
the instructions accompanying the
regulator. Do not try to deal with leakage
from the valve or equipment yourself,
other than by changing the gasket or
O-ring.
• In the event of leakage, close the valve
and uncouple the regulator. If the
cylinder continues to leak, empty the
cylinder outdoor. Label defective
cylinders, place them in an area intended
for claims and return them to the
supplier.
• For cylinders with an inbuilt pressure
regulator valve, it is not necessary to use
a separate pressure regulator. The inbuilt
pressure regulator valve has a quick
connector for connecting ‘on demand’
valves, but also a separate outlet for
constant flow of gas, where the flow can
be regulated.

The following information
is intended for medical
or healthcare professionals only:
Using the gas cylinder
• The transferring of gas under
pressure is prohibited.
• Smoking and open flames are strictly
forbidden in rooms where treatment
with medicinal oxygen takes place.
• When the cylinder is in use it must be
fixed in a suitable support.
• One should consider replacing the
gas cylinder when the pressure in the
bottle has dropped to a point where the
indicator on the valve is within the
yellow field.
• When a small quantity of gas is left in
the gas cylinder, the cylinder valve must
be closed. It is important that a small
amount of pressure is left in the cylinder
to avoid the entrance of contaminants.
• Valves of empty gas cylinders must
be closed.
• After use the cylinder valve must be
closed hand-tight. Depressurise the
regulator or connection.

How to receive oxygen therapy at
high pressure
• Oxygen therapy at high pressure
should only be administered by
healthcare professionals in order to
avoid the risk of injury due to strong
fluctuations in pressure.
• Depending on your condition,
oxygen therapy under high pressure
lasts 45 to 300 minutes per treatment
session. The therapy sometimes
includes one or two sessions, but
long-term therapy can take up to 30
sessions or more, and multiple
sessions a day if necessary.
• Oxygen therapy is given in a special
pressure room.
• Oxygen therapy at high pressure
can also be provided using a closefitting facial mask with a hood
covering the head or through a tube in
your mouth.
If you use more medicinal oxygen
than you should
If you have used more oxygen than
you should, you should contact your
doctor or pharmacist immediately.
The toxic effects of oxygen vary
according to the pressure of the
inhaled oxygen and the duration of
exposure.
At low pressure (0.5 to 2.0 bar) toxic
effects are more likely to occur in the
lungs (pulmonary region) than in the
brain and spinal cord (central nervous
system). At higher pressure, the
opposite applies.
The effects in the lungs (pulmonary
region) include shortness of breath,
coughing and chest pain.
The effects in the brain and spinal
cord (central nervous system) include
nausea, dizziness, anxiety and
confusion, muscle cramps, loss of
consciousness, and seizures (epileptic
fits).
If you forget to use medicinal
oxygen
Use the oxygen as described in the
dosage section of the leaflet. Do not
use a double dose to make up for a
forgotten dose. This is because
medicinal oxygen may be harmful in
high concentrations.
If you stop using medicinal oxygen
Do not stop using this medicinal
product at your own initiative. Ask
your doctor or pharmacist.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicinal products, medicinal
oxygen can cause side effects, although
not everybody gets them. The side
effects have been grouped according to
therapy.
Oxygen therapy at normal pressure
may result in:
• a slight reduction in pulse
• heart failure
• shortness of breath
• chest pain
• fatigue
• inflammation of the tissue that lines the
lungs and chest cavity (pleuritis)
• severe lung disease
In patients with breathing disorders
whose breathing is triggered by a
reduced oxygen level in the blood, the
administration of oxygen may further
reduce breathing effectiveness, and can
result in an accumulation of carbon
dioxide and excessive acid in the body
(acidosis).
In new-born infants and pre-term newborn infants the administration of oxygen
may result in eye damage, malformations
of the lungs, bleeding in the heart, brain
or spinal cord, and in inflammation and
necrosis of intestines (necrotising
enterocolitis). You should notify your
doctor about even the smallest change in
the baby’s’ medical condition.
Oxygen therapy at high pressure may
result in:
• temporary loss of eyesight
• nausea
• dizziness
• anxiety and confusion
• muscle cramps
• loss of consciousness
• seizures (epileptic fits)
• damage to the middle ear caused by
pressure fluctuations
• damage to the lungs due to pressure
fluctuations
• pain, possibly accompanied by
inflammation and bleeding in the
paranasal sinuses caused by pressure
fluctuations
• aching muscles
These undesirable effects may disappear
in the course of time.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE MEDICINAL
OXYGEN
Keep out of the reach and sight of
children.
Do not use medicinal oxygen after the
expiry date which is stated on the gas
cylinder after the abbreviation EXP.
• The gas cylinders should be stored
between -20°C and +65°C.
• The gas cylinders should be stored
vertically, except gas cylinders with a
convex bottom; these should be stored
horizontally, or in a crate.
• The gas cylinders should be protected
from falling over or from mechanical
shocks, for example, by fixing the gas
cylinders or placing them in a crate.
• The gas cylinders should be stored in a
well-ventilated room that is exclusively
used for the storage of medicinal gases.
This storage room must not contain any
inflammable materials.
• Gas cylinders containing a different
kind of gas, or a gas that has a different
composition, should be stored
separately.
• Full and empty gas cylinders should be
stored separately.
• The gas cylinders must not be stored
near sources of heat.
• Gas cylinders must be stored covered
and protected against the effects of the
weather.
• Close the valves of the cylinders after
use.
• Return cylinder to the supplier when
empty.
• Warning notices prohibiting smoking
and naked lights must be posted clearly
in the storage area.
• Emergency services should be advised
of the location of the cylinder storage.

6. FURTHER INFORMATION
What Medical Oxygen contains
• The active substance is oxygen,
100% v/v.
• There are no other ingredients.
What Medical Oxygen looks like and
contents of the pack
Medicinal oxygen is an inhalation gas.
It is supplied as a liquid or gas in a special
container.
Oxygen is a colourless, tasteless and
odourless gas.
In liquid state it has a blue colour.
Medicinal oxygen is stored in gas
cylinders in a gaseous state and under a
pressure of 200, 230 or 300 bar (at 15°C).
The cylinders are made of steel or
aluminium. The valves are made of brass,
steel or aluminium.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Dolby Medical Home Respiratory Care Ltd
North Suite, Lomond Court
Castle Business Park, Stirling, FK9 4TU
United Kingdom
Manufacturer
B.T.G. Sprl
Zoning Ouest, 15
7860 Lessines, Belgium
Dolby Medical Home Respiratory Care Ltd
Unit 18, Arkwright Road Industrial Estate
Arkwright Road, Bedford, MK42 0LQ
United Kingdom
Dolby Medical Home Respiratory Care Ltd
Unit 2, Springkerse Industrial Estate
Broadleys Road, Stirling, FK7 7ST
United Kingdom
This leaflet was last approved
in 10/2014

Gas cylinders with a content of (x) litres deliver (y) m³ of oxygen at 15°C
and 1 bar when filled to 200 bar.
Content in litres (x)

1

2

5

10

20

30

Number of m³ of
oxygen (y)

0.212

0.425

1.125

2.12

4.33

6.37

Content in litres (x)

50

4x50

8x50

12x50

16x50

20x50

Number of m³ of
oxygen (y)

10.61

42.5

85.0

127.5

170.0

212.0

The shoulder of the cylinder is colour-coded in white. The colour of the cylinder body is white.
The gas cylinders, valves and valve outlets conform to relevant EU standards. Not all cylinder sizes may be marketed.

Gas cylinders with a content of (x) litres deliver (y) m³ of oxygen at 15°C
and 1 bar when filled to 230 bar.
Content in litres (x)

1

2

5

10

20

30

Number of m³ of
oxygen (y)

0.240

0.480

1.200

2.400

4.800

7.200

Content in litres (x)

50

4x50

8x50

12x50

16x50

20x50

Number of m³ of
oxygen (y)

12.00

48.00

96.00

144.0

192.0

240.0

The shoulder of the cylinder is colour-coded in white. The colour of the cylinder body is white.
The gas cylinders, valves and valve outlets conform to relevant EU standards. Not all cylinder sizes may be marketed.

Gas cylinders with a content of (x) litres deliver (y) m³ of oxygen at 15°C
and 1 bar when filled to 300 bar.
Content in litres (x)

1

2

5

10

20

30

Number of m³ of
oxygen (y)

0.308

0.616

1.54

3.08

6.16

9.24

Content in litres (x)

50

4x50

8x50

12x50

16x50

20x50

Number of m³ of
oxygen (y)

15.4

61.6

123

185

246

308

The shoulder of the cylinder is colour-coded in white. The colour of the cylinder body is white.
The gas cylinders, valves and valve outlets conform to relevant EU standards. Not all cylinder sizes may be marketed.

