NITRIC OXIDE MESSER, medicinal gas for inhalation in a cylinder

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

Do not use Medical Nitrous Oxide MESSER

If you need ventilation with pure oxygen

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

If you have an undrained air embolism (especially intracranial or pneumothorax, vesicular emphysema)

It should not be administered for a period exceeding 24 hours

Warnings and precautions

Caution is recommended in patients with heart failure and in patients who have undergone ear and inner ear surgery.

Use of Medical Nitrous Oxide MESSER with other medicines

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

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

The combined use of nitrous oxide and methotrexate increases the side 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 concentration of 50% of nitrous oxide in the inhaled mixture.

Driving and using machines

It is recommended not to drive vehicles and not to use machinery for 24 hours after anesthesia in which nitrous oxide has been used

Medical Nitrous Oxide MESSERdoes not contain excipients.

3. How to use Medical Nitrous Oxide MESSER

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The doctor will determine the correct dose of nitrous oxide and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

The normal dose will vary depending on the circumstances for which Medical Nitrous Oxide MESSER is used.

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

According to regulations, its use requires:

• A nitrous oxide-oxygen mixer that ensures a FiO2 always greater than or equal to 21%, allowing for a FiO2 of 100%, equipped with an anti-backflow valve device and an alarm system in case of oxygen supply failure.

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

In pregnant women, the administered concentration is 50%. Nitrous oxide should not be administered for more than 24 hours due to its medullary toxicity.

For induction of anesthesia, mixtures of 70% nitrous oxide with 30% v/v oxygen are administered. For maintenance, similar or reduced mixtures are used.

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

The form of administration is by inhalation

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

In the event of an overdose, there is a risk of cyanosis and hypoxia. The administration of Medical Nitrous Oxide MESSER should be interrupted, and the patient should be ventilated (air or oxygen).

If you forget to use Medical Nitrous Oxide MESSER

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

4. Possible side effects

Like all medicines, Medical Nitrous Oxide MESSER can have side effects, although not everyone will experience them.

If you experience side effects, consult your doctor or pharmacist, even if they are side 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 of the body's air cavities
• Severe hematological disorders: megaloblastic anemia, leukopenia, agranulocytosis, in administration periods exceeding 24 hours.
• Euphoric effects
• Effects on the central nervous system: myeloneuropathies, neuropathies, and other adverse neurological reactions due to vitamin B12 deficiency.
• Generalized convulsions with unknown frequency.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Medical Nitrous Oxide MESSER

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

All regulations regarding the handling of pressure vessels must be followed.

Regarding storage and transportation, the following should be taken into account:

Storage of bottles:

Bottles should be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.

Empty bottles and full bottles should be stored separately.

Storage of bottles during use:

The bottle should be installed in a location that allows it to be protected from the risk of bumps and falls (such as a support with chains), from heat sources or ignition, from temperatures equal to or greater than 50°C, from combustible materials, and from the weather.

While waiting to be used, bottles should be kept with the valve closed. Excessive storage of bottles should be avoided.

Transportation of bottles:

Bottles should be transported in a vertical position and with the help of suitable material (such as a cart with chains, barriers, or rings) to protect them from the risk of bumps or falls. Special attention should be paid to securing the reducer to avoid accidental breakage.

During transportation in vehicles, bottles should be firmly grouped, and the vehicle should be permanently ventilated.

6. Package contents and additional information

Composition of Medical Nitrous Oxide MESSER

The active ingredient is Medical Nitrous Oxide. The concentration is greater than 98% by volume.

It does not contain excipients

Appearance of the product and package contents

The content of the different formats is as follows:

2L bottles containing 1.5 Kg and providing 0.81 m3 of gas at a pressure of 1 bar at 15°C

3L bottles containing 2.25 kg and providing 1.22 m3 of gas at a pressure of 1 bar at 15°C

5L bottles containing 3.75 kg and providing 2.025 m3 of gas at a pressure of 1 bar at 15°C

10L bottles containing 7.5 Kg and providing 4.05 m3 of gas at a pressure of 1 bar at 15°C

20L bottles containing 15 kg and providing 8.10 m3 of gas at a pressure of 1 bar at 15°C

40L bottles containing 30 Kg and providing 16.2 m3 of gas at a pressure of 1 bar at 15°C

50L bottles containing 37.50 Kg and providing 20.25 m3 of gas at a pressure of 1 bar at 15°C

Blocks of 8 bottles of 50L containing 300 kg and providing 162 m3 of gas at a pressure of 1 bar at 15°C

Blocks of 12 bottles of 50L containing 450 kg and providing 243.50 m3 of gas at a pressure of 1 bar at 15°C

Blocks of 14 bottles of 40L containing 420 Kg and providing 226.8 m3 of gas at a pressure of 1 bar at 15°C

Not all packages may be marketed.

