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AIR MEDICINAL SYNTHETIC AIR PRODUCTS 22% V/V MEDICINAL GAS COMPRESSED

Active substance(s): OXYGEN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Air Medicinal synthetic AIR PRODUCTS, 22%v/v,
medicinal gas, compressed
Active substance : Oxygen

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 Air Medicinal 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 after 14 days.



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.

1

Air Medicinal is an inhalation gas and belongs to the
group of medical gases.
Air Medicinal is used to prevent oxygen deficit.

2

There are no known situations in which Air Medicinal
may not be used.
Take special care with Air Medicinal synthetic
AIR PRODUCTS



In this leaflet:

2. Before you use Air Medicinal synthetic
AIR PRODUCTS
3. Possible side effects
4. How to store Air Medicinal synthetic
AIR PRODUCTS
5. Further information

Before you use Air Medicinal synthetic
AIR PRODUCTS

Do not use Air Medicinal synthetic Air Products



1. What Air Medicinal synthetic AIR PRODUCTS
is and what it is used forBefore you use Air
Medicinal

What Air Medicinal synthetic AIR
PRODUCTS is and what it is used for



Air Medicinal is a gas for inhalation that is
administered through inhaled air using special
equipment, such as a nose catheter or a facial mask,
with a cover that fits around the head, or a tube to the
trachea (tracheotomy). The device must be operated
as described by the manufacturer. Any excess
oxygen leaves your body through breathing out
and mixes with the ambient air. During anaesthesia,
special equipment with rebreathing or recycling
systems is used so that the exhaled air is inhaled
once again (a “rebreathing” system). If you cannot
breathe independently you may receive Air Medicinal
via a ventilator machine.

Possible side effects

There are no known side effects.

5

How to store Air Medicinal

Keep out of the reach and sight of children.
Do not use Air Medicinal after the expiry date which is
stated on the gas cylinder after EXP.
The following safety regulations must be adhered to
during storage of the gas cylinders:


Store between – 20°C and + 65°C.



Store in vertical position.



Store in a well ventilated room.



Keep away from inflammable products.

Gas cylinders – Filling pressure 200bar,
Air Medicinal
Volume (x) in
litres

No of litres air
(y)

0.5

97

1

193

2

387

3

580

4

774

5

967

7

1354

10

1935

13

2515

15

2902

20

3869

25

4836
5804
7738

Follow your supplier’s instructions, especially as
regards the following:

The administration of Air Medicinal under
pressure may cause caisson disease and oxygen
toxicity. Caisson disease may occur during
the transition from over-pressure to normal
pressure and may cause headache, dizziness,
nausea, confusion, sometimes paralysis and
unconsciousness (and even death).



The gas cylinder cannot be used if it is visibly
damaged or is suspected of having been
damaged or exposed to extreme temperatures.



Protect from falling and other impacts.

30



Cylinders containing a different type of gas
should be stored separately.

40



All contact with oil, grease or other hydrocarbons
must be avoided.



Full and empty gas cylinders should be stored
separately.

50

9673

800

154768



Only equipment suitable for the specific type of
gas cylinder and gas may be used.



Store covered and well-protected against the
effects of the weather.

(16x50 l)



No pliers or other tools may be used to open or
close the cylinder valve, to prevent the risk of
damage.



Close the valves of the cylinders.



Return the cylinder to the supplier when empty

(18x50 l)

If Air Medicinal is mixed with other inhalational
gases, sufficient oxygen (at least 22% v/v) must
always be present in this gas mixture. Therefore
mixtures of Air Medicinal with other gases must
always include additional oxygen from other
sources.



The shape of the container must not be altered.



In the event of a leak, the cylinder valve must
be closed immediately, if it is safe to do so. If
the valve cannot be closed, the cylinder must be
taken to a safe place out of doors to allow the
oxygen to flow out.

If you administer Air Medicinal at high flow rates,
it may feel cold to the touch.

Air Medicinal is not expected to have an effect on
other medicines. Interactions of 100% v/v oxygen
with other medicines are known. You should check
with your doctor or pharmacist if you are not sure.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Air Medicinal may be used during pregnancy and
breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Air Medicinal does not affect your ability to drive or
operate machines.

