Prospect: information for the user

Nitrous OxideMedicinal Air Liquide 98% v/v, medicinal cryogenic gas

Read this prospect carefully before starting to take this medication because it contains important information for you.

• Keep this prospect as you may need to read it again.
• • If you have any doubts, consult your doctor.
  • If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

1. What is Nitrous Oxide Medicinal Air Liquide and how it is used

2. What you need to know before starting to use 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 additional information

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

This medication is only for hospital use.

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

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

• Adjuvant to analgesia (pain relief) in the operating room or delivery room

No use óxido nitroso:

• In patients who require oxygen ventilation at 100%.
• Patients who have recently received an intraocular injection of gas (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 can cause severe visual deterioration (see Section 4).
• If you have pneumothorax (air in the lung space), if you have air in the intracranial space, if you have severe bullous emphysema (obstruction of the bronchi), if you have maxillofacial injuries, decompression sickness, after recent underwater immersion, after performing an air encephalogram, or in case of intestinal obstruction and after head injuries with loss of consciousness.
• Do not use for more than 24 hours or more than 4 days in frequency, without medical supervision and hematological monitoring.
• If you have gas embolism, after recent underwater immersion, if air has been injected into the epidural space to determine the placement of the needle for epidural anesthesia, or during middle ear, inner ear, and nasal sinus surgery.
• Any altered state of consciousness that prevents the patient from cooperating when using nitrous oxide in analgesia

Warnings and precautions

Consult your doctor before starting to use nitrous oxide Medicinal.

• Nitrous oxide is a combustible gas, which facilitates and accelerates combustion.
• As with all anesthetic gases, good ventilation is necessary in the place of use of Nitrous Oxide.
• Do not administer nitrous oxide with less than 21% oxygen.
• Nitrous oxide is heavier than air, it can accumulate in low areas and make the atmosphere hazardous.
• In patients with heart failure, if hypotension (low blood pressure) or heart failure (the heart cannot pump enough blood to the body) occurs during nitrous oxide administration, stop administering the gas immediately.
• In patients who have undergone nasal and inner ear surgery.
• Prolonged and frequent use of nitrous oxide can cause severe blood disorders.
• Do not use for more than a total of 24 hours or more than 4 days in frequency without specialized clinical supervision.
• The levels of vitamin B12 should be evaluated in patients with risk factors such as alcoholic patients, patients with anemia, or patients with gastrointestinal problems, elderly patients, or patients with a poor diet or vegetarians.

Vitamin B12 levels should be evaluated in patients with risk factors of vitamin B12 deficiency before using nitrous oxide anesthesia. Risk factors include alcoholic patients, patients with anemia, gastric atrophy, elderly patients, and those with a vegetarian diet or who have used medication that may interfere with vitamin B12 and/or folate metabolism. Vitamin B12 supplements should be given in case of repeated or prolonged administration.

In patients with undiagnosed subclinical vitamin B12 deficiency, neurological toxicity has occurred after a single exposure to nitrous oxide during general anesthesia. Ear pain, and/or middle ear disorders, and/or eardrum rupture may occur in case of Eustachian tube obstruction due to increased pressure in the tympanic cavity.

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

Use of Nitrous Oxide with other medications

Inform your doctor that you are using, have recently used, or may need to use any other medication.

Administration of nitrous oxide is contraindicated in patients with persistent intraocular gas bubbles after receiving an intraocular injection of gas and/or patients who have received a recent intraocular injection of gas within the last 3 months, as important visual disturbances may occur due to expansion of the intraocular gas bubble.

Nitrous oxide potentiates the hypnotic effects (drowsiness, sleep) of central nervous system depressants (intravenous or inhaled anesthetics, thiopental, benzodiazepines, morphines, halogenated, and psychotropics), so the dose of these should be reduced when administered simultaneously.

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

Pregnancy, lactation, and fertility:

Nitrous oxide can be used during pregnancy if clinically necessary.

When nitrous oxide is used near birth, newborns should be monitored for possible adverse effects.

Nitrous oxide can be used during lactation.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using the medication.

Nitrous OxideMedicinal isexclusively for hospital use.

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

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

The doctor will determine the necessary dose of nitrous oxide, which will be administered through an appropriate system that will ensure the supply of the correct amount of oxygen.

If you have been administered moreNitrous Oxidethan you should:

In case of overdose, there is a risk of cyanosis (blue discoloration of the skin and mucous membranes due to lack of oxygen in the blood) and hypoxia (lack of oxygen in the blood). In these cases, discontinue the administration of nitrous oxide and administer air and oxygen to the patient.

In case of doubt, ask your doctor.

Like all medications, Medical Nitrous Oxide can produce adverse effects, although not all people will experience them.