The following information
is intended for medical
or healthcare professionals only:
Using the gas cylinder
• The transferring of gas under
pressure is prohibited.
• Smoking and open flames are strictly
forbidden in rooms where treatment
with medicinal oxygen takes place.
• When the cylinder is in use it must be
fixed in a suitable support.
• One should consider replacing the
gas cylinder when the pressure in the
bottle has dropped to a point where the
indicator on the valve is within the
yellow field.
• When a small quantity of gas is left in
the gas cylinder, the cylinder valve must
be closed. It is important that a small
amount of pressure is left in the cylinder
to avoid the entrance of contaminants.
• Valves of empty gas cylinders must
be closed.
• After use the cylinder valve must be
closed hand-tight. Depressurise the
regulator or connection.

How to receive oxygen therapy at
high pressure
• Oxygen therapy at high pressure
should only be administered by
healthcare professionals in order to
avoid the risk of injury due to strong
fluctuations in pressure.
• Depending on your condition,
oxygen therapy under high pressure
lasts 45 to 300 minutes per treatment
session. The therapy sometimes
includes one or two sessions, but
long-term therapy can take up to 30
sessions or more, and multiple
sessions a day if necessary.
• Oxygen therapy is given in a special
pressure room.
• Oxygen therapy at high pressure
can also be provided using a closefitting facial mask with a hood
covering the head or through a tube in
your mouth.
If you use more medicinal oxygen
than you should
If you have used more oxygen than
you should, you should contact your
doctor or pharmacist immediately.
The toxic effects of oxygen vary
according to the pressure of the
inhaled oxygen and the duration of
exposure.
At low pressure (0.5 to 2.0 bar) toxic
effects are more likely to occur in the
lungs (pulmonary region) than in the
brain and spinal cord (central nervous
system). At higher pressure, the
opposite applies.
The effects in the lungs (pulmonary
region) include shortness of breath,
coughing and chest pain.
The effects in the brain and spinal
cord (central nervous system) include
nausea, dizziness, anxiety and
confusion, muscle cramps, loss of
consciousness, and seizures (epileptic
fits).
If you forget to use medicinal
oxygen
Use the oxygen as described in the
dosage section of the leaflet. Do not
use a double dose to make up for a
forgotten dose. This is because
medicinal oxygen may be harmful in
high concentrations.
If you stop using medicinal oxygen
Do not stop using this medicinal
product at your own initiative. Ask
your doctor or pharmacist.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicinal products, medicinal
oxygen can cause side effects, although
not everybody gets them. The side
effects have been grouped according to
therapy.
Oxygen therapy at normal pressure
may result in:
• a slight reduction in pulse
• heart failure
• shortness of breath
• chest pain
• fatigue
• inflammation of the tissue that lines the
lungs and chest cavity (pleuritis)
• severe lung disease
In patients with breathing disorders
whose breathing is triggered by a
reduced oxygen level in the blood, the
administration of oxygen may further
reduce breathing effectiveness, and can
result in an accumulation of carbon
dioxide and excessive acid in the body
(acidosis).
In new-born infants and pre-term newborn infants the administration of oxygen
may result in eye damage, malformations
of the lungs, bleeding in the heart, brain
or spinal cord, and in inflammation and
necrosis of intestines (necrotising
enterocolitis). You should notify your
doctor about even the smallest change in
the baby’s’ medical condition.
Oxygen therapy at high pressure may
result in:
• temporary loss of eyesight
• nausea
• dizziness
• anxiety and confusion
• muscle cramps
• loss of consciousness
• seizures (epileptic fits)
• damage to the middle ear caused by
pressure fluctuations
• damage to the lungs due to pressure
fluctuations
• pain, possibly accompanied by
inflammation and bleeding in the
paranasal sinuses caused by pressure
fluctuations
• aching muscles
These undesirable effects may disappear
in the course of time.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE MEDICINAL
OXYGEN
Keep out of the reach and sight of
children.
Do not use medicinal oxygen after the
expiry date which is stated on the gas
cylinder after the abbreviation EXP.
• The gas cylinders should be stored
between -20°C and +65°C.
• The gas cylinders should be stored
vertically, except gas cylinders with a
convex bottom; these should be stored
horizontally, or in a crate.
• The gas cylinders should be protected
from falling over or from mechanical
shocks, for example, by fixing the gas
cylinders or placing them in a crate.
• The gas cylinders should be stored in a
well-ventilated room that is exclusively
used for the storage of medicinal gases.
This storage room must not contain any
inflammable materials.
• Gas cylinders containing a different
kind of gas, or a gas that has a different
composition, should be stored
separately.
• Full and empty gas cylinders should be
stored separately.
• The gas cylinders must not be stored
near sources of heat.
• Gas cylinders must be stored covered
and protected against the effects of the
weather.
• Close the valves of the cylinders after
use.
• Return cylinder to the supplier when
empty.
• Warning notices prohibiting smoking
and naked lights must be posted clearly
in the storage area.
• Emergency services should be advised
of the location of the cylinder storage.

