Nitrous oxide medicinal Messer, gas for inhalation in cylinder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MEDICINAL NITROUS OXIDE MESSER,

inhalation gas in cylinder

Nitrous Oxide

Read the entire leaflet carefully before you start using the medicine, because 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Contents of the leaflet:

1. What Protóxido de nitrógeno medicinal MESSER is and what it is used for
2. What you need to know before using Protóxido de nitrógeno medicinal MESSER
3. How to use Protóxido de nitrógeno medicinal MESSER
4. Possible adverse effects
5. Storage of Protóxido de nitrógeno medicinal MESSER
6. Contents of the pack and other information

1. What Protóxido de nitrógeno medicinal MESSER is and what it is used for

Protóxido de nitrógeno medicinal MESSER belongs to a group of medicines called general anesthetics.

Protóxido de nitrógeno medicinal MESSER is indicated for:

• Adjunct to general anesthesia, in combination with all intravenous or inhaled anesthetic agents.

• Adjunct to analgesia in the operating block or in the delivery room.

2. What you need to know before starting to use Medicinal Nitrous Oxide MESSER

Do not use Medicinal Nitrous Oxide MESSER

If you require ventilation with pure oxygen

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

In case of untreated air embolism (especially intracranial or pneumothorax, vesicular emphysema)

It must not be administered for longer than 24 hours

Warnings and precautions

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

Use of Medicinal Nitrous Oxide MESSER with other medicines

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

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

The combined use of 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 50% concentration of nitrous oxide in the inhaled mixture.

Driving and use of machines

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

Medicinal Nitrous Oxide MESSER contains no excipients.

3. How to use Medicinal Nitrous Oxide MESSER

Follow exactly the administration instructions for this medicine as 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 using a suitable system tailored to your needs, which ensures the delivery of the appropriate amount of oxygen.

The usual dose will vary depending on the circumstances for which medicinal nitrous oxide is used.

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

According to regulations, its use requires:

• A nitrous oxide-oxygen mixing device that ensures an FiO₂ always greater than or equal to 21%, allowing the possibility of achieving an FiO₂ of 100%, equipped with an anti-return valve and an alarm system in case of oxygen supply failure.

• Monitoring of FiO₂ in the inspired air, in the case of artificial ventilation.

In pregnant women, the administered concentration is 50%. Nitrous oxide must not be administered for longer than 24 hours due to its myelotoxicity.

For induction of anaesthesia, mixtures of 70% nitrous oxide and 30% v/v oxygen are administered. For maintenance, similar or lower mixtures are used.

As an analgesic, nitrous oxide is used at 25–50% v/v with oxygen.

The route of administration is by inhalation.

If you use more Medicinal Nitrous Oxide MESSER than you should:

In the case of 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 forget to use Medicinal Nitrous Oxide MESSER

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, Protóxido de nitrógeno medicinal Messer may have adverse effects, although not everyone will experience them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Inform your doctor as soon as possible if you experience any of the following symptoms:

• Nausea and vomiting
• Increased pressure and/or volume in the body's air-filled cavities
• Severe hematological disorders: megaloblastic anemia, leucopenia, agranulocytosis, during administration periods exceeding 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.

If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Medicinal Nitrous Oxide MESSER

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

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

All regulations concerning the handling of pressurized containers must be observed.

The following considerations apply to storage and transport:

Storage of cylinders:

Cylinders must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free of flammable materials, reserved for the storage of medical gases, and lockable.

Empty and full cylinders must be stored separately.

Storage of cylinders during use:

The cylinder must be placed in a location that protects it from impact or falling risks (such as a support with securing chains), heat or ignition sources, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

When not in use, cylinders must be kept with the valve closed. Excessive storage of cylinders should be avoided.

Transport of cylinders:

Cylinders must be transported in an upright position and with the aid of suitable equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling risks. Special care must be taken when attaching the pressure reducer to prevent accidental rupture.

During transport in vehicles, cylinders must be securely grouped together, and continuous ventilation of the vehicle is mandatory.

6. Contents of the pack and other information

Composition of Medicinal Nitrous Oxide MESSER

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

It contains no excipients.