How to use Air Medicinal synthetic
AIR PRODUCTS

Dosage

UK PIL APRIL 2012.indd 1

If you have to use Air Medicinal for a longer period
of time, it is recommended that Air Medicinal is
humidified.

4

Before treatment with Air Medicinal, make sure
that it is administered at atmospheric pressure.

Using other medicines

3

How to use Air Medicinal



The valves of empty gas cylinders must be
closed.



Connections for hoses, valves etc. must be
clean and dry and, when dirty, should be cleaned
according to the supplier’s instructions. Do not
use any solvents. Use a clean, lint-free cloth to
clean and dry the equipment.



The siphoning of gas under pressure is not
permitted.



Smoking or naked flames are not permitted near
a gas cylinder.

6

The administration of Air Medicinal under pressure
may cause caisson disease and oxygen toxicity.
Caisson disease may occur during the transition from
over-pressure to normal pressure and may cause
headache, dizziness, nausea, confusion, sometimes
paralysis and unconsciousness (and even death).

174114

Not all pack sizes may be marked.

Further information

What Air Medicinal synthetic AIR PRODUCTS
contains


The active substance is oxygen 22% v/v.



The other ingredient is nitrogen.

What Air Medicinal synthetic AIR PRODUCTS
looks like and contents of the pack
Pharmaceutical form and package:


Air Medicinal synthetic AIR PRODUCTS is a
colourless, odourless and tasteless medicinal
gas, compressed.



Air Medicinal synthetic AIR PRODUCTS is stored
under pressure in gas cylinders. The colour of
the cylinder body is white and for the shoulder is
blackband on white.



Gas cylinders with a capacity of x litres provide
y (unit of volume) Air Medicinal synthetic AIR
PRODUCTS at 15°C and 1 bar.

If you use more Air Medicinal than you should
There are no known risks of overdose of Air
Medicinal.

900

If you forget to use Air Medicinal

The dosage will vary depending on the the
circumstances in which you are using Air Medicinal.

Use Air Medicinal as soon as you remember. Do not
use a double dose of Air Medicinal synthetic to make
up for a forgotten dose.

You should check with your doctor or pharmacist if
you are not sure.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

05/04/2012 15:48:46

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

This medicinal product is authorised in the
Member States of the EEA under the following
names:

Air Products PLC
Millennium Gate 2, Westmere Drive, Crewe,
Cheshire, CW1 6AP
United Kingdom
Tel.: +44 1270 614 779
Fax: +44 1270 614 050

Belgium: Lucht, Synthetisch medicinaal AIR
PRODUCTS, 22%v/v; medicinaal gas, samengeperst

Manufacturer:

Czech Republic: Vzduch medicinální syntetický Air
Products 22% v/v, medicinální plyn, stlačený

Air Products S.A.S.
Zone Industrielle de l’Epinoy
59175 Templemars
France
Tel : +33 3 206 205 17
Carburos Metálicos – Arrigorriaga
Barrio Chaco n/v
48480 Arrigorriaga (Vizcaya)
Spain
Tel : +34 946 71 92 00
Carburos Metálicos – Alcalá de Guadaira
Carretera de Sevilla a Granada,Km 9.6 – Polígono
Industrial La Red
41500 Alcala de Guadaira (Sevilla)
Spain
Tel : +34 955 63 15 90
Carburos Metálicos – Massalfassar
Ildefonso Carrascosa, Parcela 20-21 - Polígono
Industrial Mediterráneo
46560 Massalfassar (Valencia)
Spain
Tel : +34 96 140 13 54

UK PIL APRIL 2012.indd 2

The Netherlands: Lucht medicinaal synthetisch AIR
PRODUCTS, 22%v/v, medicinaal gas, samengeperst

Germany: Künstliche Luft zur medizinischen
Anwendung Air Products 22 % v/v Gas zur
medizinischen Anwendung, druckverdichtet
Portugal: Ar medicinal Sintético Gasin, 22%v/v, gás
medicinal, comprimido
Spain: Aire medicinal sintetico Carburos Metálicos,
22%v/v, gas medicinal, comprimido
United Kingdom: Air Medicinal synthetic Air
Products, 22% v/v, medicinal gas, compressed
This leaflet was last approved in 02/2012.


05/04/2012 15:48:46

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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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