Medical synthetic air air products

Package leaflet: Information for the user

Synthetic Medical Air Air Products, 22% (v/v), compressed medical gas
Oxygen
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Synthetic Medical Air Air Products is and what it is used for
2. Important information before use of Synthetic Medical Air Air Products
3. How to use Synthetic Medical Air Air Products
4. Possible side effects
5. How to store Synthetic Medical Air Air Products
6. Contents of the pack and other information

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

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

2. Important information before use of Synthetic Medical Air Air Products

When not to use Synthetic Medical Air Air Products
There are no known situations in which medical air should not be used.

Warnings and precautions

• Before starting treatment with medical air, ensure that it is administered at atmospheric pressure.
• Administration of medical air under pressure may cause decompression sickness and oxygen toxicity. Transitioning from high-pressure conditions to normal atmospheric pressure may result in decompression sickness, which can cause headache, dizziness, nausea, disorientation, and in some cases paralysis, loss of consciousness (or even death).
• When medical air is mixed with other inhalation gases, the gas mixture must always contain sufficient oxygen concentration (at least 22% v/v). Therefore, mixtures of medical air with other gases must always include additional oxygen from other sources.
• When medical air is administered at high flow rates, it may be perceived as cold.

Synthetic Medical Air Air Products and other medicines
Medical air is not expected to affect other medicines. Interactions of 100% v/v oxygen with other drugs are known. If in doubt, consult your doctor or pharmacist.
Inform your doctor or pharmacist about all medicines you have recently taken, are currently taking, or may start taking.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicinal product.
Medical air may be used during pregnancy and breastfeeding.

Driving and operating machinery
Medical air has no effect on the ability to drive or operate machinery.

3. How to use Synthetic Medical Air Air Products

Always use this medicinal product exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The dosage depends on the circumstances of medical air use.

How to use Synthetic Medical Air Air Products
If prolonged use of medical air is required, humidification is recommended.
Medical air is an inhalation gas administered via inhaled air delivered using special equipment such as a nasal cannula or face mask with a head strap, or via an endotracheal tube (tracheostomy). The equipment must be operated according to the manufacturer's instructions. Excess oxygen is eliminated from the body through exhalation and mixes with ambient air. During anesthesia, special equipment with an absorption or rebreathing system is used, allowing re-inhalation of exhaled air (a "rebreathing" system). If spontaneous breathing is not possible, medical air may be administered via a ventilator.

Follow the supplier's instructions, especially regarding the following:

• Gas cylinders must not be used if visibly damaged or suspected of being damaged, or if exposed to extreme temperatures.
• Avoid contact with oils, greases, and other hydrocarbons.
• Use only equipment suitable for the specific type of gas cylinder and gas.
• Do not use pliers or other tools to open or close the cylinder valve, to avoid risk of damage.
• Do not alter the shape of the container.
• If safe, close the cylinder valve in case of leakage. If the valve cannot be closed, leave the cylinder to empty in a safe outdoor location.
• Valves of empty gas cylinders must be closed.
• Flexible hose connectors, valves, etc., must be clean and dry. If contaminated, clean them according to the supplier's instructions. Do not use solvents. Use a clean, lint-free cloth for cleaning and drying equipment.
• Siphoning gas under pressure is prohibited.
• Smoking or using open flames near gas cylinders is prohibited.

Use of a higher than recommended dose of Synthetic Medical Air Air Products
There are no known risks associated with overdosing on medical air.
However, administration of medical air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may also occur during transition from high-pressure to normal atmospheric conditions and may cause headache, dizziness, nausea, disorientation, and in some cases paralysis and loss of consciousness (or even death).

Interrupting treatment with Synthetic Medical Air Air Products
If a dose of medical air is missed, administer it as soon as you remember.
Do not use a double dose of synthetic medical air to make up for a missed dose.

If you have any questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

No known adverse effects.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting of adverse effects helps to provide more information on the safety of the medicinal product.

5. How to store Powietrze medyczne syntetyczne Air Products
The medicinal product should be stored out of sight and reach of children.
Do not use Powietrze medyczne syntetyczne Air Products after the expiry date stated on the gas cylinder label following the abbreviation "EXP".
When storing the gas cylinder, the following safety rules must be observed:

• Store at temperatures between -20°C and +65°C.
• Store in an upright position.
• Store in a well-ventilated area.
• Keep away from flammable materials.
• Protect from falling and other impacts.
• Gas cylinders containing other types of gas must be stored separately.
• Full and empty gas cylinders must be stored separately.
• Store covered and well protected from weather conditions.
• Close cylinder valves.
• After emptying the cylinder, return it to the supplier.

6. Contents of the packaging and other information

What Powietrze medyczne syntetyczne Air Products contains

• The active substance is oxygen 22% (v/v).
• The other component is nitrogen.

What Powietrze medyczne syntetyczne Air Products looks like and contents of the packaging
Pharmaceutical form and packaging:

• Compressed Powietrze medyczne syntetyczne Air Products is a colourless, odourless and tasteless gas for medical use. Powietrze medyczne syntetyczne Air Products is stored under pressure in gas cylinders.
• The valves are made of brass. The cylinder body is white with a black band on a white background at the shoulder.
• Gas cylinders with a capacity of x litres contain y (unit of volume) of Powietrze medyczne syntetyczne Air Products at a temperature of 15°C and a pressure of 1 bar.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Air Products Sp. z o.o.
ul. Komitetu Obrony Robotników 48
02-146 Warsaw
Poland
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 authorised for sale in 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