Label: information for the user

MESSER MEDICAL NITROGEN OXIDE, medical gas for inhalation in a bottle

Nitrous Oxide

Read this label carefully before starting to use the medication, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you and should not be given to others, even if they present the same symptoms of illness as you, as it may harm them.- If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this label.

1. What isMESSER MEDICAL NITROGEN OXIDEand for what it is used

2. What you need to know before starting to useMESSER MEDICAL NITROGEN OXIDE

3. How to useMESSER MEDICAL NITROGEN OXIDE

4. Possible adverse effects

5. Storage ofMESSER MEDICAL NITROGEN OXIDE

6. Contents of the container and additional information

Medical Nitrous Oxide MESSERbelongs to a group of medications called general anesthetics.

Medical Nitrous Oxide MESSERis indicated for:

-Adjunct to general anesthesia, in association with all anesthetic agents administered via intravenous or inhalation routes.

-Adjunct to analgesia in operative or delivery room settings.

Do not use Medical Nitrous Oxide MESSER

If you need pure oxygen ventilation

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

If you have an undrained air embolism (especially intracranial or pneumothorax, bullous 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 surgery of the breasts and the inner ear.

Use of Medical Nitrous Oxide MESSER with other medications

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

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

The combined use of nitrous oxide and methotrexate increases the side effects of this cytotoxic drug.

Pregnancy, lactation, and fertility

If you are pregnant or in a lactation period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines

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

Medical Nitrous Oxide MESSERdoes not contain excipients.

Follow exactly the administration instructions for this medication, as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will determine the correct dose of nitrous oxide and administer it through an appropriate system that will ensure the supply of the correct amount of oxygen.

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

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

According to the regulations, its use requires:

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

• Monitoring of the 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 myelotoxicity.

For anesthesia induction, 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 administration method is inhalation.

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

In the case of overdose, there is a risk of cyanosis and hypoxia. Administration of Medical Nitrous Oxide should be interrupted, and the patient should be ventilated (air or oxygen).

If you forgot to use Medical Nitrous Oxide MESSER

Do not take a double dose to compensate for the missed doses.

Like all medications, Messer's Medical Nitrogen Oxide, may have adverse effects, although not all people may experience them.

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

Notify 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-filled cavities
• Severe hematological disorders: megaloblastic anemia, leukopenia, agranulocytosis, in periods of administration 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 of unknown frequency.

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

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressure containers must be followed.

The following must be taken into account in relation to storage and transportation:

Storage of bottles:

Bottles must be stored in a well-ventilated or air-conditioned area, protected from the elements, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being locked.

Empty and full bottles must be stored separately.

Storage of bottles during use:

The bottle must be installed in a location that protects it from the risks of impacts and falls (such as a support with chain fixation), heat sources or ignition, temperatures equal to or greater than 50°C, combustible materials, and the elements.

Before use, bottles must be kept with the valve closed. Excessive storage of bottles must be avoided.

Transportation of bottles:

Bottles must be transported in an upright position and with the aid of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of impacts or falls. Special attention must be given to securing the reducer to prevent accidental ruptures.

During transportation in vehicles, bottles must be solidly grouped, with permanent ventilation of the vehicle being mandatory.

Composition of Medical Nitrogen Oxide MESSER

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

No excipients are present.

Appearance of the product and contents of the packaging

The contents of the different formats are 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 8-bottle blocks of 50L containing 300 kg and providing 162 m3 of gas at a pressure of 1 bar at 15°C 12-bottle blocks of 50L containing 450 kg and providing 243.50 m3 of gas at a pressure of 1 bar at 15°C 14-bottle blocks of 40L containing 420 kg and providing 226.8 m3 of gas at a pressure of 1 bar at 15°C

Not all packaging formats may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Messer Ibérica de gases S.A.

Autovía Tarragona- Salou, Km 3.8

43480 Vilaseca (Tarragona)

Spain

[email protected]

Responsible for manufacturing:

Messer Belgium N.V.

Niewe Weg 1

B-2070 Zwijndrecht

Belgium

Instructions for use/manipulation for healthcare professional

The nitrous oxide medical bottles are reserved exclusively for medical use.

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

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

• Always keep the bottle in a vertical position to avoid the risk of liquid projection, which would cause severe cryogenic burns. In case of burn, abundantly rinse 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 amount. When the bottle contains only gas, and only at that moment, the pressure will drop rapidly. Only the weight of the bottle allows estimating its content during use.
• Check the correct state of the equipment before use.
• Do not manipulate a bottle whose valve is not protected with a tulip.
• Manipulate the material with clean and grease-free hands.
• Manipulate 47L and larger bottles with specific handling gloves and safety shoes.

• Hold the bottles with an appropriate means (chains, hooks...), in order to keep them in a vertical position and prevent accidental falls.
• Never force a bottle into a support where it may enter with difficulty.
• Do not lift the bottle by the valve.
• Use a specific G-type valve conforming to the NF E 29-650 standard.
• Use a pressure reducer with a flowmeter that can admit a pressure at least equal to 1.5 times the maximum service pressure of the bottle.
• In the case of frames, use only graduated pressure reducers to at least 315 bar.
• Use flexible connections to wall outlets provided with specific counters for medical nitrogen oxide.
• • Do not use an intermediate valve to allow connecting two devices that do not fit.
  • Open the valve gradually.
  • Never force the valve to open. Do not open it either until the maximum.
  • Purge the outlet valve of the bottle before connecting the pressure reducer to eliminate any dust that may have accumulated. Keep the contact surfaces between the bottle and the pressure reducer clean.
  • Never perform multiple successive pressure settings on the pressure reducer.
  • Never stand in front of the outlet valve, but always on the opposite side of the pressure reducer, behind the bottle, and away from it. Never expose the patient to gas flows.
  • Check the compatibility of the materials in contact with medical nitrogen oxide beforehand, using special connection joints to the pressure reducer for this gas. Check the state of the joints.
  • Do not smoke.
  • Do not approach a flame.
  • Do not grease.
  • Especially, do not introduce this gas into an apparatus that may contain combustible bodies, and above all, fatty bodies; do not clean the apparatus containing this gas, such as valves, joints, linings, closure devices, and valves, as well as 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 (lacquer, deodorant...), solvents (alcohol, gasoline) on the equipment or near it.
  • Close the bottle valve after use, let the pressure of the pressure reducer drop while leaving the flowmeter open, close the flowmeter, and then loosen the adjustment screw of the pressure reducer.
  • Do not attempt to repair a defective valve.
  • Do not transfer gas under pressure from one bottle to another.
  • Do not tighten the pressure reducer-flowmeter clamp, as there is a risk of damaging the seal.
  • In case of leakage, close the faulty valve and ventilate the area well. Do not use a bottle that has a leak, and check the correct functioning of the backup system.
  • In case of opening the valve to a very high flow rate, with the formation of frost on the pressure reducer, 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 down, the flow rate may decrease or even stop due to insufficient pressure in the bottle.
  • Avoid using nitrous oxide medical bottles at a temperature below 0°C to avoid a drop in pressure in case of intensive use.
  • Keep empty bottles with closed valves to prevent corrosion in the presence of humidity.
  • Never use medical nitrogen oxide for leak testing, for powering pneumatic tools, or for blowing tubes.
  • The mean time limit for exposure (during 8 hours) to medical nitrogen oxide is established at 25 ppm for personnel exposure.
  • Perform systematic ventilation of the area of use, evacuating the expired gases to the outside and avoiding areas where they may accumulate. Before use, it is advisable to ensure the possibility of evacuating the gases in case of an accident or unexpected leakage.

  Last review date of this prospectus:July 2019.

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