Marketing authorization holder and manufacturer

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

Medical nitrous oxide bottles are exclusively reserved for medical use.

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

To avoid any incidents, it is necessary to strictly follow the following instructions:

• Always keep the bottle in a vertical position to avoid the risk of liquid projection, which would cause severe cryogenic burns (very cold). In case of burns, rinse abundantly with water.
• Take into account that the gas pressure in the bottle remains constant (50 bar at 15°C), regardless of the residual liquid level, and is not a reflection of the remaining quantity. When the bottle no longer contains liquid, and only then, the pressure will drop rapidly. Only the weight of the bottle allows estimating its contents during use.
• Check the correct condition of the devices before use.
• Do not handle a bottle whose valve is not protected with a tulip.
• Handle the material with clean, grease-free hands.
• Handle bottles of 47L or more with specific handling gloves and safety shoes.

• Secure the bottles with a suitable means (chains, hooks...), to keep them in a vertical position and avoid accidental falls.
• Never force a bottle into a support that fits with difficulty.
• Never lift the bottle by the valve.
• Use a specific type G connector conforming to standard NF E 29-650.
• Use a manoreducer with a flowmeter that can withstand a pressure at least 1.5 times the maximum service pressure of the bottle.
• In the case of frames, use only manoreducers graduated to at least 315 bar.
• Use connection hoses to wall outlets provided with specific nitrous oxide medical connectors.
• Do not use an intermediate connector to allow the connection of two devices that do not fit.
• Open the valve progressively.
• Never force the valve to open. Never open it fully.
• Purge the bottle outlet before connecting the manoreducer to eliminate dust that may be present. Keep the contact surfaces between the bottle and the manoreducer clean.
• Never perform multiple pressurizations of the manoreducer.
• Never position yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the bottle, and away from it. Never expose the patient to gas flows.
• Check the compatibility of materials in contact with medical nitrous oxide, using specific connection gaskets for this gas. Check the condition of the gaskets.
• Do not smoke.
• Do not bring a flame near.
• Do not grease.
• In particular, never introduce this gas into a device that may contain combustible materials, and above all, greasy materials; never clean devices that contain this gas, such as valves, gaskets, liners, closure devices, and circuits, with combustible products, and in particular, greasy substances.
• Do not apply greasy substances (vaseline, ointments...) to the patients' faces.
• Do not use aerosol generators (hair spray, deodorant...), solvents (alcohol, gasoline) on devices or near them.
• Close the bottle valve after use, let the pressure of the manoreducer drop by leaving the flowmeter open, close the flowmeter, and then loosen the manoreducer adjustment screw.
• Do not attempt to repair a faulty valve.
• Do not transfer gas under pressure from one bottle to another.
• Do not tighten the manoreducer-flowmeter clamp, as this may damage the gasket.
• In case of leakage, close the faulty valve. Ventilate the area very well and evacuate it. Never use a bottle with a leak, and check the correct functioning of the emergency system.
• In case of valve opening with a very strong flow, with frost formation on the manoreducer, do not use the bottle and return it to the distributor.
• When the ambient temperature is low or in case of high consumption that causes the bottle to cool, the flow may decrease or even stop due to insufficient pressure in the bottle.
• Avoid using medical nitrous oxide bottles at a temperature below 0°C to avoid a pressure drop in case of intensive use.
• Keep empty bottles with the valves closed to avoid possible corrosion in the presence of humidity.
• Never use medical nitrous oxide for leak 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 personnel exposure.
• Systematically ventilate the area of use, evacuating the exhaled gases to the outside and avoiding areas where they may accumulate. Before use, it is advisable to ensure the possibility of evacuating gases in case of an accident or unexpected leak.

Date of the last revision of this leaflet:July 2019.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”