Leaflet: information for the user

Medical Nitrogen Oxide Nippon Gases, 98%,medical liquefied gas in gas cartridge

Nitrous Oxide

Read this 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 or nurse.
• This medicine has been prescribed for you only, 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 side effects, consult your doctor, 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 side 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 intravenously or by inhalation.

Adjunct to analgesia in operative or delivery room settings.

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 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, lactation, and fertility:

If you are pregnant or breastfeeding, or believe 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 machines:

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

Follow exactly the administration instructions of this medication 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 a suitable system that will ensure the supply of the correct amount of oxygen.

If you estimate that the action ofMedical Nitrogen Oxide Nippon Gasesis too strong or 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 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 air pressure and/or volume in the body's air cavities

-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 Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about 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 containers must be followed.

• Store the container in a well-ventilated area.
• Store away from combustible materials.
• Separate containers during storage of flammable gases or other combustible materials.
• Keep away from ignition sources, including static discharge.
• Keep containers below50ºC.
• Always keep the container in an upright position.

In addition to the above precautions, the following must be taken into account:

Storage of gas cylinders

The rooms must be protected from the elements, clean, and reserved for medical use storage.

Storage of gas cylinders in the user service and at home:

The gas cylinder must be installed in a location that allows it to be protected from the risks of impacts and falls (such as a support with fixing elements), from heat sources or ignition, from temperatures equal to or above50ºC, from combustible materials, and from the elements.

Excessive storage should be avoided.

Transportation of gas cylinders:

Gas cylinders must be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of impacts or falls. Special attention must be given to securing the regulator to avoid accidental ruptures.

During transportation in vehicles, gas cylinders must be solidly grouped. Permanent ventilation of the vehicle is obligatory, and smoking is strictly prohibited.

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

Medicines should not be throwndown the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition ofNippon Gases Medical Nitrogen Oxide

The active ingredient 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 package

Gas balls:

The gas balls are made of welded steel of various sizes. The gas balls are identified by the colors defined by the specific legislation for the product, which, as of this review, are the white body and blue tip.

Sizes:

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:

Gas balls of 1L that contain0.75 kgand provide0.40 m3of gas

Gas balls of 2L that contain1.50 kgand provide0.80 m3of gas

Gas balls of 3L that contain2.25 kgand provide1.20 m3of gas

Gas balls of 3.4L that contain2.55 kgand provide1.35 m3of gas

Gas balls of 5L that contain3.75 kgand provide2.00 m3of gas

Gas balls of 7L that contain5.25 kgand provide2.80 m3of gas

Gas balls of 10L that contain7.50 kgand provide4.00 m3of gas

Gas balls of 13L that contain9.75 kgand provide5.20 m3of gas

Gas balls of 20L that contain15.0 kgand provide8.00 m3of gas

Gas balls of 30L that contain22.50 kgand provide11.90 m3of gas

Gas balls of 40L that contain30.0 kgand provide16.00 m3of gas

Gas balls of 50L that contain37.50 kgand provide 20.00 m3of gas

Authorized holder of marketing authorization and responsible for manufacturing

Authorized holder of marketing authorization:

NIPPON GASES ESPAÑA S.L.U.

C/Orense, 11

28020 Madrid.

Spain

Responsible for manufacturing:

NIPPON GASES ESPAÑA S.L.U.

Calle Embajadores 474, Villaverde

28053 Madrid

Spain

Last review date of this prospectus:05/2019

The detailed information of this medicine 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.

• Do not smoke when handling the product or light a fire.
• Do not use grease or oil.
• Do not drag or roll in a horizontal position. If the package is not small, use suitable dollies or roll in a nearly vertical position on its base.
• 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 not in use.
• It is prohibited for the user to pass the gas from one gas ball to another.
• In liquid or cold gas form, handle with suitable materials to avoid freezing burns if it comes into contact with the skin.

The medical nitrogen oxide gas balls are reserved exclusively for therapeutic use.

• Before using, verify the good condition of the material (container, delivery seal, valve, connections, administration accessories, etc.) and check if the content has not expired. If anomalies are detected, contact the distribution center for replacement with another container indicating the anomaly detected.
• Keep the gas ball in a vertical position (since it is a liquefied gas, a safety device for overpressure is installed on the valve, which must be in the gas phase of the gas ball) and securely fasten it to prevent accidental falling.
• If the gas ball is to be connected to a regulation and control installation of a canalized network, remove the seal, connect the connection rod without forcing the connection, and follow the handling and safety instructions of the regulation and control installation.
• Nitrous oxide is a liquefied gas that, as such, maintains a pressure equilibrium between gas and liquid phases, so its content is known by the weight of the product. When the liquid phase ends and only gas remains, the consumption of the latter translates into a rapid decrease in pressure, which will depend on the volume of the container. Therefore, when the pressure begins to decrease, it is usually an indication that there is almost no content left in the container and another container should be replaced in a very short time.
• If the gas ball is connected to a pressure regulator, remove the seal, check that the regulator is suitable for use with medical nitrous oxide, connect the regulator to the valve without forcing the connections. (Note: the pressure regulator must admit a pressure of at least 1.5 times the maximum service pressure and the low-pressure regulated part must be in the prescribed range of use). Check that the use valves and the low-pressure pressure regulator wheel are closed.
• If you want to open it, stand to one side of the regulator. Verify that the gas ball has pressure by opening the valve slowly and gradually checking the reading on the high-pressure side of the regulator, checking for the absence of leaks.
• After the regulator, the administration accessories defined for the gas are connected (mixer with oxygen, etc.) and in accordance with the prescribed conditions.
• Gradually open the pressure wheel on the low-pressure side until the desired pressure is obtained and then gradually open the flow valves on the consumption side (flowmeters, shut-off valves, etc.).
• Do not keep the valve of the gas ball open if not in use.

Once the content is finished (not less than 10 bar), close the consumption valve, close the gas ball valve, disconnect the pressure regulator, remove the chain or securing element and remove to the empty container area, contacting the distribution center for replacement with a full container or the return of the same.