The possibility of presenting an adverse effect is described using the following categories:

Frequent (> 1/100 to <1

Gastrointestinal disorders: Nausea, vomiting.

Rare (> 1/1,000 to <1

Nervous system disorders: Paresthesia

Mental and behavioral disorders: Euphoria

Unknown (cannot be estimated from available data):

Nervous system disorders: Dizziness, myelopathies, neuropathies, increased intracranial pressure, generalized convulsions.
Blood and lymphatic system disorders: Megaloblastic anemia, pancytopenia (observed in predisposed circumstances (cobalamin deficiency, substance abuse)), leukopenia/agranulocytosis (observed after high and prolonged exposure to tetanus treatment in the 1950s).

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

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

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

Metabolic and nutritional disorders: Vitamin B12 deficiency.

Mental and behavioral disorders: Disorientation.

Specific to analgesia:

Rare (>1/1,000 to <1

Nervous system disorders: Excessive sedation

Mental and behavioral disorders: Agitation, anxiety, hallucinations, dreams.

Unknown (cannot be estimated from available data):

Nervous system disorders: Headache.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through thenational notification systemSpanish Medicines Agency Pharmacovigilance System: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Fixed Containers:

• Must be installed outdoors in a clean area, free from flammable materials, reserved for the storage of medicinal gases.
• Smoking, lubricating equipment, and fire are strictly prohibited in the area where the fixed containers are located.
• Vehicle parking is not allowed in the area of the fixed containers.
• The risk of asphyxiation must be monitored.
• Fixed containers must be protected from the risks 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 piping from the fixed container must not exceed 10 bars.

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

Composition ofNitrous OxideMedicinal Air Liquide

- The active principle is nitrous oxide. Each dose contains 98% nitrous oxide Medicinal.

- It does not contain other components (excipients).

Aspect of the product and contents of the packaging

The fixed containers are fixed cryogenic containers of the following volumes:

A fixed container of 3,000 liters contains 3,669 kg of gas

A fixed container of 3,135 liters contains 3,834 kg of gas

A fixed container of 3,200 liters contains 3,913 kg of gas

A fixed container of 3,424 liters contains 4,187 kg of gas

A fixed container of 3,600 liters contains 4,402 kg of gas

A fixed container of 7,761 liters contains 9,491 kg of gas

A fixed container of 9,970 liters contains 12,193 kg of gas

A fixed container of 9,900 liters contains 12,217 kg of gas

A fixed container of 10,000 liters contains 12,230 kg of gas

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AIR LIQUIDE SantéINTERNATIONAL

75 Quai d’Orsay

75341 PARIS Cedex 07

FRANCE

Responsible for manufacturing

AIR LIQUIDE SantéFRANCE

75 Quai d’Orsay

75341 PARIS Cedex 07

FRANCE

Ó

S.E. de Carburos Metálicos S.A.

C/ Aragón, 300

08009 – Barcelona

SPAIN

Ó

AIR LIQUIDE HEALTHCARE ESPAÑA, S.L.

P.I. El sabinar, Parcela 19

50290 Épila. Zaragoza

SPAIN

Last review date of this prospectus:July 2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

Instructions for use and handling directed to the healthcare professional

To avoid accidents, the following guidelines will be respected:

• The projection of liquid causes severe cryogenic burns (very cold). In case of burn, rinse abundantly with water.

. Ventilate if possible the place of use.

. Check the good condition of the materials before use.

. Perform any manipulation on nitrous oxide containers wearing clean gloves adapted to that use and protective glasses.

. Never touch the cold or frosted parts of the material.

. Manipulate the material with clean and grease-free hands.

. For fixed containers: use specific regulators for nitrous oxide Medicinal.

. Verify beforehand the compatibility of the materials in contact with nitrous oxide Medicinal, in particular use connection joints at the pressure reducer intended for this gas. Check the condition of the joints.

.Do not smoke, do not approach a flame and do not lubricate.

IMPORTANT:

• Never introduce this gas into an apparatus that may be suspected of containing combustible bodies and in particular fatty bodies.

• Never clean with combustible products and in particular fatty bodies, the containers containing this gas, valves, joints, closure devices, as well as circuits.

• Do not apply greasy substances (vaseline, ointments, etc.) to the face of patients.

• Do not use aerosol generators (lacquer, deodorants, etc.), solvents (alcohol, gasoline, etc.) on the material or in its vicinity.

. Do not use nitrous oxide Medicinal for leak tests, for the feeding of pneumatic tools and for blowing pipes.

• The median limit value of exposure (during 8 hours) to nitrous oxide is set at 50 ppm for the exposure of personnel.

• Perform systematic ventilation of the place of use, evacuating the expired gases to the outside and avoiding places where they could accumulate.

. It is advisable, before any use, to ensure the possibility of evacuating the gases in case of accident or unforeseen leak.