Prospect: information for the user

Synthetic Medical Air, Metallic Carbides, 22% v/v, medicinal gas, compressed

Oxygen

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What it isand what it is used for

2. What you need to know before starting to useSynthetic Medical Air, Metallic Carbides

3. How to useSynthetic Medical Air, Metallic Carbides

4. Possibleadverse effects

5. Storage ofSynthetic Medical Air, Metallic Carbides

6. Contents of the packageand additional information

Medical airis an inhalation gas that belongs to thegroup of medical gases.

Medical airis used to prevent oxygen deficiency.

Do not use Synthetic Metallic Carbon Air

No situations are known in whichthe medicinal airshould not be used.

Warnings and precautions

-Before starting treatment withSynthetic Metallic Carbon Air, ensure that it is administered at atmospheric pressure.

-The administration of Synthetic Metallic Carbon Air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may occur during the transition from excessive pressure to normal pressure and may cause headaches, dizziness, nausea, confusion, sometimes paralysis and unconsciousness (and even death).

-If Synthetic Metallic Carbon Air is mixed with othergases for inhalation, in the gas mixture there must always be sufficient presence of oxygen (at least 22% v/v). Consequently, mixtures of Synthetic Metallic Carbon Air with other gases must always include additional oxygen from other sources.

- If you administerSynthetic Metallic Carbon Air at high flow rates, you may feel cold to the touch.

Use of Synthetic Metallic Carbon Air with other medications

No interactions are expected between Synthetic Metallic Carbon Air and other medications. Known interactions of 100% oxygen v/v with other medications exist. Consult your doctor or pharmacist if you have doubts.

Inform your doctor or pharmacist if you are using or have used recently or may have to use other medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before inhaling this medication

Synthetic Metallic Carbon Air can be used during pregnancy and breastfeeding.

Driving and operating machinery

Synthetic Metallic Carbon Airdoes not affect the ability to drive or operate machinery.

Follow exactly the administration instructions for Medical Air indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose will vary according to the circumstances for which you use Medical Air.

How to use Medical Air synthetic Carburos Metálicos

If you must use Medical Air for a prolonged period, it is recommended that Medical Air be humidified.

Medical Air is an inhalation gas that is administered through the air inhaled by means of a special device, such as a nasal catheter or a facial mask, with a mask that fits around the head or with a tube in the trachea (tracheotomy).The device must be used as described by the manufacturer.The excess oxygen is exhaled from the body through exhalation and mixes with the ambient air.During anesthesia, a special device with respiration or recycling systems is used so that the exhaled air is inhaled again (arespiration system). If you cannot breathe autonomously, you may be administered Medical Air through a ventilation machine.

Follow the supplier's instructions, especially those related to the following points:

• The gas bottle cannot be used if it is visibly damaged or if it is suspected to have been damaged or exposed to extreme temperatures.
• Avoid any contact with oil, grease, or other hydrocarbons.
• Only use equipment suitable for the specific type of gas and gas bottle.
• To avoid the risk of damage, do not use pliers or other tools to open or close the valve on the bottle.
• Do not modify the shape of the container.
• In case of a leak, immediately close the valve on the bottle, if it is safe to do so.If the valve cannot be closed, the bottle must be moved to a safe outdoor location to discharge the oxygen.
• Close the valves on empty gas bottles.
• The connections for tubes, valves, etc. must be clean and dry and, when dirty, must be cleaned according to the supplier's instructions.Do not use solvents.Use a clean, lint-free cloth and dry the equipment.
• It is not permitted to siphon gas under pressure.
• It is not permitted to smoke or bring open flames near the gas bottle.

If you use more Medical Air synthetic Carburos Metálicos than you should

No known risks of overdose are associated with Medical Air.

The administration of Medical Air under pressure may cause decompression sickness and oxygen toxicity.Decompression sickness may occur during the transition from high pressure to normal pressure and may cause headaches, dizziness, nausea, confusion, sometimes paralysis and unconsciousness (and even death).

If you forgot to useMedical Air synthetic Carburos Metálicos

Use Medical Air as soon as you remember.Do not take a double dose of Medical Air to compensate for the missed doses.

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

No adverse effects are known.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep out of reach and sight of children.

Do not use Medical Air after the expiration date that appears on the gas bottle after CAD.The expiration date is the last day of the month indicated.

During the storage of gas bottles, the following safety standards must be followed:

• Store between –20 °C and +65 °C.
• Keep containers in an upright position.
• Store in a well-ventilated area.
• Keep away from flammable products.
• Protect from falls and other impacts.
• Gas bottles containing a different type of gas must be stored separately.
• Full and empty gas bottles must be stored separately.
• Store covered and well-protected from adverse atmospheric conditions.
• Close the valves on the bottles.
• Return the empty bottle to the supplier.

Composition of Synthetic Medical Air Carburos Metálicos

The active ingredient is oxygen 22% v/v.

The other component is nitrogen.

Aspect of the product and packaging content

Pharmaceutical form and packaging:

• Synthetic Medical Air Carburos Metálicosis a medicinal gas, compressed, colorless, odorless, and tasteless.
• Synthetic Medical Air Carburos Metálicosis stored under pressure in gas bottles. The bottle body is white and the nozzle has a black band on a white background.
• Gas bottles with a capacity of x liters provide and (unit of volume) ofSynthetic Medical Air Carburos Metálicosat15 °Cand 1 bar.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

S.E. DE CARBUROS METÁLICOS, S.A.

Avda de la Fama, 1

08940 – Cornella de Llobregat

Spain

Manufacturer:

Air Products S.A.S.

Zone Industrielle de l’Epinoy

59175 Templemars

France

Carburos Metálicos – Arrigorriaga

Barrio Chaco n/v

48480 Arrigorriaga (Vizcaya)

Spain

Carburos Metálicos – Alcalá de Guadaira

Carretera de Sevilla a Granada,Km 9.6 – Polígono IndustrialLa Red

41500 Alcala de Guadaira (Sevilla)

Spain

Carburos Metálicos – Massalfassar

Ildefonso Carrascosa, Parcela 20-21 - Polígono Industrial Mediterráneo

46560 Massalfassar (Valencia)

Spain

Carburos Metálicos – Marratxi

C/ Calleters, 142

Polígono Industrial Can Rubiol

07141 – Marratxi (Islas Baleares)

Spain

Carburos Metálicos – Telde

C/ El Pescador, 21

Poligono Industrial Salinetas

35219 - Telde (Islas Canarias)

Spain

GASIN II - Gases Industriais, Unipessoal Lda

Rua do Progresso, 53

4451-801 Perafita (Leça de Palmeira)

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

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

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

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

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:Synthetic Medical Air Carburos Metálicos, 22% v/v, gas medicinal, comprimido

This leaflet was approved inAugust 2020

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/