Label: Information for the User

Metallic Carbonyl Nitrous Oxide, 98.0% v/v medicinal liquefied gas in gas cartridge

Nitrous Oxide

Medical Nitrous OxideMetal Carbonylsis a medicinal liquefied gas.

What is it used for?

The treatment with nitrous oxide is indicated in thefollowing cases:

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

Do not use Medical Nitrous Oxide Metals Carbures

• If you need pure oxygen ventilation.
• If you have undrained pneumothorax, particularly intracranial or globular 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 Medical Nitrous Oxide with other medications

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

Medical nitrous 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% of nitrous oxide in the inhaled mixture.

Obstetric anesthesia:

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

Avoid the use of nitrous oxide in case of fetal suffering.

Obstetric analgesia:

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

Lactation

Consult with your doctor before using the medication.

Driving and use of machines

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

Nitrous oxide medical cartridgesare intended for exclusive hospital use.

Nitrous oxideshould 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 that will ensure the supply of the correct amount of oxygen.

If you use more Medical Nitrous Oxide Metallic Carbures than you should:

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

Like all medicines, this medicine can 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 convulsions
• 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.

Maintain this medication out of sight and reach of children

Storage of gas cylinders within the storage area:

• Gas cylinders must always be kept in an upright position, with valves closed.
• Do not use Nitrous OxideMedicinal Metal Cylinders after the expiration date indicated on the label of the container, after CAD.
• Gas cylinders must be stored in a well-ventilated or ventilated area, protected from the elements, away from frost, clean, free from flammable materials, reserved for the storage of medical gases and locked with a key.
• Empty and full gas cylinders must be stored separately.
• Gas cylinders must be protected from the risks of shocks and falls, from heat sources or ignition, from flammable materials, from the elements, and from temperatures above 50 °C.
• Upon delivery by the manufacturer, gas cylinders must be provided with an intact seal of inviolability system.
• Empty gas cylinders must be stored in an upright position with the valve closed, to prevent any corrosion in the presence of humidity.

Storage of gas cylinders during use:

• Gas cylinders must be installed in a conditioned area with suitable material (with fixation belts) to keep them in an upright position.
• Gas cylinders must be protected against the risks of shocks or falls, from heat sources or ignition, and from temperatures above 50 °C.
• Before use, gas cylinders must be kept with the valve closed, and excessive storage of containers must be avoided.

Transportation of gas cylinders:

• Gas cylinders must be transported in an upright position and with suitable material (type of car provided with chains, barriers, or rings) to protect them from the risks of shocks and falls and to prevent the risk of burns in case of valve opening.
• Particular attention must also be paid to the fixation of the regulator to avoid accidental rupture.

Composition ofNitrous OxideMedical Metallic Carbures

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

No other excipients are contained.

Aspect of the product and content of the package

Nitrous OxideMedical Metallic Carburesis presented in the form of compressed gas capsules. The gas capsules can be made of steel or aluminum of the following volumes:0.5 L, 1 L, 2 L, 3 L, 4 L, 5 L, 7 L, 10 L, 13 L, 15 L, 20 L, 25 L, 30 L, 40 L, 50 L in liters. Not all package sizes are marketed.

Holder of the marketing authorization

S.E. de CARBUROS METÁLICOS, S.A.

Avenida de la Fama, 1

08940 Cornellà de Llobregat, Barcelona

Spain

Responsible for manufacturing

S.E. de CARBUROS METÁLICOS S.A.

Ctra. De Toledo, 7

28300 Aranjuez

SPAIN

AIR PRODUCTS TEMPLEMARS

Industrial Zone of l'Epinoy

59175 Templemars

FRANCE

This prospectus has been approved in: October 2023

The detailed information of this medicine 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.

Nitrous oxide medicinal 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 followed:

• Always keep the gas capsule in a vertical position, to avoid the risk of liquid projection, which would cause severe cryogenic burns (very cold). In case of burn, abundantly rinse with water.
• Consider that the gas pressure in the capsule remains constant (50 bar at15 ºC), regardless of the residual liquid level, and is not a reflection of the remaining amount. When the capsule no longer contains gas, and only at that moment, the pressure drops rapidly. Only the weight of the gas capsule allows estimating its content during use.
• Ventilate the area of use if possible.
• 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 frosted parts of the material.
• Do not manipulate a gas capsule whose valve is not protected by a tulip.
• Manipulate the material with clean and grease-free hands.
• Manipulate gas capsules wearing safety shoes when required.
• Hold the gas capsules with an appropriate means (chains, hooks, etc.) to keep them in a vertical position and prevent any fall.
• Never force the placement of a gas capsule in a support where it enters with difficulty
• Do not lift the gas capsule by its valve.
• Use a specific nitrous oxide adapter.
• Use a flow regulator with a flowmeter that can admit a pressure at least equal to 1.5 times the maximum service pressure of the gas capsule.
• Use flexible connections to the wall outlets provided with specific connections for nitrous oxide medicinal.
• Do not use intermediate adapters that allow connecting two devices that do not fit.
• Open the valve gradually.
• Never force the valve to open. Do not open it either at full speed.
• Purge the outlet adapter of the gas capsule before connecting the flow regulator to eliminate any possible dust particles.
• Never position yourself in front of the valve outlet, but always on the opposite side of the flow regulator, behind the gas capsule and away from it. Do not expose the patient to the gas flow.
• Verify the compatibility of the materials in contact with nitrous oxide medicinal beforehand, particularly using connection joints to the flow regulator designed 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 particularly fatty bodies.
• Never clean with combustible products and particularly fatty bodies the containers containing this gas, the valves, joints, closure devices, and circuits.
• Do not apply greasy substances (vaseline, ointments, etc.) to the patients' faces.
• Do not use aerosol generators (lacquer, deodorants, etc.), solvents (alcohol, gasoline, etc.) on the material or in its vicinity.
• Close the valve of the gas capsule after use.
• Do not attempt to repair a defective valve.
• Do not transfer gas from one capsule to another.
• In case of leakage, close the valve that presents a leak.
• Ventilate the area where the containers are located.
• Do not use a gas capsule that presents a leak.
• In case of opening the valve with a high flow rate and formation of frost, do not use the gas capsule and contact the manufacturer.
• When the ambient temperature is low or in case of high consumption that causes the cooling of the gas capsule, the flow rate may decrease, even interrupt due to insufficient pressure in the gas capsule.
• Avoid using nitrous oxide medicinal gas capsules at a temperature below0 ºCto prevent a pressure drop in case of intensive use.
• Keep empty gas capsules with the valve closed to prevent any corrosion due to the presence of moisture.
• Do not use nitrous oxide medicinal for leak tests, for the feeding of pneumatic tools, and for blowing pipes.
• The average exposure limit (during 8 hours) to nitrous oxide is set at 25 ppm for the exposure of personnel.
• Perform systematic ventilation of the area of use, evacuating the expired gases to the outside and avoiding areas 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 leakage.