Aire Medicinal Sintetico Carburos Metalicos, 22% v/v, medicinal gas, compressed

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carburos Metálicos Synthetic Medicinal Air, 22% v/v, compressed medicinal gas

Oxygen

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Carburos Metálicos Synthetic Medicinal Air is and what it is used for
2. What you need to know before using Carburos Metálicos Synthetic Medicinal Air
3. How to use Carburos Metálicos Synthetic Medicinal Air
4. Possible side effects
5. How to store Carburos Metálicos Synthetic Medicinal Air
6. Contents of the pack and other information

1. What Medicinal Synthetic Air Carburos Metálicos is and what it is used for

Medicinal air is an inhalation gas belonging to the group of medicinal gases.

Medicinal air is used to prevent oxygen deficiency.

2. What you need to know before starting to use Metal Carbides Synthetic Medicinal Air

Do not use Metal Carbides Synthetic Medicinal Air

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

Warnings and precautions

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

Use of Metal Carbides Synthetic Medicinal Air with other medicines

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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy and breastfeeding

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

Medicinal Air can be used during pregnancy and breastfeeding.

Driving and using machines

Medicinal Air does not affect the ability to drive or operate machinery.

3. How to use Synthetic Medicinal Air Carburos Metálicos

Follow exactly the administration instructions for Medicinal Air 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 are using medicinal air.

How to use Synthetic Medicinal Air Carburos Metálicos

If you need to use Medicinal Air for an extended period of time, it is recommended that the Medicinal Air be humidified.

Medicinal Air is an inhalation gas administered via the air inhaled through a special device, such as a nasal cannula or a face mask, a mask secured around the head, or a tube inserted into the trachea (tracheostomy). The device must be used as described by the manufacturer. Excess oxygen is eliminated from the body through exhalation and mixes with the surrounding air. During anesthesia, a special apparatus with rebreathing or recycling systems may be used so that exhaled air is inhaled again (a "rebreathing" system). If you are unable to breathe independently, medicinal air may be administered via a ventilator.

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

• The gas cylinder must not be used if it is visibly damaged or if damage is suspected, or if it has been exposed to extreme temperatures.
• Any contact with oil, grease, or other hydrocarbons must be avoided.
• Only equipment suitable for the specific type of gas and gas cylinder should be used.
• To avoid the risk of injury, pliers or other tools must not be used to open or close the cylinder valve.
• The container must not be modified in shape.
• In case of leakage, close the cylinder valve immediately, provided it is safe to do so. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow the oxygen to vent safely.
• Close the valves of empty gas cylinders.
• Tubing connections, 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 thoroughly.
• Siphoning of pressurized gas is not permitted.
• Smoking or bringing open flames near the gas cylinder is strictly prohibited.

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

There are no known risks of overdose with Medicinal Air.

Administration of Medicinal Air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may occur when transitioning from high pressure to normal pressure and may cause headaches, dizziness, nausea, confusion, sometimes paralysis and unconsciousness (and even death).

If you forget to use Synthetic Medicinal Air Carburos Metálicos

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

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

4. Possible adverse effects

No adverse effects are known.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Synthetic Air Carburos Metálicos

Keep out of the reach and sight of children.

Do not use Medicinal Air after the expiry date stated on the gas cylinder after EXP. The expiry date refers to the last day of the month indicated.

The following safety instructions must be observed when storing gas cylinders:

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

6. Contents of the container and other information

Composition of Synthetic Medicinal Air Carburos Metálicos

The active substance is oxygen 22% v/v.

The other component is nitrogen.

Appearance of the product and contents of the container

Pharmaceutical form and packaging:

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

Some pack sizes may not 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 (Biscay)

Spain

Carburos Metálicos – Alcalá de Guadaira

Carretera de Sevilla a Granada, Km 9.6 – Polígono Industrial La Red

41500 Alcalá de Guadaira (Seville)

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 (Balearic Islands)

Spain

Carburos Metálicos – Telde

C/ El Pescador, 21

Poligono Industrial Salinetas

35219 - Telde (Canary Islands)

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 European Economic Area member states 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 Patient Information Leaflet was last approved in August 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/