Nitrous oxide medicinal Air Liquide 98% V/V cryogenic medicinal gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nitrous Oxide Medicinal Air Liquide 98% v/v, medicinal cryogenic gas

Read the entire leaflet carefully before starting to use this medicine, as 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.
  • If you experience adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Leaflet contents

1. What Nitrous Oxide Medicinal Air Liquide is and what it is used for
2. What you need to know before using Nitrous Oxide Medicinal Air Liquide
3. How to use Nitrous Oxide Medicinal Air Liquide
4. Possible adverse effects
5. Storage of Nitrous Oxide Medicinal Air Liquide
6. Contents of the container and other information

1. What Óxido Nitroso Medicinal Air Liquide is and what it is used for

Medicinal Nitrous Oxide belongs to the group of general anesthetics (central nervous system) and is an inhalation gas.

This medicine is intended for hospital use only.

The use of this medicine is indicated in the following cases:

• As an adjunct to general anesthesia, in combination with all intravenous or inhaled anesthetic agents.
• As an adjunct to analgesia (pain relief) in the operating room or in the delivery room.

2. What you need to know before using Medicinal Nitrous Oxide Air Liquide

Do not use nitrous oxide:

• In patients requiring ventilation with 100% oxygen.
• Patients who have recently received an intraocular gas injection (such as SF6, C3F8, C2F6), as long as an intraocular gas bubble persists or within 3 months after the last intraocular gas injection. Expansion of an intraocular gas bubble by nitrous oxide may cause severe visual impairment (see Section 4).
• If you have pneumothorax (presence of air in the pleural space), air in the intracranial space, suffer from severe bullous emphysema (obstruction of the bronchi), have maxillofacial injuries, decompression sickness, after recent underwater diving, following air encephalography, or in cases of intestinal obstruction and head injuries with loss of consciousness.
• Should not be used for more than 24 hours or more frequently than every 4 days without medical supervision and hematological monitoring.
• If you have gas embolism, after recent underwater diving, if air has been injected into the epidural space to determine needle placement for epidural anesthesia, or during surgery on the middle ear, inner ear, or nasal sinuses.
• Any altered state of consciousness that prevents the patient from cooperating when nitrous oxide is used for analgesia.

Warnings and precautions

Consult your doctor before starting to use Medicinal Nitrous Oxide.

• Nitrous oxide is an oxidizing gas that supports and accelerates combustion.
• As with all anesthetic gases, adequate ventilation must be ensured at the site where Nitrous Oxide is used.
• Nitrous oxide must not be administered with less than 21% oxygen.
• Nitrous oxide is heavier than air and may accumulate in low-lying areas, creating a hazardous atmosphere.
• In patients with cardiac insufficiency, if hypotension (low blood pressure) or heart failure (the heart cannot pump sufficient blood to the body) occurs during nitrous oxide administration, discontinue administration immediately.
• In patients who have undergone nasal sinus or inner ear surgery.
• Prolonged and frequent use of nitrous oxide may cause serious blood disorders.
• Should not be used for more than a total of 24 hours or more frequently than every 4 days without specialized clinical supervision.
• Vitamin B12 levels should be assessed in patients with risk factors such as alcoholics, patients with anemia or gastric disorders, elderly patients, or those with poor or vegetarian diets.

Vitamin B12 levels should be evaluated in patients with risk factors for vitamin B12 deficiency prior to using nitrous oxide anesthesia. Risk factors include alcoholic patients, patients with anemia, atrophic gastritis, elderly individuals, those with vegetarian diets, or those taking medications that may interfere with Vitamin B12 and/or folate metabolism. Vitamin B12 supplementation should be given in cases of repeated or prolonged administration.

Neurological toxicity has occurred after a single exposure to nitrous oxide during general anesthesia in patients with undiagnosed subclinical vitamin B12 deficiency. Ear pain and/or middle ear disorders and/or tympanic membrane rupture may occur if the Eustachian tube is obstructed due to increased pressure in the tympanic cavity.

Patients diagnosed and/or at risk of intracranial hypertension should be monitored, as increased intracranial pressure has been observed during nitrous oxide administration in some patients with intracranial disorders.

Use of Nitrous Oxide with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Administration of nitrous oxide is contraindicated in patients in whom an intraocular gas bubble persists after receiving an intraocular gas injection and/or patients who have received a recent intraocular gas injection within the previous 3 months, as significant visual disturbances caused by expansion of the intraocular gas may occur.

Nitrous oxide potentiates the hypnotic effects (drowsiness, sleep) of central nervous system depressant drugs (intravenous or inhalational anesthetics, thiopental, benzodiazepines, opioids, halogenated agents, and psychotropic drugs); therefore, the doses of these drugs should be reduced when administered concurrently.

Medications that interfere with Vitamin B12 and/or folate metabolism may enhance the inactivation of Vitamin B12 by nitrous oxide.

Pregnancy, breastfeeding, and fertility:

Nitrous oxide may be used during pregnancy if clinically necessary.

When nitrous oxide is used close to delivery, newborns should be monitored for possible adverse effects.

Nitrous oxide may be used during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

3. How to use Nitrous Oxide Medicinal Air Liquide

Nitrous Oxide Medicinal is intended for hospital use only.

Nitrous oxide must only be administered in the operating theatre or in the delivery room, mixed with oxygen.

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

The physician will determine the required dose of nitrous oxide, which will be administered using a system appropriate to the patient's needs, ensuring the delivery of the correct amount of oxygen.

