SYNTHETIC MEDICAL AIR METAL CARBIDES, 22% V/V, MEDICAL GAS, COMPRESSED

2. What you need to know before starting to use Medicinal Synthetic Air Carburos Metálicos

Do not use Medicinal Synthetic Air Carburos Metálicos

There are no known situations in which medicinal air should not be used.

Warnings and precautions

• Before starting treatment with Medicinal Air, ensure that it is administered at atmospheric pressure.
• Administration of Medicinal Air under pressure can cause decompression sickness and oxygen toxicity. Decompression sickness can occur during the transition from excess pressure to normal pressure and can cause headaches, dizziness, nausea, confusion, sometimes paralysis, and unconsciousness (even death).
• If Medicinal Air is mixed with other inhalation gases, the gas mixture should always contain sufficient oxygen (at least 22% v/v). Consequently, mixtures of Medicinal Air with other gases should always include additional oxygen from other sources.
• If you administer medicinal air at high flow rates, it may feel cold to the touch.

Using Medicinal Synthetic Air Carburos Metálicos with other medications

It is not expected that Medicinal Air will have effects on other medications. Interactions of 100% v/v oxygen with other medications are known. Consult your doctor or pharmacist if you have doubts.

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

Pregnancy and breastfeeding

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

Medicinal air can be used during pregnancy and breastfeeding.

Driving and using machines

Medicinal air does not affect the ability to drive or use machines.

3. How to use Medicinal Synthetic Air Carburos Metálicos

Follow the administration instructions for Medicinal Air exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose will vary depending on the circumstances for which you use the medicinal air.

How to use Medicinal Synthetic Air Carburos Metálicos

If you need to use Medicinal Air for a prolonged period, it is recommended that Medicinal Air be humidified.

Medicinal air is an inhalation gas that is administered through the inhaled air by means of special equipment, such as a nasal catheter or a face mask, with a mask that fits around the head or with a tube in the trachea (tracheotomy). The device should be used as described by the manufacturer. The excess oxygen leaves the body through exhalation and mixes with the ambient air. During anesthesia, special equipment with rebreathing or recycling systems is used so that the exhaled air is inhaled again (a "rebreathing" system). If you are unable to breathe on your own, you may be given medicinal air through a ventilation machine.

Follow the provider's instructions, especially regarding the following points:

• The gas cylinder cannot be used if it is visibly damaged or if it is suspected to have been damaged or exposed to extreme temperatures.
• Any contact with oil, grease, or other hydrocarbons should be avoided.
• Only suitable equipment for the specific type of gas and gas cylinder should be used.
• To avoid the risk of damage, pliers or other tools should not be used to open or close the cylinder valve.
• The container should not be modified.
• In case of a leak, the cylinder valve should be closed immediately, as long as it is safe to do so. If the valve cannot be closed, the cylinder should be moved to a safe outdoor location to discharge the oxygen.
• The valves of empty gas cylinders should be closed.
• Tube connections, valves, etc. should be clean and dry, and when dirty, should be cleaned according to the provider's instructions. Do not use solvents. Use a clean, lint-free cloth, and dry the equipment.
• Siphoning gas under pressure is not permitted.
• Smoking or bringing open flames near the gas cylinder is not allowed.

If you use more Medicinal Synthetic Air Carburos Metálicos than you should

There are no known risks of overdose with Medicinal Air.

Administration of Medicinal Air under pressure can cause decompression sickness and oxygen toxicity. Decompression sickness can occur during the transition from excess pressure to normal pressure and can cause headaches, dizziness, nausea, confusion, sometimes paralysis, and unconsciousness (even death).

If you forget to use Medicinal Synthetic Air Carburos Metálicos

Use the medicinal air as soon as you remember. Do not take a double dose of Medicinal Synthetic Air Carburos Metálicos to make up for forgotten doses.

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

4. Possible side effects

No side effects are known.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Medicinal Synthetic Air Carburos Metálicos

Keep out of the reach and sight of children.

Do not use Medicinal Air after the expiration date shown on the gas cylinder after CAD. The expiration date is the last day of the month indicated.

During storage of gas cylinders, the following safety rules should be followed:

• Store between –20 °C and +65 °C.
• Keep containers in a vertical position.
• Store in a well-ventilated area.
• Keep away from flammable products.
• Protect from falls and other impacts.
• Cylinders containing a different type of gas should be stored separately.
• Full and empty gas cylinders should be stored separately.
• Store under cover and well protected from adverse weather conditions.
• Close the valves of the cylinders.
• Return the cylinder to the supplier when it is empty.

6. Package contents and additional information

Composition of Medicinal Synthetic Air Carburos Metálicos

The active principle is oxygen 22% v/v.

The other component is nitrogen.

Appearance of the product and package contents

Pharmaceutical form and packaging:

• Medicinal Synthetic Air Carburos Metálicos is a compressed medicinal gas, colorless, odorless, and tasteless.
• Medicinal Synthetic Air Carburos Metálicos is stored under pressure in gas cylinders. The body of the cylinder is white and the shoulder has a black band on a white background.
• Gas cylinders with a capacity of x liters provide y (unit of volume) of Medicinal Synthetic Air Carburos Metálicos at 15 °C and 1 bar.

Some package sizes may only be marketed.

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 Industrial La 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 medication 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, 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:Aire medicinal sintético Carburos Metálicos, 22% v/v, gas medicinal, comprimido

This leaflet was approved inAugust 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/