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LIQUID MEDICAL OXYGEN 100% MEDICINAL GAS CRYOGENIC

Active substance(s): OXYGEN

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Liquid
Medical Oxygen 100%
Medicinal gas, cryogenic
oxygen

UK_Dolby_OX_P_LO_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 Liquid Medical
Oxygen 100 % Medicinal gas, cryogenic. 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
(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

2. BEFORE YOU USE MEDICINAL OXYGEN
Do not use medicinal oxygen
• For oxygen therapy at high pressure: untreated
collapsed lung (pneumothorax). Inform your doctor
if you ever had a collapsed lung.
Take special care with medicinal oxygen
Before you start oxygen therapy you should know the
following:
• Oxygen may have harmful effects at high
concentrations. This may cause the alveoli (tiny
sacs in the lungs) to collapse which will stop the
oxygen supply to the blood. This can happen
when using a concentration of:
- 100% for more than 6 hours
- 60 to 70% after more than 24 hours
- during the second day of the treatment at 40 to 50%
- below 40% after more than 2 days.
• Be extra careful with administering oxygen to
new-born infants and pre-term new-born
infants. This is to minimise the risk of injury such
as eye damage. 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.
• Be extra careful if you have raised carbon dioxide
levels in your blood. In extreme cases this may
lead to loss of consciousness.
• If you have breathing problems triggered by a
reduced oxygen level in the blood you need to be
closely monitored by your doctor.
• If you have ever had a collapsed lung 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
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. The benefits should outweigh the risks and
the use should be evaluated in for each individual
patient.
Whenever oxygen is used, the increased risk for
spontaneous ignition should be taken into account.
Using other medicines
Before using medicinal oxygen, talk to your doctor or
pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained
without a prescription.
The use of medicinal oxygen may increase or
decrease the desirable or undesirable effects of other
medicines. Please consult your doctor or pharmacist
for more information. In particular, talk to your doctor
or pharmacist if you are taking:
• Amiodarone
(a medicine used to treat cardiac arrhythmia).
• Bleomycin or actinomycin
(anti-cancer medicine). These medicines can
cause lung damage that may be made worse by
oxygen therapy, possibly with fatal consequences.
The following medicines may increase the harmful
effects of medicinal oxygen:
• Adriamycin (anti-cancer medicine)
• Menadion
(a medicine used to reduce the effect of anti-
coagulants)
• Promazine, chloropromazine and thioridazine
(medicines used to fight serious mental disorders
that cause patients to lose control over their
behaviour and actions (psychosis)

• Chloroquine (an anti-malarial drug)
• Corticosteroids hormones such as cortisol,
hydrocortisone, prednisolone and many others
(drugs that stimulate specific parts of the nervous
system)
• Furadantin and similar antibiotics.
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.
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 close-fitting 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 new-born 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 side of the Mobile cryogenic
vessel after the abbreviation EXP.
- Keep the vessel in a well-ventilated area within a
temperature range of -20°C and +50°C.
- Keep away from inflammable and combustible
materials and sources of heat or open fire.
- Do not smoke near the vessel.
- The transport must be conducted in accordance
with international regulations for transporting
dangerous materials.
- Avoid any contact with oil, grease or hydrocarbons.
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.

Liquid Medical Oxygen is packed in mobile cryogenic
vessels. Mobile cryogenic vessels are made of an
outer and an inner vessel of stainless steel with a
vacuum insulation layer in between and fitted with
dedicated filling port and withdrawal hose
connection.
These vessels contain oxygen in the liquid state at
very low temperature.
The content of the vessels varies from 10 to 100
litres.
Each litre of liquid oxygen delivers 853 litres of
oxygen gas at 15°C and 1 bar.
Vessel content
in litres

Capacity
for liquid oxygen
in litres

Equivalent amount of
gaseous oxygen in m³
at 15°C and 1 atm

10

10

8,53

1100

938,3

to
1100

Not all vessel sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dolby Medical
Home Respiratory Care Limited
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 Limited
Unit 18, Arkwright Road Industrial Estate
Arkwright Road, Bedford
MK42 0LQ, United Kingdom
Dolby Medical Home Respiratory Care Limited
Unit 2, Springkerse Industrial Estate
Broadleys Road, Stirling
FK7 7ST, United Kingdom
Medical Gas Solutions Ltd
Unit 19, Manor Industrial Estate,
Bagillt, Flint, CH6 5UY
United Kingdom
Medical Gas Solutions Ltd
Unit 10, Watling Street Business Park
Watling Street, Cannock, WS11 9XG
United Kingdom
This leaflet was last approved in 08/2015

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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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