Nitrous oxide medicinal Carbuuros Metalicos 98.0% v/v liquefied medicinal gas in fixed cryogenic container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Medicinal Nitrous Oxide Carburos Metálicos, 98.0% V/V, liquefied medicinal gas in fixed cryogenic container

Nitrous oxide

Package leaflet contents:

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

Pack contents and additional information

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

Nitrous Oxide Medicinal Carburos Metálicos is a liquefied medicinal gas.

What is it used for?

Nitrous oxide treatment is indicated in the following cases:

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

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

Do not use Medicinal Nitrous Oxide Carburos Metálicos

• If you require ventilation with pure oxygen.
• If you have undrained air leaks, particularly intracranial or pneumothorax, or giant bullous emphysema.
• Do not use for longer than 24 consecutive hours.

Warnings and Precautions

• If you have heart failure, monitor for possible drop in blood pressure.
• If you are undergoing surgical procedures on the ear or adjacent air-containing cavities.

Use of Medicinal Nitrous Oxide with other medicines

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

Nitrous oxide potentiates the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphine derivatives, halogenated agents); therefore, the dosage of these agents should be reduced.

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

Pregnancy, lactation, and fertility

Pregnancy

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

Obstetric anesthesia:

Due to rapid passage across the fetoplacental barrier, administration of nitrous oxide should be discontinued if the time between induction of anesthesia and delivery of the fetus exceeds 20 minutes.

Avoid use of nitrous oxide in cases of fetal distress.

Obstetric analgesia:

The use of nitrous oxide for this indication should only be performed if a safety flowmeter is available that prevents administration of nitrous oxide at concentrations exceeding 50%.

Lactation

Consult your doctor before using this medicine.

Driving and use of machines

It is recommended not to drive vehicles or operate machinery during the 24 hours following anesthesia with nitrous oxide.

3. How to use Medicinal Nitrous Oxide Carburos Metálicos

Medicinal nitrous oxide is intended for hospital use only.

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

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

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

In case of overdose, there is a risk of cyanosis and hypoxia. Administration of Medicinal Nitrous Oxide must be stopped and the patient must be ventilated (with air and oxygen).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The assessment of adverse 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
Not known: cannot be estimated from the available data

Very common

• Nausea and vomiting
• Hypoxia, for several minutes after completion of nitrous oxide administration

Common

• Middle ear disorders
• Temporary increase in pressure and/or volume of normal or pathological air-filled body cavities
• Ocular hypertension

Uncommon

• Hallucinations (psychodysleptic effects may occur in the absence of combination with another anaesthetic)

Rare

• Paraparesis

Very rare

• Severe haematological disorders (megaloblastic anaemia, agranulocytopenia) have been reported with treatments lasting longer than 24 hours
• Arrhythmia, heart failure
• Epilepsy, increased intracranial pressure
• Psychotic disorder, confusion, anxiety, euphoric mood
• Pneumothorax
• Hypotension

Not known

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Metal Carbides

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

Do not use Medicinal Nitrous Oxide Metal Carbides after the expiry date.

Fixed cryogenic containers:

• Must be installed outdoors in a clean area, free from flammable materials, designated exclusively for the storage of medicinal gases.
• Smoking, greasing equipment, and open flames are prohibited in the area where the fixed cryogenic containers are located.
• Parking is not allowed in the area of the fixed cryogenic containers.
• The risk of asphyxiation must be monitored.
• Fixed cryogenic containers must be protected from impact hazards, particularly the filling, emptying, and safety components (valves, pressure gauges), as well as from sources of heat or ignition, temperatures above 50°C, and combustible materials.
• The pressure within the distribution piping from the fixed cryogenic container must not exceed 10 bar.

6. Contents of the container and other information

Composition of Medicinal Nitrous Oxide by Carburos Metálicos

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

It contains no other excipients.

Appearance of the product and contents of the container

Fixed cryogenic containers have various average capacities: 3000, 6000, and 10,000 litres.

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

IJSFABRIEK STROMBEEK N.V.
Broekstraat 70
1860 Meise
Belgium

This leaflet was approved in: November 2025

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

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This information is intended exclusively for healthcare professionals:

Nitrous oxide is reserved for exclusive medical use.

Medicinal nitrous oxide must be used exclusively in a mixture with medicinal oxygen; the oxygen concentration (FiO2) must never be less than 21%.

To prevent accidents, the following safety instructions must be observed:

• Projection of liquid may cause severe cryogenic burns (extremely cold). In case of burns, rinse thoroughly with abundant water.
• Ventilate the area of use if possible.
• Check the condition of equipment before use.
• Perform any handling operations on nitrous oxide containers wearing clean gloves suitable for this purpose and free of grease, as well as protective goggles.
• Never touch cold or frosted parts of the equipment.
• Handle equipment with clean hands free of grease.
• Use a specific connector for nitrous oxide.
• Use flexible hoses for connection to wall outlets equipped with specific connectors for medicinal nitrous oxide.
• Do not use an intermediate connector that allows the connection of two incompatible devices.
• Verify beforehand the compatibility of materials in contact with medicinal nitrous oxide, particularly using gaskets for pressure regulators designed for this gas. Check the condition of the gaskets.
• Do not smoke, do not approach open flames, and do not apply grease.

IMPORTANT:

• Never introduce this gas into any apparatus that might contain flammable materials, particularly greasy substances.
• Never clean containers containing this gas, valves, gaskets, closure devices, or circuits with flammable products, particularly greasy substances.
• Do not apply greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosol generators (hair spray, deodorants, etc.) or solvents (alcohol, gasoline, etc.) on the equipment or in its vicinity.
• When ambient temperature is low, the flow rate may decrease or even stop due to insufficient pressure.
• Avoid using medicinal nitrous oxide at temperatures below 0°C to prevent pressure drops during intensive use.
• Never use medicinal nitrous oxide for leak testing, powering pneumatic tools, or blowing through pipes.
• The time-weighted average exposure limit (over 8 hours) to nitrous oxide is set at 25 ppm for personnel exposure.

Ensure systematic ventilation of the area of use, evacuating exhaled gases to the outside and avoiding areas where gases could accumulate. It is advisable, prior to any use, to ensure the possibility of evacuating gases in case of accident or unexpected leakage.