NITROUS OXIDE MEDICAL METAL CARBIDES 98.0% V/V LIQUEFIED MEDICINAL GAS IN FIXED CRYOGENIC CONTAINER

Introduction

Package Leaflet: Information for the User

Nitrous Oxide Medicinal Carburos Metálicos, 98.0% V/V, Liquid Medical Gas, in Fixed Cryogenic Container

Nitrous oxide

Contents of the Package Leaflet:

1. What is Nitrous Oxide Medicinal and what is it used for
2. Before starting treatment with Nitrous Oxide Medicinal
3. How to use Nitrous Oxide Medicinal
4. Possible side effects
5. Storage of Nitrous Oxide Medicinal

Contents of the packaging and additional information

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

Nitrous Oxide Medicinal Carburos Metálicos is a liquid medical gas.

What is it used for?

Treatment with nitrous oxide is indicated in the following cases:

• Adjuvant to general anesthesia, in combination with all anesthetic agents administered intravenously or by inhalation.
• Adjuvant to analgesia in the operating room or delivery room.

2. What you need to know before starting treatment with Nitrous Oxide Medicinal Carburos Metálicos

Do not useNitrous Oxide Medicinal Carburos Metálicos

• If you need ventilation with pure oxygen.
• If you have undrained air embolisms, particularly intracranial or pneumothorax, bullous emphysema.
• Do not use for more than 24 hours in a row.

Warnings and Precautions

• If you have heart failure, monitor your blood pressure to avoid hypotension.
• If you are going to undergo ear surgery or surgery in adjacent air-filled areas.

Use ofNitrous Oxide Medicinalwith other medicines

Tell your doctor if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Nitrous oxide enhances the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphinics, halogenated), so the dosage of these should be reduced.

You should also inform your doctor if you are taking medicines that contain methotrexate (e.g., for rheumatoid arthritis).

Pregnancy and Breastfeeding and Fertility

Pregnancy

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

Obstetric Anesthesia:

Due to the rapid passage through the fetoplacental barrier, it is recommended to interrupt the administration of nitrous oxide if the time between the induction of anesthesia and the extraction of the fetus exceeds 20 minutes.

Avoid using nitrous oxide in case of fetal distress.

Obstetric Analgesia:

The use of nitrous oxide for this indication can only be performed if a safety flowmeter is available that prevents the administration of nitrous oxide at a concentration greater than 50%.

Breastfeeding

Consult your doctor before using the medicine.

Driving and Using Machines

It is recommended not to drive vehicles and not to use machines during the 24 hours following anesthesia with nitrous oxide.

3. How to use Nitrous Oxide Medicinal Carburos Metálicos

Nitrous oxide medicinal is intended for exclusive hospital use.

Nitrous oxide should only be administered in the operating room or delivery room.

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

If you use more Nitrous Oxide Medicinal Carburos Metálicos than you should:

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

4. Possible Side Effects

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

The assessment of side effects is based on the following frequencies:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Unknown: cannot be estimated from the available data

Very Common

• Nausea and vomiting.
• Hypoxia, for several minutes after the end of nitrous oxide administration.

Common

• Middle ear disorders.
• Temporary increase in pressure and/or volume of the body's air cavities, normal or pathological.
• Ocular hypertension.

Uncommon

• Hallucinations (Psychodysleptic effects may occur in the absence of combination with another anesthetic).

Rare

• Paraparesis.

Very Rare

• Severe hematological disorders (megaloblastic anemia, agranulocytopenia) have been described for treatments lasting more than 24 hours.
• Arrhythmia, Heart Failure.
• Epilepsy, increased intracranial pressure.
• Psychotic disorder, confusion, anxiety, euphoric mood.
• Pneumothorax.
• Hypotension.

Unknown

• Myelopathy, subacute combined degeneration of the spinal cord, polyneuropathy, generalized seizures.
• Addiction.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Carburos Metálicos

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

Do not use Nitrous Oxide Medicinal Carburos Metálicos after the expiration date.

Fixed cryogenic containers:

• Must be installed outdoors in a clean area, without flammable materials, reserved for the storage of medicinal gases.
• It is forbidden to smoke, grease equipment, and make fire in the area where the fixed cryogenic containers are located.
• Do not park in the area of the fixed cryogenic containers.
• Monitor the risk of asphyxiation.
• Fixed cryogenic containers must be protected from shock hazards, particularly filling, emptying, and safety elements (valves, manometers), heat sources or ignition, temperatures above 50°C, and combustible materials.
• The pressure inside the distribution pipelines from the fixed cryogenic container must not exceed 10 bar.

6. Contents of the Packaging and Additional Information

Composition of Nitrous Oxide Medicinal Carburos Metálicos

The active ingredient is nitrous oxide. The concentration is greater than 98.0% V/V.

It does not contain other excipients.

Appearance of the Product and Contents of the Packaging

Fixed cryogenic containers have different average capacities: 3000, 6000, and 10000 liters.

Marketing Authorization Holder and Manufacturer

S.E. de CARBUROS METÁLICOS, S.A.

Avda. de la Fama, 1

08940 Cornellà de Llobregat,

Spain

Manufacturer

S.E. de CARBUROS METÁLICOS, S.A.

Ctra. Pobla a Tarragona, km 2

43140 – La Pobla de Mafumet, Tarragona

Spain

This package leaflet was approved in: October 2023

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

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This information is intended only for healthcare professionals:

Nitrous oxide is reserved for exclusive medical use.

Nitrous oxide medicinal must be used exclusively in a mixture with medical oxygen, the oxygen concentration (FiO2) should never be less than 21%.

To avoid accidents, the following guidelines must be respected:

• The projection of liquid could cause severe cryogenic burns (very cold). In case of burns, rinse abundantly with water.
• Ventilate if possible the place of use.
• Check the good condition of the materials before use.
• Perform any manipulation of nitrous oxide containers wearing clean gloves adapted to this use and without grease, and protective glasses.
• Never touch the cold or frosted parts of the material.
• Handle the material with clean and grease-free hands.
• Use a specific connector for nitrous oxide.
• Use connection hoses to wall outlets provided with specific connections for nitrous oxide medicinal.
• Do not use an intermediate connector that allows connecting two devices that do not fit.
• Check beforehand the compatibility of materials in contact with nitrous oxide medicinal, in particular use connection gaskets to the manoreducer provided for this gas. Check the condition of the gaskets.
• Do not smoke, do not approach a flame, and do not grease.

IMPORTANT:

• Never introduce this gas into a device that may be suspected of containing combustible bodies, particularly fatty bodies.
• Never clean with combustible products, particularly fatty bodies, the containers that contain this gas, valves, gaskets, closing devices, as well as circuits.
• Do not apply greasy substances (vaseline, ointments, etc.) to the face of patients.
• Do not use aerosol generators (lacquers, deodorants, etc.), solvents (alcohol, gasoline, etc.) on the material or in its proximity.
• When the ambient temperature is low, the flow may decrease, even interrupt, due to insufficient pressure.
• Avoid using nitrous oxide medicinal at a temperature below 0°C to avoid a drop in pressure in case of intensive use.
• Never use nitrous oxide medicinal for tightness tests, for powering pneumatic tools, and for blowing pipes.
• The average exposure limit value (for 8 hours) to nitrous oxide is set at 25 ppm for exposure of personnel.

Perform systematic ventilation of the place of use, evacuating the exhaled gases to the outside and avoiding places where they could accumulate. It is convenient, before any use, to ensure the possibility of evacuating gases in case of an accident or unexpected leak.