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MEDICINAL AIR SYNTHETIC 21.75% V/V MEDICINAL GAS COMPRESSED

Active substance(s): OXYGEN

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Medicinal air synthetic
21.75% v/v

UK_AIR_P_2015-06

Package leaflet:
information for the user

Medicinal gas, compressed
Oxygen

1. What Medicinal air synthetic is
and what it is used for
Medicinal air synthetic is an inhalation gas and
belongs to the group of medicinal gases.This
medicine is used to prevent oxygen deficiency
where treatment with atmospheric air is
indicated.
2. What you need to know before
you use Medicinal air synthetic
Do not use Medicinal air synthetic
There are no known situations in which this
medicine cannot be used.

Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
Always use this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.
• Keep this leaflet. You may need to read it
again.
• Ask your doctor or pharmacist if you need
more information or advice.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects nog listed in this leaflet. See
section 4.
• You must talk to a doctor if you do not feel
better or if you feel worse after 14 days.
What is in this leaflet:
1. What Medicinal air synthetic is and what it is
used for
2. What you need to know before you use
Medicinal air synthetic
3. How to use Medicinal air synthetic
4. Possible side effects
5. How to store Medicinal air synthetic
6. Contents of the pack and other information

Warnings and precautions
Talk to your doctor or pharmacist before using
this medicine.
• Before treatment with medicinal air synthetic,
ensure that it is administered at atmospheric
pressure.
• The administration of pressurised medicinal
air synthetic may cause decompression
sickness and oxygen toxicity.
Decompression sickness is a disease that
occurs during the transition from high
pressure to normal pressure and causes
headache, nausea, and confusion, and
sometimes paralysis and un-consciousness
(and even death).
• If medicinal air is mixed with other
inhalational gases, there should be sufficient
oxygen (at least 21% v/v) in this gas mixture.
Therefore mixtures of medicinal air with
other gases must always include additional
oxygen from other sources.
• If you administer medicinal air at a high flow
rate because it may feel cold.
• Medicinal air should not be used where
higher than atmospheric concentrations of
oxygen (>21%) would be indicated.
Other medicines and Medicinal air
synthetic
It is not known whether this medicine may
affect the use of other medicines.
Tell your doctor or pharmacist if you are taking;
have recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
This medicine can be used if you are pregnant
or breast-feeding.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
This medicine does not affect the ability to
drive and use machines.
3. How to use Medicinal air
synthetic
Dosage
The dosage depends on the clinical situation
and should be adjusted to the patient’s needs.
Check with your doctor or pharmacist if you are
not sure.
How to use Medicinal air synthetic
In order to be able to use medicinal air, the high
pressure in the cylinder must be reduced to the
required pressure using a reducing device.
If you need to use medicinal air for a long
period, it is recommended that the medicinal
air is humidified.