Appearance of the product and contents of the container

The contents of the various pack sizes are as follows:

• 2 L cylinders containing 1.5 kg, providing 0.81 m³ of gas at a pressure of 1 bar and 15°C
• 3 L cylinders containing 2.25 kg, providing 1.22 m³ of gas at a pressure of 1 bar and 15°C
• 5 L cylinders containing 3.75 kg, providing 2.025 m³ of gas at a pressure of 1 bar and 15°C
• 10 L cylinders containing 7.5 kg, providing 4.05 m³ of gas at a pressure of 1 bar and 15°C
• 20 L cylinders containing 15 kg, providing 8.10 m³ of gas at a pressure of 1 bar and 15°C
• 40 L cylinders containing 30 kg, providing 16.2 m³ of gas at a pressure of 1 bar and 15°C
• 50 L cylinders containing 37.50 kg, providing 20.25 m³ of gas at a pressure of 1 bar and 15°C
• Blocks of 8 cylinders of 50 L containing 300 kg, providing 162 m³ of gas at a pressure of 1 bar and 15°C
• Blocks of 12 cylinders of 50 L containing 450 kg, providing 243.50 m³ of gas at a pressure of 1 bar and 15°C
• Blocks of 14 cylinders of 40 L containing 420 kg, providing 226.8 m³ of gas at a pressure of 1 bar and 15°C

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Messer Ibérica de Gases S.A.
Autovía Tarragona-Salou, Km 3.8
43480 Vilaseca (Tarragona)
Spain
[email protected]

Manufacturer:

Messer Belgium N.V.
Niewe Weg 1
B-2070 Zwijndrecht
Belgium

Instructions for use/handling for healthcare professionals

Nitrous oxide medicinal cylinders are intended exclusively for medical use.

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

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

• Always keep the cylinder in an upright position to prevent the risk of liquid projection, which could cause severe cryogenic-type burns (extreme cold). In case of burns, rinse thoroughly with water.
• Note that the gas pressure inside the cylinder remains constant (50 bar at 15°C), regardless of the residual liquid level, and does not reflect the remaining quantity. Only when the cylinder contains gas only, and exclusively at that moment, will the pressure drop rapidly. Only the weight of the cylinder allows estimation of its content during use.
• Check that equipment is in proper condition before use.
• Do not handle a cylinder whose valve is not protected by a cap.
• Handle equipment with clean, grease-free hands.
• Handle cylinders of 47 L and larger with appropriate handling gloves and safety footwear.
• Secure cylinders with suitable means (chains, hooks, etc.) to maintain them in an upright position and prevent accidental falls.
• Never force a cylinder into a holder if it does not fit easily.
• Never lift the cylinder by the valve.
• Use a specific G-type connector complying with standard NF E 29-650.
• Use a pressure-reducing valve with a flowmeter capable of withstanding a pressure at least 1.5 times the cylinder's maximum service pressure.
• For frames, use only pressure-reducing valves calibrated to at least 315 bar.
• Use flexible hoses for connection to wall outlets equipped with specific nitrous oxide medicinal gas check valves.
• Do not use intermediate connectors to adapt devices that do not fit together.
• Open the valve gradually.
• Never force the valve to open. Also, never open it fully.
• Purge the cylinder outlet connector before connecting the pressure-reducing valve to remove any dust. Keep the contact surfaces between the cylinder and the pressure-reducing valve clean.
• Never perform repeated pressurizations of the pressure-reducing valve.
• Never stand directly in front of the valve outlet; always stand to the side opposite the pressure-reducing valve, behind the cylinder and away from it. Never expose the patient to gas flows.
• Check the compatibility of materials in contact with medicinal nitrous oxide, especially using sealing gaskets for the pressure-reducing valve designed for this gas. Check the condition of the gaskets.
• Do not smoke.
• Do not bring flames near.
• Do not grease.
• In particular, never introduce this gas into equipment suspected of containing combustible materials, and especially greasy substances; never clean equipment containing this gas—such as valves, gaskets, linings, closures, and 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) on or near equipment.
• Close the cylinder valve after use, release the pressure from the pressure-reducing valve by leaving the flowmeter open, close the flowmeter, and then loosen the adjusting screw of the pressure-reducing valve.
• Do not attempt to repair a defective valve.
• Do not transfer pressurized gas from one cylinder to another.
• Do not over-tighten the clamp of the pressure-reducing valve-flowmeter, as this may damage the gasket.
• In case of leakage, close the supply valve showing the leak. Ventilate the area thoroughly and evacuate. Never use a cylinder showing a leak, and verify the proper functioning of the emergency system.
• If the valve is opened at a very high flow rate, causing frost formation on the pressure-reducing valve, do not use the cylinder and return it to the distributor.
• When ambient temperature is low or during high consumption causing cylinder cooling, flow may decrease or even stop due to insufficient pressure in the cylinder.
• Avoid using medicinal nitrous oxide cylinders at temperatures below 0°C to prevent pressure drop during intensive use.
• Store empty cylinders with valves closed to prevent possible corrosion in the presence of moisture.
• 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, expelling exhaled gases outdoors and avoiding areas where gases could accumulate. Before use, ensure the possibility of evacuating gases in case of accident or unexpected leakage.

Date of the most recent revision of this leaflet: July 2019.

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”