Prospect: Information for the User

Metallic Carburets Nitrous Oxide, 98.0% V/V, medicinal liquefied gas, in a fixed cryogenic container

Nitrous Oxide

Contents of the container and additional information

Medical Nitrous Oxide Carbureted Methyl Alcoholis a medicinal liquefied gas.

What is it Used For?

The treatment with nitrous oxide is indicated in thefollowing cases:

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

Do not use Nitric Oxide Medicinal Carbures Metálicos

• If you need pure oxygen ventilation.
• If you have undrained pneumothorax, particularly intracranial or bullous emphysema.
• Do not use for more than 24 hours consecutively.

Warnings and Precautions

• If you have heart failure, monitor that you do not have a drop in blood pressure.
• If you are to be surgically intervened in the ear and adjacent air areas.

Use of Nitric Oxide Medicinal with other medications

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

Nitric oxide potentiates the hypnotic effects of intravenous or inhalation anesthetics (thiopental, benzodiazepines, morphines, halogenated), so you should decrease the dosage of these.

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

Pregnancy and lactation and fertility

Pregnancy

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

Obstetric anesthesia:

Due to the rapid transfer of the feto-placental barrier, it is recommended to interrupt the administration of nitric oxide if the time interval between the induction of anesthesia and fetal extraction exceeds 20 minutes.

Avoid the use of nitric oxide in case of fetal distress.

Obstetric analgesia:

The use of nitric oxide in this indication can only be made if a safety meter is available that prevents the administration of nitric oxide at a concentration higher than 50%.

Lactation

Consult with your doctor before using the medication.

Driving and operating machines

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

Medical nitrous oxide is intended for exclusive hospital use.

Thenitrous oxidemust only be administered in the operating room or delivery room.

The doctor will determine the necessary dose ofnitrous oxideand it will be administered through an appropriate system to meet their needs, ensuring the supply of the correct amount of oxygen.

If You Use More Medical Nitrous Oxide Metal Carbonyls Than You Should:

In case of overdose, there is a risk of cyanosis and hypoxia. Administration ofnitrous oxideMedical must be interrupted and the patient ventilated (air and oxygen).

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 available data

Very common

• Nausea and vomiting.
• Hypoxia, during several minutes after the completion of nitrous oxide administration.

Common

• Middle ear disorders
• Temporary increase in pressure and/or volume of the air-filled cavities of the body, normal or pathological.
• Glaucoma

Uncommon

• Illusions (May produce psychodisruptive effects in the absence of combination with another anesthetic)

Rare

• Paraparesis

Very rare

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

Unknown

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Medicinal Nitrous Oxide Metal Cylinders after the expiration date.

Fixed cryogenic containers:

• Must be installed outdoors in a clean area, free from flammable materials, reserved for the storage of medicinal gases.

• Smoking, lubricating equipment, and making fire in the area where the fixed cryogenic containers are located is prohibited.

• 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 shock risks, 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.

Composition of Medical Nitrous Oxide Metal Carbures

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

No other excipients are contained.

Appearance of the product and contents of the container

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

Holder of the marketing authorization and responsible for manufacturing

S.E. of METAL CARBURES, S.A.

Avda. de la Fama, 1

08940 Cornellà de Llobregat,

Spain

Responsible for manufacturing

S.E. of METAL CARBURES, S.A.

Ctra. Pobla a Tarragona, km 2

43140 – La Pobla de Mafumet, Tarragona

Spain

This prospectus has been approved in: October 2023

The detailed information of this medication 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:

Nitrous oxide is reserved for exclusive medical use.

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

To avoid accidents, the following instructions will be respected:

• Liquid projection would cause severe cryogenic burns (very cold). In case of burn, abundantly rinse with water.
• Ventilate if possible the place of use.
• Check the good condition of the materials before use.
• Perform any manipulation on nitrous oxide containers wearing clean gloves adapted to that use and without grease and protective glasses.
• Never touch the cold or frosty parts of the material.
• Manipulate the material with clean and grease-free hands.
• Use a specific nitrous oxide valve.
• Use flexible connections to wall outlets provided with specific nitrous oxide medical connections.
• Do not use intermediate valves that allow connecting two devices that do not fit.
• Verify beforehand the compatibility of the materials in contact with medical nitrous oxide, in particular use connection joints to the manometer provided for this gas. Check the state of the joints.
• Do not smoke, do not approach a flame, and do not grease.

IMPORTANT:

• Never introduce this gas into an apparatus that may be suspected of containing combustible bodies and in particular fatty bodies.
• Never clean with combustible products and in particular fatty bodies, the containers containing this gas, valves, joints, closure devices, as well as circuits.
• Do not apply greasy substances (vaseline, ointments, etc.) to the patients' faces.
• Do not use aerosol generators (lacquer, deodorants, etc.), of solvents (alcohol, gasoline, etc.) on the material or in its vicinity.
• When the ambient temperature is low, the flow may decrease, even interrupt due to insufficient pressure.
• Avoid using medical nitrous oxide at a temperature below0 °Cto avoid a pressure drop in case of intensive use.
• Never use medical nitrous oxide for leak tests, for feeding pneumatic tools, and for blowing tubes.
• The mean exposure limit value (during 8 hours) to nitrous oxide is set at 25 ppm for the exposure of personnel.

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