6. FURTHER INFORMATION
What Medical Oxygen contains
• The active substance is oxygen,
100% v/v.
• There are no other ingredients.
What Medical Oxygen looks like and
contents of the pack
Medicinal oxygen is an inhalation gas.
It is supplied as a liquid or gas in a special
container.
Oxygen is a colourless, tasteless and
odourless gas.
In liquid state it has a blue colour.
Medicinal oxygen is stored in gas
cylinders in a gaseous state and under a
pressure of 200, 230 or 300 bar (at 15°C).
The cylinders are made of steel or
aluminium. The valves are made of brass,
steel or aluminium.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Dolby Medical Home Respiratory Care Ltd
North Suite, Lomond Court
Castle Business Park, Stirling, FK9 4TU
United Kingdom
Manufacturer
B.T.G. Sprl
Zoning Ouest, 15
7860 Lessines, Belgium
Dolby Medical Home Respiratory Care Ltd
Unit 18, Arkwright Road Industrial Estate
Arkwright Road, Bedford, MK42 0LQ
United Kingdom
Dolby Medical Home Respiratory Care Ltd
Unit 2, Springkerse Industrial Estate
Broadleys Road, Stirling, FK7 7ST
United Kingdom
This leaflet was last approved
in 10/2014

Gas cylinders with a content of (x) litres deliver (y) m³ of oxygen at 15°C
and 1 bar when filled to 200 bar.
Content in litres (x)

1

2

5

10

20

30

Number of m³ of
oxygen (y)

0.212

0.425

1.125

2.12

4.33

6.37

Content in litres (x)

50

4x50

8x50

12x50

16x50

20x50

Number of m³ of
oxygen (y)

10.61

42.5

85.0

127.5

170.0

212.0

The shoulder of the cylinder is colour-coded in white. The colour of the cylinder body is white.
The gas cylinders, valves and valve outlets conform to relevant EU standards. Not all cylinder sizes may be marketed.

Gas cylinders with a content of (x) litres deliver (y) m³ of oxygen at 15°C
and 1 bar when filled to 230 bar.
Content in litres (x)

1

2

5

10

20

30

Number of m³ of
oxygen (y)

0.240

0.480

1.200

2.400

4.800

7.200

Content in litres (x)

50

4x50

8x50

12x50

16x50

20x50

Number of m³ of
oxygen (y)

12.00

48.00

96.00

144.0

192.0

240.0

The shoulder of the cylinder is colour-coded in white. The colour of the cylinder body is white.
The gas cylinders, valves and valve outlets conform to relevant EU standards. Not all cylinder sizes may be marketed.

Gas cylinders with a content of (x) litres deliver (y) m³ of oxygen at 15°C
and 1 bar when filled to 300 bar.
Content in litres (x)

1

2

5

10

20

30

Number of m³ of
oxygen (y)

0.308

0.616

1.54

3.08

6.16

9.24

Content in litres (x)

50

4x50

8x50

12x50

16x50

20x50

Number of m³ of
oxygen (y)

15.4

61.6

123

185

246

308

The shoulder of the cylinder is colour-coded in white. The colour of the cylinder body is white.
The gas cylinders, valves and valve outlets conform to relevant EU standards. Not all cylinder sizes may be marketed.

Expand view ⇕

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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