NITROUS 98% V/V Pulmonary Inhalation

2. What you need to know before starting treatment with Nitrous Oxide Medicinal Messer

Do not use Nitrous Oxide Medicinal Messer:

• If you need ventilation with pure oxygen
• If you have undrained air embolisms, particularly intracranial or pneumothorax, bullous emphysema
• Do not use it for more than 24 hours continuously

Warnings and Precautions

• If you have heart failure, monitor your blood pressure to avoid hypotension

• If you are going to undergo ear surgery or surgery in adjacent air-filled areas

Using Nitrous Oxide Medicinal Messer with other medicines

Tell your doctor if you are taking, or have recently taken, any other medicine, including those obtained without a prescription

Nitrous oxide enhances the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphinics, halogenated), so the dosage of these should be reduced. You should also inform your doctor if you are taking medicines containing methotrexate (e.g., for rheumatoid arthritis)

Pregnancy, Breastfeeding, and Fertility

Pregnancy

During pregnancy, the concentration of nitrous oxide in the inhaled mixture should not exceed 50%

Obstetric Anesthesia:

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

Avoid using nitrous oxide in case of fetal distress

Obstetric Analgesia:

The use of nitrous oxide for this indication can only be done if a safety flowmeter is available to prevent the administration of nitrous oxide at a concentration greater than 50%

Breastfeeding

Consult your doctor before using the medicine

Driving and Using Machines

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

3. How to use Nitrous Oxide Medicinal Messer

Nitrous oxide medicinal is intended for exclusive hospital use

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

Your doctor will determine the necessary dose of nitrous oxide and it will be administered through a system suitable for your needs, ensuring the supply of the correct amount of oxygen

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 the available data

Common

• Nausea and vomiting
• Dizziness and feeling of intoxication

Uncommon

• Middle ear disorders
• Temporary increase in pressure and/or volume of the body's air cavities, normal or pathological
• Ocular hypertension
• Bradycardia
• Vertigo
• Euphoria, agitation

Rare

• Anxiety, hallucinations (psychodysleptic effects may occur in the absence of combination with another anesthetic), somnolence

Very Rare

• Malignant hyperthermia

• Frequency not knownSevere hematological disorders (megaloblastic anemia, agranulocytopenia, leukopenia) have been described for treatments lasting more than 24 hours
• Arrhythmia, heart failure
• Epilepsy, increased intracranial pressure
• Psychotic disorder, confusion, euphoric mood state
• Pneumothorax

• Headache, myelopathy, subacute combined degeneration of the spinal cord, polyneuropathy, generalized convulsions
• Respiratory depression
• Addiction

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of Nitrous Oxide Medicinal Messer

Keep this medicine out of the sight and reach of children

Do not use Nitrous Oxide Medicinal Messer after the expiration date

Cryogenic containers:

• Must be located outdoors in a clean area, without flammable materials, reserved for the storage of medicinal gases
• It is forbidden to smoke, grease equipment, and make fire in the area where the cryogenic containers are located
• Do not park in the area of the cryogenic containers
• Monitor the risk of asphyxiation
• Cryogenic containers must be protected from the risk of shock, particularly filling, emptying, and safety elements (valves, manometers), heat sources or ignition, temperatures above 50°C, and combustible materials
• The pressure inside the distribution pipes from the cryogenic container must not exceed 10 bar

6. Package Contents and Additional Information

Composition of Nitrous Oxide Medicinal Messer

The active ingredient is Nitrous Oxide, with a concentration greater than 98% v/v

It does not contain any excipients

Appearance of the Product and Package Contents

Cryogenic containers have different average capacities with the following volumes:

• A fixed cryogenic container of 3000 liters contains 3447 kg
• A fixed cryogenic container of 4000 liters contains 4340 kg
• A fixed cryogenic container of 7000 liters contains 7300 kg
• A fixed cryogenic container of 10000 liters contains 10470 kg
• A fixed cryogenic container of 21000 liters contains 21660 kg

Marketing Authorization Holder and Manufacturer

Messer Ibérica de Gases S.A.U

Autovía Tarragona-Salou, Km 3.8

43480 Vilaseca (Tarragona)

Spain

Manufacturer

Ijsfabriek Strombeek N.V

Broeckstraat 70 B-1860

Meise

Belgium

Date of the Last Revision of this Package Leaflet: March 2025

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

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This information is intended only for healthcare professionals:

Nitrous oxide is reserved for exclusive medical use

Nitrous oxide medicinal must be used exclusively in a mixture with medicinal oxygen; the oxygen concentration (FiO2) must never be less than 21%

To avoid accidents, the following guidelines must be respected:

• The projection of liquid could cause severe cryogenic burns (very cold). In case of burns, rinse abundantly with water
• Ventilate the area of use if possible
• Check the good condition of the materials before use
• Perform any manipulation of nitrous oxide containers wearing clean, adapted gloves and safety glasses, without any grease
• Never touch the cold or frosty parts of the material
• Handle the material with clean, grease-free hands
• Use a specific connector for nitrous oxide
• Use connection hoses to wall outlets with specific connections for nitrous oxide medicinal
• Do not use an intermediate connector that allows connecting two devices that do not fit
• Check the compatibility of materials in contact with nitrous oxide medicinal beforehand, in particular, use connection gaskets to the manoreducer intended for this gas. Check the condition of the gaskets
• Do not smoke, do not approach a flame, and do not grease

IMPORTANT:

• Never introduce this gas into a device that may contain combustible bodies, particularly fatty bodies
• Never clean the containers that contain this gas, valves, gaskets, closing devices, as well as circuits, with combustible products, particularly fatty bodies
• Do not apply greasy substances (vaseline, ointments, etc.) to the face of patients
• Do not use aerosol generators (hair spray, deodorants, etc.), 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 nitrous oxide medicinal at a temperature below 0°C to avoid a drop in pressure in case of intensive use
• Never use nitrous oxide medicinal for leak tests, for powering pneumatic equipment, and for blowing pipes
• The average exposure limit value (over 8 hours) to nitrous oxide is set at 25 ppm for exposure of personnel

Systematically ventilate the area of use, evacuating the exhaled gases to the outside and avoiding places where they could accumulate. It is advisable, before any use, to ensure the possibility of evacuating gases in case of an accident or unexpected leak