NITROGEN OXIDE MEDICAL NIPPON GASES, 98.0%, MEDICINAL LIQUEFIED GAS IN A FIXED CRYOGENIC CONTAINER

Introduction

Package Leaflet: Information for the User

Nitrous Oxide Medicinal Nippon Gases, 98%,liquid medicinal gas in fixed cryogenic container

Nitrous Oxide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Nitrous Oxide Medicinal Nippon Gases is and what it is used for
2. What you need to know before you start using Nitrous Oxide Medicinal Nippon Gases
3. How to use Nitrous Oxide Medicinal Nippon Gases
4. Possible side effects
5. Storage of Nitrous Oxide Medicinal Nippon Gases
6. Contents of the pack and other information

1. What Nitrous Oxide Medicinal Nippon Gases is and what it is used for

Nitrous Oxide Medicinal Nippon Gases belongs to a group of medicines called general anesthetics.

This medicine is indicated as:

• Adjuvant to general anesthesia, in association with all anesthetic agents administered by intravenous or inhalation route.

Adjuvant to analgesia in the operating room or delivery room.

2. What you need to know before you start using Nitrous Oxide Medicinal Nippon Gases

Do not use Nitrous Oxide Medicinal Nippon Gases

If you need ventilation with pure oxygen

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

If you have an undrained air embolism, especially intracranial or pneumothorax (air in the pleural cavity), or vesicular emphysema (bronchial obstruction).

It should not be administered for a period exceeding 24 hours

Warnings and precautions:

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

Cautious use is recommended in patients with heart failure and in patients who have undergone ear or inner ear surgery.

Other medicines and Nitrous Oxide Medicinal Nippon Gases:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Nitrous oxide enhances the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphinics, halogenated).

The combined use of 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines:

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

3. How to use Nitrous Oxide Medicinal Nippon Gases

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The doctor will determine the correct dose of nitrous oxide and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

If you think the action of Nitrous Oxide Medicinal Nippon Gases is too strong or too weak, tell your doctor.

If you use moreNitrous Oxide Medicinal Nippon Gasesthan you should:

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

If you are concerned that you have received too much Nitrous Oxide, talk to your doctor or another healthcare professional immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

-Nausea and vomiting

-Increased pressure and/or volume of the body's air cavities

-Severe hematological disorders:megaloblastic anemia, leukopenia, agranulocytosis, in administration periods exceeding 24 hours.

-Euphoric effects

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nitrous Oxide Medicinal Nippon Gases

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

All regulations regarding the installation and handling of pressure vessels must be followed.

In general, the following should be taken into account:

• Install and store the container in a well-ventilated area.
• Keep away from combustible materials.
• Separate the storage container from other containers of flammable gases or other combustible materials.
• Keep away from ignition sources, including static discharge.
• Keep the storage area clean.
• Keep the containers below 50°C.
• Always keep the container in a vertical position.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition ofNitrous Oxide Medicinal Nippon Gases

The active substance is medicinal nitrous oxide, and its concentration is greater than 98% by volume.

It does not contain excipients.

Appearance of the product and contents of the pack

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 m3 of gas they provide at a pressure of 1 bar at 15°C:

Fixed cryogenic container of 2200 liters provides 1454 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 3000 liters provides 1983 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 3300 liters provides 2181 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 6100 liters provides 4032 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 11000 liters provides 7271 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 13400 liters provides 8857 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 17000 liters provides 11237 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 20000 liters provides 13220 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 28000 liters provides 18508 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 32000 liters provides 21152 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 37000 liters provides 24457 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 41000 liters provides 27101 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 50000 liters provides 33050 m3 of gas at a pressure of 1 bar at 15°C

Fixed cryogenic container of 60000 liters provides 39660 m3 of gas at a pressure of 1 bar at 15°C

Marketing authorization holder and manufacturer

Marketing authorization holder:

NIPPON GASES ESPAÑA S.L.U.

C/Orense, 11

28020 Madrid.

Spain

Manufacturer:

IJSFABRIEK STROMBEEK N.V.

Broeckstraat 70 B

1860 Meise (Belgium)

OR

SE DE CARBUROS METÁLICOS S.A.

C/ Aragón 300

08009 Barcelona

SPAIN

Date of last revision of this leaflet:05/2019

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

-------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals.

Follow the specific operating and use instructions provided with the equipment installation.

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

• Do not smoke when handling the product, nor ignite fire.
• Do not use greases or oils.
• 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, it must be handled with materials suitable for avoiding frostbite if it comes into contact with the skin.

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

• Nitrous oxide is a gas heavier than air, which can accumulate in low points after the vaporization of the liquid and make the atmosphere dangerous.
• Nitrous oxide at low pressure, in which it is stored in cryogenic tanks, is at low temperature (around -20°C at 18 bar), and can cause frostbite if it comes into contact with the skin due to splashes or handling of the liquid without adequate protective equipment.
• The expansion of liquid nitrous oxide by heating is more than 600 times its liquid volume, and therefore, precautions against overpressure in closed volumes (equipment and installations) and the atmosphere of the rooms must be taken.

Nitrous oxide medicinal containers are exclusively reserved for therapeutic use.

Nitrous oxide medicinal must be used exclusively in a mixture with medicinal oxygen.

To avoid any incidents, the following instructions must be strictly followed:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are of a greasy nature,
• Never clean with combustible products, especially if they are of a greasy nature, either the devices that contain this gas or the taps, joints, gaskets, closing devices, and valves,
• Never apply any greasy material (vaseline, ointments, etc.) to the face of patients,
• Never use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.
• Check the good condition of the material before its use.
• Handle the material with clean and grease-free hands.
• For the handling of cryogenic containers, the indicated protective equipment (glasses or visors, clean gloves intended for this use, adaptation of clothing, etc.) must be used, and the instructions and precautions described for the operation must be followed.
• Use connections or flexible connection elements specifically approved for nitrous oxide.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Provide safety devices against overpressure in each circuit area where nitrous oxide liquid may remain between two valves.
• Never touch the cold or frozen parts of the material.

• Never force any part of the cryogenic container or try to repair faulty valves. In case of problems, contact the supplier.
• In case of leakage, close the feed valve or circuit valve that has a leak and check that the emergency device is activated.

In case of frostbite, rinse abundantly with water.