Leaflet: information for the user

Medical Nitrogen Oxide Nippon Gases, 98%,medical liquefied gas in a fixed cryogenic container

Nitrous Oxide

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed only for 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 any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isMedical Nitrogen Oxide Nippon Gasesand what it is used for

2. What you need to know before starting to useMedical Nitrogen Oxide Nippon Gases

3. How to useMedical Nitrogen Oxide Nippon Gases

4. Possible adverse effects

5. Storage ofMedical Nitrogen Oxide Nippon Gases

6. Contents of the pack and additional information

Medical Nitrous Oxide Nippon Gasesbelongs to a group of medications called general anesthetics.

This medication is indicated for:

• Adjunct to general anesthesia, in association with all anesthetic agents administered via intravenous or inhalation routes.

Adjunct to analgesia in the operating room or delivery room.

Do not use Medical Nitrous Oxide Nippon Gases

If you need pure oxygen ventilation

In patients with intraocular gas injection (e.g. SF6, C3F8, C2F6)

If you have an undrained air embolism, especially intracranial or pneumothorax (air in pleural cavity), bullous emphysema (obstructive bronchitis)

It should not be administered for a period exceeding 24 hours

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Medical Nitrous Oxide Nippon Gases

Caution is recommended in patients with heart failure and in patients who have undergone surgery of the breasts and inner ear.

Other medications and Medical Nitrous Oxide Nippon Gases:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medical nitrous oxide potentiates the hypnotic effects of intravenous or inhalation anesthetics (thiopental, benzodiazepines, morphines, halogenated).

The combined use of medical nitrous oxide and methotrexate increases the side effects of this cytotoxic drug.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

During pregnancy, it is recommended not to exceed a concentration of 50% medical nitrous oxide in the inhaled mixture.

Driving and operating machinery:

It is recommended not to drive vehicles and not to operate machinery in the 24 hours following anesthesia in which medical nitrous oxide has been used.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of nitrogen oxide and administer it through an appropriate system that will ensure the supply of the correct amount of oxygen.

If you estimate that the action of Medical Nitrogen Oxide Nippon Gases is too strong or too weak, inform your doctor.

If you use moreMedical Nitrogen Oxide Nippon Gasesthan you should:

In the case of overdose, there is a risk of cyanosis and hypoxia. Nitrogen oxide administration should be interrupted, and the patient should be ventilated (air or oxygen).

If you are concerned that you have received too much Medical Nitrogen Oxide, speak with your doctor or another healthcare professional immediately.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Inform your doctor as soon as possible if you experience any of the following symptoms:

-Nausea and vomiting

-Increased airway pressure and/or volume in the body

-Severe hematological disorders:megablastic anemia, leukopenia, agranulocytosis, inperiods of administration exceeding 24 hours.

-Euphoric effects

-Effects on the central nervous system:myeloneuropathies, neuropathies, and other neurological adverse reactions due to vitamin B12 deficiency, generalized seizures of unknown frequency.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

All guidelines related to the installation and handling of pressure vessels must be followed.

The following general considerations should be taken into account:

• Install and store the container in a well-ventilated area.
• Store it away from flammable materials.
• Keep it separate from storage containers of flammable gases or other combustible materials.
• Keep it away from ignition sources, including static discharge.
• Keep the storage area clean.
• Keep the containers below50°C.
• Always keep the container in an upright position.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofNippon Gases Medical Nitrogen Oxide

The active principle is medical nitrous oxide and its concentration is greater than 98% by volume.

It does not contain excipients.

Appearance of the product and contents of the packaging

The fixed cryogenic containers are stainless steel cryogenic tanks of various capacities. The different sizes are classified by their approximate geometric capacity in liters and the content in kg of product and m3of gas that they provide at a pressure of 1 bar at 15°C:

Cryogenic container of 2200 liters provides 1454 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 3000 liters provides 1983 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 3300 liters provides 2181 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 6100 liters provides 4032 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 11000 liters provides 7271 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 13400 liters provides 8857 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 17000 liters provides 11237 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 20000 liters provides 13220 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 28000 liters provides 18508 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 32000 liters provides 21152 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 37000 liters provides 24457 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 41000 liters provides 27101 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 50000 liters provides 33050 m3of gas at a pressure of 1 bar at 15°C

Cryogenic container of 60000 liters provides 39660 m3of gas at a pressure of 1 bar at 15°C

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

NIPPON GASES ESPAÑA S.L.U.

C/Orense, 11

28020 Madrid.

Spain

Responsible for manufacturing:

IJSFABRIEK STROMBEEK N.V.

Broeckstraat 70 B

1860 Meise (Belgium)

Ó

SE DE CARBUROS METÁLICOS S.A.

C/ Aragón 300

08009 Barcelona

SPAIN

Date of the last review of this prospectus:05/2019

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

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This information is intended solely for healthcare professionals.

Follow the specific operating and usage instructions that come with the equipment installation.

In case of anomalies, contact the technical service of the distribution center indicating the anomaly detected.

• Do not smoke when handling the product, nor light a fire.
• Do not use grease or oil.
• Do not allow substances to flow back into the container.
• Prevent water from entering the container.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Open the valves slowly and close them when the product is not in use.
• In liquid or cold gas form, handle with suitable materials to avoid cryogenic burns if it comes into contact with the skin.

For the specific case of medical nitrous oxide at low temperature, some additional particularities of the product must be taken into account as precautions for its use and handling:

• Medical nitrous oxide is a gas heavier than air, which can accumulate in low points after vaporization of the liquid and make the atmosphere hazardous.
• Medical nitrous oxide at low pressure, stored in cryogenic containers, is at low temperature (around -20°C to 18 bar) and can cause cryogenic burns if it comes into contact with the skin in the event of splashes or handling of the liquid without the appropriate protective equipment.
• The expansion of medical nitrous oxide liquid by heating is more than 600 times its liquid volume, and therefore precautions should be taken for overpressures in closed volumes (equipment and installations) and the atmosphere of the rooms.

The medical nitrous oxide containers are reserved exclusively for therapeutic use.

Medical nitrous oxide must be used exclusively in a mixture with medical oxygen.

To avoid any incident, it is necessary to respect the following instructions:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy,
• Never clean with combustible products, especially if they are greasy, nor the equipment that contains this gas nor the taps, joints, seals, closing devices, and valves,
• Never apply greasy substances (vaseline, creams, etc.) to the patients' faces,
• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or nearby.
• Verify the good condition of the material before its use.
• Handle the material with clean and grease-free hands.
• For the manipulation of cryogenic containers, use the indicated protective equipment (glasses or visors, clean gloves for that use, adaptation of clothing, etc.) and follow the instructions and precautions described for the operation.
• Use specific connections or flexible connection elements for nitrous oxide.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Prevent safety devices against overpressures in each zone of the circuit where there may be residues of medical nitrous oxide liquid between two valves.
• Never touch the cold or frozen parts of the material.

• Never force any part of the cryogenic container or attempt to repair defective valves, in case of problems contact the supplier.
• In case of a leak, close the tap or the feeding valve of the circuit that has a defect in tightness and check that the emergency device is activated.

In case of cryogenic burn, abundantly rinse with water.