If you have been given more Nitrous Oxide than you should have:

In case of overdose, there is a risk of cyanosis (bluish discoloration of the skin and mucous membranes due to lack of oxygen in the blood) and hypoxia (lack of oxygen in the blood). In such cases, administration of nitrous oxide must be discontinued and the patient should be given air and oxygen.

If in doubt, consult your physician.

4. Possible adverse effects

Like all medicines, Nitrous Oxide Medicinal may cause adverse effects, although not everybody experiences them.

The likelihood of experiencing an adverse effect is described using the following categories:

Frequent (> 1/100 to < 1/10):

Gastrointestinal disorders: Nausea, vomiting.

Uncommon (> 1/1,000 to < 1/100):

Nervous system disorders: Paresthesia.

Psychiatric disorders: Euphoria.

Unknown (cannot be estimated from available data):

Nervous system disorders: Dizziness, myelopathies, neuropathies, increased intracranial pressure, generalized seizures.
Blood and lymphatic system disorders: Megaloblastic anaemia, pancytopenia (observed under predisposing conditions (cobalamin deficiency, substance abuse)), leucopenia/agranulocytosis (observed after very high and prolonged exposures during treatment for tetanus in the 1950s).

Eye disorders: Severe visual impairment (caused by expansion of intraocular gas).

Ear and labyrinth disorders: Ear pain, middle ear disorders, tympanic membrane rupture (in case of Eustachian tube obstruction).

Respiratory, thoracic and mediastinal disorders: Respiratory depression (in the newborn, when nitrous oxide is used during childbirth).

Metabolism and nutrition disorders: Vitamin B12 deficiency.

Psychiatric disorders: Disorientation.

Specific to analgesia:

Uncommon (> 1/1,000 to < 1/100):

Nervous system disorders: Excessive sedation.

Psychiatric disorders: Agitation, anxiety, hallucinations, dreams.

Unknown (cannot be estimated from available data):

Nervous system disorders: Headache.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines (Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano) at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Nitrous Oxide Air Liquide

Fixed containers:

• Must be installed outdoors in a clean area, free from flammable materials, and reserved exclusively for the storage of medicinal gases.
• Smoking, greasing equipment, and open flames are strictly prohibited in the area where the fixed containers are located.
• Parking is not permitted in the area of the fixed containers.
• The risk of asphyxiation must be monitored.
• Fixed containers must be protected from impact hazards, particularly affecting filling, emptying, and safety components (valves, pressure gauges), as well as from heat sources or ignition sources, temperatures exceeding 50°C, and combustible materials.
• The pressure within the distribution piping from the fixed container must not exceed 10 bar.

NOTE: Any theft or diversion of the product must be immediately reported to the authorities, the manufacturer, and the Spanish Agency for Medicines and Health Products.

6. Contents of the pack and other information

Composition of Nitrous Oxide Medicinal Air Liquide

• The active substance is nitrous oxide. Each dose contains 98% Medicinal Nitrous Oxide.
• It contains no other components (excipients).

Nature of the product and contents of the container

Fixed containers are fixed cryogenic tanks with the following volumes:

A fixed container of 3,000 litres contains 3,669 kg of gas
A fixed container of 3,135 litres contains 3,834 kg of gas
A fixed container of 3,200 litres contains 3,913 kg of gas
A fixed container of 3,424 litres contains 4,187 kg of gas
A fixed container of 3,600 litres contains 4,402 kg of gas
A fixed container of 7,761 litres contains 9,491 kg of gas
A fixed container of 9,970 litres contains 12,193 kg of gas
A fixed container of 9,900 litres contains 12,217 kg of gas
A fixed container of 10,000 litres contains 12,230 kg of gas

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AIR LIQUIDE Santé INTERNATIONAL
75 Quai d’Orsay
75341 PARIS Cedex 07
FRANCE

Manufacturer

AIR LIQUIDE Santé FRANCE
75 Quai d’Orsay
75341 PARIS Cedex 07
FRANCE

OR

S.E. de Carburos Metálicos S.A.
C/ Aragón, 300
08009 – Barcelona
SPAIN

OR

AIR LIQUIDE HEALTHCARE ESPAÑA, S.L.
P.I. El Sabinar, Parcela 19
50290 Épila, Zaragoza
SPAIN

Date of the most recent review 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.

Instructions for use and handling intended for healthcare professionals

To avoid accidents, the following safety instructions must be observed:

• Projection of liquid causes severe cryogenic burns (extremely cold). In case of burns, rinse thoroughly with water.

. Ventilate the area of use if possible.

. Check the condition of equipment before use.

. Perform any handling of nitrous oxide containers wearing clean gloves suitable for this purpose and protective goggles.

. Never touch cold or frosted parts of the equipment.

. Handle equipment with clean hands, free from grease.

. For fixed containers: use specific connectors for Medicinal Nitrous Oxide.

. Prior to use, verify compatibility of materials in contact with Medicinal Nitrous Oxide, particularly use connection washers designed for this gas. Check the condition of washers.

. Do not smoke, do not approach open flames, and do not apply grease.

IMPORTANT:

• Never introduce this gas into any apparatus that might contain flammable substances, particularly greasy materials.
• Never clean containers containing this gas, valves, washers, closure devices, or circuits with flammable products, particularly greasy substances.
• Do not apply greasy substances (vaseline, ointments, etc.) to patients' faces.
• Do not use aerosol generators (hairspray, deodorants, etc.) or solvents (alcohol, gasoline, etc.) on or near the equipment.

. 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 50 ppm for personnel exposure.
• Ensure systematic ventilation of the area of use, expelling exhaled gases outdoors and avoiding areas where gases could accumulate.

. Before any use, it is advisable to ensure that gases can be evacuated in case of accident or unexpected leakage.