Your healthcare professional will ensure that
your medicinal air supply is suitable for your
use and that the equipment has been set up
correctly so that you receive the right amount
of air.
This medicine is a gas for inhalation and is
administered with inhaled air via a special
device, such as a nasal catheter, a face mask,
with a hood that fits around the head or by a
tube into the windpipe (tracheotomy). The
device must be used as per the manufacturer’s
instructions.
Any excess air leaves your body through
breathing out and is mixed with the
surrounding air.
If you are unable to breathe by yourself, you
may receive artificial ventilation.
BEFORE USE
• Remove tamper evident seal
• Ensure connecting faces are clean
• Check sealing washer condition
• Open cylinder valve slowly
• Check for leaks
AFTER USE
• Close cylinder valve when not in use
• Close valve slowly with moderate force
Follow your supplier’s instructions,
particularly with regard to the following:
• The gas cylinder must not be used if it is
visibly damaged or is suspected of having
been damaged or exposed to extreme
temperatures.
• All contact with oil, grease or other
hydrocarbons (like vaseline, vaseline
containing creams) must be avoided.
• Only equipment suitable for the specific type
of gas cylinder and gas should be used.
• No tongs or other tools should be used to
open or close the gas cylinder valve to
prevent risk of damage.
• No change to the way the cylinder is packed
should be made.
• In the event of leakage, the cylinder valve
must be closed immediately, if this is safe to
do so. If the valve cannot be closed, the
cylinder must be taken to a safe place to let it
empty in the open air.
• Valves of empty cylinders must be closed.
• Connections for tubes, valves, etc. must be
clean and dry. If necessary, clean them
according to the supplier’s instructions.
Do not use any solvents. Use clean, lint-free
cloths for cleaning and drying.
• The siphoning of gas under pressure is not
permitted.
• Smoking or naked flames are not permitted
near gas cylinders.
If you use more Medicinal air synthetic than
you should
There are no known risks of overdose with this
medicine.
If you forget to use Medicinal air synthetic
Use this medicine as soon as you remember.
Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Marketing Authorization Holder
SOL S.p.A.
Via Borgazzi, 27
Reporting of side effects
20900 Monza,
If you get any side effects, talk to your doctor or Italy
pharmacist. This includes any possible side
Manufacturer
effects not listed in this leaflet. You can also
NTG B.V.
report side effects directly via the Yellow Card
Swaardvenstraat 11
Scheme (website: www.mhra.gov.uk/
5048 AV Tilburg
yellowcard). By reporting side effects you can
The Netherlands
help provide more information on the safety of
BTG Sprl
this medicine.
Zoning Ouest 15
5. How to store Medicinal Air
7860 Lessines
synthetic
Belgium
Keep this medicine out of the sight and reach
SOL Hellas S.A.
of children.
Thesi Paxi Patima Stefanis
Do not use this medicine after the expiry date
19200 Kamari Boiotias
which is stated on the gas cylinder after “do
Greece
not use after” or “exp”. The expiry date refers
Local representative
to the last day of that month.
BTG Gases
The following safety precautions must be
SOL House Station Road Harrietsham
followed when storing the gas cylinders:
Maidstone – ME 17 1 JA
• Store between -20°C and +65°C.
• Store in a vertical position. For cylinders with United Kingdom
a rounded base, store horizontally or in a
This medicinal product is authorised in the
crate.
Member States of the EEA under the
• Protect from falling or shock, by taking
following names:
appropriate precautions such as securing the
Belgium: Lucht synthetisch medicinaal SOL
cylinders or placing them in a crate.
Germany: Künstliche Luft zur medizinischen
• Protect from sunlight. Store in a well
Anwendung SOL
ventilated room that is intended exclusively
for storage of medicinal gases.
Luxemburg: Air synthétique médicinal SOL
• Keep away from combustible materials.
The Netherlands: Lucht synthetisch
• Gas cylinders containing different type of gas medicinaal SOL
or composition should be stored separately.
United Kingdom: Medicinal air synthetic
• Full and empty gas cylinders should be
stored separately.
This leaflet was last revised in 06/2015.
• Gas cylinders must not be stored close to
sources of heat.
• Store cylinders under cover and protected
against the effects of weather.
• Close valves of gas cylinders after use.
• Return gas cylinders to supplier when empty.
4. Possible side effects
There are no known side effects.

6. Contents of the pack and other
information
What Medicinal air synthetic contains
The active substance is oxygen 21.75% v/v
The other ingredient is nitrogen
What Medicinal air synthetic looks like and
contents of the pack
• Medicinal air synthetic is an inhalation gas.
The gas is colourless, odourless and
tasteless.
• Medicinal air synthetic is stored in gas
cylinders under the pressure of 200 bar (at
15°C).
• The cylinders are made of steel or aluminium.
The valves are made of brass, steel or
aluminium.
• The shoulder of the cylinder is colour-coded
in black and white. The colour of the cylinder
body is white.
• The gas cylinders, valves and valve outlets
conform to relevant EU standards.
• Gas cylinders with a capacity of (x) litres
supply (y) litres of air at 15°C and 1 Bar as
follows:
Content in litres (x)
Number of litres of air (y)
Content in litres (x)
Number of litres of air (y)

1

2

3

5

10

20

30

40

196

393

589

982

1956

3929

5894

7858

50

8x40

8x50

12x40

12x50

16x40

16x50

20x50

9823

62867

78584

94301

117876

125735

157168

196460

Not all pack sizes may be marketed.

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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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