Povietzhe medihne sintetihne Air Products

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Medical synthetic air Air Products, 22% (v/v), compressed medical gas

Oxygen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Medical Synthetic Air Air Products and what is it used for
• 2. Important information before using Medical Synthetic Air Air Products
• 3. How to use Medical Synthetic Air Air Products
• 4. Possible side effects
• 5. How to store Medical Synthetic Air Air Products
• 6. Package contents and other information

1. What is Medical Synthetic Air Air Products and what is it used for

Medical air is an inhalation gas belonging to the group of medical gases.
Medical air is used to prevent oxygen deficiency in the body.

2. Important information before using Medical Synthetic Air Air Products

Products

When not to use Medical Synthetic Air Air Products

There are no known situations in which medical air cannot be used.

Warnings and precautions

• Before starting treatment with medical air, you should ensure that it is administered at atmospheric pressure.
• Administering medical air under pressure can cause decompression sickness and oxygen poisoning. During the transition from high-pressure mode to normal pressure mode, decompression sickness may occur, which can cause headache, dizziness, nausea, disorientation, and sometimes paralysis and loss of consciousness (even death).
• In the case of a mixture of medical air with other inhalation gases, the mixture must always contain a sufficient concentration of oxygen (at least 22% v/v). Therefore, mixtures of medical air with other gases must always contain additional oxygen from other sources.
• When administering medical air with a high flow rate, it may feel cool.

Medical Synthetic Air Air Products and other medicines

Medical air should not interact with other medicines. It is known that 100% v/v oxygen interacts with other medicines. In case of doubts, you should consult a doctor or pharmacist.
You should inform your doctor or pharmacist about all the medicines you have taken recently, as well as the medicines you are currently taking, and any medicines you may start taking.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Medical air can be used during pregnancy and breastfeeding.

Driving and using machines

Medical air does not affect the ability to drive and use machines.

3. How to use Medical Synthetic Air Air Products

The medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The dose depends on the circumstances of using medical air.

How to use Medical Synthetic Air Air Products

In case it is necessary to use medical air for a longer period, it is recommended to humidify it.
Medical air is an inhalation gas that is administered through inhaled air using special equipment, such as a nasal catheter or face mask, with a hood fitted to the head or with a tracheal tube (tracheotomy). The device must be operated in accordance with the manufacturer's instructions. Excess oxygen is removed from the body through exhalation and mixes with the surrounding air. During anesthesia, a special device with a absorption or recirculation system is used, which allows for the re-inhalation of exhaled air (a "rebreathing" system). If the patient is unable to breathe on their own, medical air can be administered through a respirator.
You should follow the supplier's instructions, especially with regard to the following:

• Cylinders with gas cannot be used if they are visibly damaged or if there is a suspicion of damage, or if they are used at extreme temperatures.
• You should avoid contact with oils, greases, and other hydrocarbons.
• Only equipment suitable for the specific type of gas cylinder and gas can be used.
• Pliers or other tools should not be used to open and close the cylinder valve to avoid the risk of damage.
• The shape of the container should not be changed.
• If it is safe to do so, in case of a leak, the cylinder valve should be closed. If the valve cannot be closed, the cylinder should be left to empty in a safe place outside.
• The valves of empty gas cylinders must be closed.
• The connections of flexible tubes, valves, etc. must be clean and dry, and if contaminated, they should be cleaned according to the supplier's instructions. Solvents should not be used. A clean, lint-free cloth should be used for cleaning and drying the equipment.
• Pressurized gas siphoning is prohibited.
• Smoking or using open fire is not allowed near gas cylinders.

Using a higher dose of Medical Synthetic Air Air Products than recommended

There are no known risks associated with overdosing on medical air.
Administering medical air under pressure can cause decompression sickness and oxygen poisoning. Decompression sickness may also occur during the transition from high-pressure mode to normal pressure mode, which can cause headache, dizziness, nausea, disorientation, and sometimes paralysis and loss of consciousness (even death).

Stopping the use of Medical Synthetic Air Air Products

The dose of medical air should be taken immediately after realizing it was missed.
A double dose of synthetic medical air should not be used to make up for a missed dose.
In case of any questions about using this product, you should consult a doctor or pharmacist.

4. Possible side effects

There are no known side effects.

Reporting side effects

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Medical Synthetic Air Air Products

The medicine should be stored in a place that is out of sight and reach of children.
Do not use Medical Synthetic Air Air Products after the expiry date stated on the label of the gas cylinder after the abbreviation "EXP".
When storing the gas cylinder, the following safety rules should be observed:

• Store at a temperature between -20°C and +65°C.
• Store in an upright position.
• Store in a well-ventilated room.
• Store away from flammable products.
• Protect against falling and other impacts.
• Cylinders containing a different type of gas should be stored separately.
• Full and empty gas cylinders should be stored separately.
• Store covered and well-protected from the weather.
• Close the cylinder valves.
• After emptying the cylinder, return it to the supplier.

6. Package contents and other information

What Medical Synthetic Air Air Products contains

• The active substance of the medicine is oxygen 22% (v/v).
• The other ingredient is nitrogen.

What Medical Synthetic Air Air Products looks like and what the package contains

Pharmaceutical form and packaging:

• Compressed Medical Synthetic Air Air Products is a colorless, odorless, and tasteless gas for medical use. Medical Synthetic Air Air Products is stored under pressure in gas cylinders.
• The valves are made of brass. The body of the cylinder is white, and the shoulder has a black band on a white background.
• Cylinders with a capacity of x liters contain y (volume unit) of Medical Synthetic Air Air Products at a temperature of 15°C and a pressure of 1 bar.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Air Products Sp. z o.o.
ul. Komitetu Obrony Robotników 48
02-146 Warsaw

Manufacturer:

Air Products
Zone Industrielle de l’Epinoy
59175 Templemars
France
Sociedad Española De Caburos Metálicos S.A.
Barrio Chaco n/v
48480 Arrigorriaga (Vizcaya)
Spain
Sociedad Española De Caburos Metálicos S.A.
Carretera de Sevilla a Granada, Km 9.6 – Polígono Industrial La Red
41500 Alcala de Guadaira (Sevilla)
Spain
Sociedad Española De Caburos Metálicos S.A.
Ildefonso Carrascosa, Parcela 20-21 – Polígono Industrial Mediterráneo
46560 Massalfassar (Valencia)
Spain
Sociedad Española De Caburos Metálicos S.A.
C/ El Pescador, 21 – Poligono Industrial Salinetas

• 35219 - Telde (Las Palmas) Spain

Sociedad Española De Caburos Metálicos S.A.
C/ Celleters, 142 – Polígono Industrial Can Rubiol

• 07141 – Marratxi (Baleares) Spain

Gasin II Gases Industriais Unipessoal Lda.
Rua do Progresso, 53, Perafita

• 4451 – 801 Leça da Palmeira Portugal

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Belgium:Lucht, Synthetisch medicinaal AIR PRODUCTS, 22%V/V; medicinaal gas, samgeperst
Netherlands:Lucht medicinaal synthetisch AIR PRODUCTS, 22%V/V, medicinaal gas, samengeperst
Czech Republic:Vzduch medicinální syntetický Air Products 22% V/V, medicinální plyn, stlačený
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

Date of last update of the leaflet: