Nitrous oxide medicinal Nippon Gases, 98.0%, medicinal liquefied gas in fixed cryogenic container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Nitrous Oxide

Read the entire leaflet carefully before you start using this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Protóxido de Nitrógeno Medicinal Nippon Gases is and what it is used for

Protóxido de Nitrógeno Medicinal Nippon Gases belongs to a group of medicines called general anesthetics.

This medicine is indicated as:

• An adjunct to general anesthesia, in combination with all anesthetic agents administered intravenously or by inhalation.

An adjunct to analgesia in the operating room or in the delivery room.

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

Do not use Medicinal Nitrous Oxide Nippon Gases

If you require ventilation with pure oxygen

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

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

Must not be administered for longer than 24 hours

Warnings and precautions:

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

Caution is recommended in patients with cardiac failure and in patients who have undergone sinus or inner ear surgery.

Other medicines and Medicinal Nitrous Oxide Nippon Gases:

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

Medicinal nitrous oxide potentiates the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphine derivatives, halogenated agents).

The combined use of medicinal nitrous oxide and methotrexate increases the adverse effects of this cytotoxic drug.

Pregnancy, breastfeeding, and fertility:

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

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

Driving and using machines:

It is recommended not to drive vehicles or operate machinery within 24 hours following anesthesia in which medicinal nitrous oxide has been used.

3. How to use Nitrous Oxide Medicinal Nippon Gases

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The doctor will determine the correct dose of nitrous oxide and will administer it to you using a system appropriate to your needs, which will ensure the delivery of the correct amount of oxygen.

If you feel that the effect of Nitrous Oxide Medicinal Nippon Gases is too strong or too weak, inform your doctor.

If you use more Nitrous Oxide Medicinal Nippon Gases than you should:

In the event of an overdose, there is a risk of cyanosis and hypoxia. Administration of medicinal nitrous oxide must be stopped, and the patient should be ventilated (with air or oxygen).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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, leucopenia, agranulocytosis, during administration periods longer than 24 hours.

-Euphoric effects

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

Reporting of 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 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 Nitrous Oxide 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 precautions should be observed:

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the packaging and other information

Composition of Medicinal Nitrous Oxide Nippon Gases

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

It contains no excipients.

Appearance of the product and contents of the packaging

Fixed cryogenic containers are stainless steel cryogenic tanks of various capacities. The different sizes are indicated according to their approximate geometric capacity in liters, and the content in kg of product and m³ of gas provided at a pressure of 1 bar and 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 SANSO 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 the most recent review of this leaflet: 05/2019

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

This information is intended exclusively for healthcare professionals.

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

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

• Do not smoke or light flames when handling the product.
• Do not use greases or oils.
• Do not allow substances to backflow into the container.
• Prevent water from entering the container.
• Use only equipment specifically approved for this product and for the intended pressure and temperature conditions.
• Open valves slowly and close them when the product is not in use.
• When handling in liquid form or as cold gas, use appropriate materials to prevent cryogenic burns in case of contact with the skin.

For the specific case of nitrous oxide at low temperature, additional product-specific characteristics must also be considered as precautions for its use and handling:

• Nitrous oxide is a gas heavier than air, which may accumulate in low-lying areas after vaporization of the liquid, creating a hazardous atmosphere.
• Nitrous oxide at low pressure, as stored in cryogenic tanks, is at low temperature (approximately -20°C at 18 bar), and may cause frostbite if it comes into contact with the skin during splashing or handling of the liquid without appropriate protective equipment.
• The expansion of liquid nitrous oxide upon warming is more than 600 times its liquid volume; therefore, precautions against overpressure must be taken in closed volumes (equipment and installations) and in enclosed spaces.

Containers of medicinal nitrous oxide are reserved exclusively for therapeutic use.

Medicinal nitrous oxide must be used exclusively in mixture with medicinal oxygen.

To prevent any incidents, the following instructions must be strictly observed:

• Never introduce this gas into a device suspected of containing combustible materials, especially those of a greasy nature.

• Never clean devices containing this gas, or taps, seals, gaskets, closure devices, or valves with flammable products, especially those of a greasy nature.

• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.

• Do not use aerosols (hair spray, deodorants, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

• Check the equipment is in good condition before use.

• Handle the equipment with clean, grease-free hands.

• For handling cryogenic containers, use the specified personal protective equipment (goggles or face shields, clean gloves designated for this purpose, appropriate clothing, etc.) and follow the instructions and precautions described for the operation.

• Use connections or flexible connection elements specifically designed for nitrous oxide.

• Use only equipment specifically approved for this product and for the intended pressure and temperature conditions.

• Provide safety devices against overpressure in each section of the circuit where residual liquid nitrous oxide may remain trapped between two valves.

• Never touch cold or frozen parts of the equipment.

• Never force any part of the cryogenic container or attempt to repair faulty valves; in case of problems, contact the supplier.

• In case of leakage, close the tap or supply valve of the circuit with the leakage and verify that the emergency device is activated.

In case of cryogenic burn, rinse thoroughly with water.