NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH, 98%, MEDICINAL CRYOGENIC GAS

2. What you need to know before using NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH

Do not use NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH.

• If you need ventilation with pure oxygen.
• If there is a possibility of air or gas accumulation in the body. This may apply to cases of untreated pneumothorax ("lung collapse"), pulmonary bullous emphysema, or decompression sickness ("decompression syndrome").
• Do not use it for more than 24 hours in a row.

• If you regularly or constantly inhale medicinal oxygen.
• If a sudden obstruction occurs in the gastrointestinal system.
• If there is a possibility of increased intracranial pressure, characterized by sudden headache, blurred vision, increased cerebrospinal fluid pressure, signs of neurological loss, and loss of consciousness.
• If there are facial injuries in the area where the anesthesia mask is placed.
• After an injection of gas (e.g., SF6, C3F8) into the eye, it may cause an increase in eye volume and the possibility of causing blindness (the doctor should not use nitrous oxide medicinal until sufficient time has passed).
• If there is a vitamin B12 deficiency in the early stages of pregnancy.

Warnings and Precautions

• If you have heart failure, monitor your blood pressure to avoid a drop.
• If you are going to undergo ear surgery and adjacent air-filled spaces.

• If you have a vitamin B12 deficiency, as occurs in people with pernicious anemia (malignant form of anemia) or Crohn's disease (chronic enteric disease) or in vegetarians.
• If you have sickle cell anemia (a specific blood disease in which red blood cells have an abnormal shape).
• If you have received analgesia containing opium during delivery (the combination of this type of medication with nitrous oxide medicinal may cause loss of consciousness).
• After an injection into the eye (with another agent), sufficient time must pass before administering nitrous oxide medicinal, as otherwise, there is a risk of eye problems (including blindness).
• When benzodiazepines are administered at the same time (a specific group of medications with tranquilizing, soporific, and/or muscle relaxant properties), as loss of consciousness may occur.
• If you have received treatment with bleomycin (a medication administered in cancer treatment).

Please consult your doctor if you have or have had any of these situations.

Using NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

• It should be considered that nitrous oxide potentiates the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphine, halogenated). This allows for a reduction in doses.
• The action of certain muscle relaxants (such as pancuronium, vecuronium) increases the effect of nitrous oxide medicinal.
• The damage caused by sodium nitroprusside (a medication used to treat high blood pressure) and methotrexate (a medication used to treat cancer) increases because the action of vitamin B12 is neutralized by nitrous oxide medicinal.
• The damage caused by bleomycin (a medication used to treat cancer) in the lungs may increase if oxygen administration is increased (as occurs in treatment with nitrous oxide medicinal).

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 medication.

It is recommended not to exceed a concentration of 50% nitrous oxide in the inhaled mixture.

Pregnancy

Some data have indicated that short-term use of nitrous oxide during pregnancy does not pose a greater risk of congenital malformations. In isolated cases, nitrous oxide may cause respiratory problems

Breastfeeding

It is unknown whether nitrous oxide medicinal is excreted in breast milk. It is not necessary to interrupt breastfeeding after a short period of administration.

Driving and Using Machines

Do not drive vehicles or operate machinery within 24 hours after anesthesia in which nitrous oxide was used.

3. How to use NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH

For inhalation use.

This medication will be administered by a doctor and the correct dose will be established.

The doctor will determine the correct dose of NITROUS OXIDE MEDICINAL and administer it through a system suitable for your needs (for short-term use in pain relief or in combination with anesthetic medications) that ensures the supply of the correct amount of oxygen.

When used for pain relief, it should be used in combination with oxygen in the same proportion (50% nitrous oxide and 50% oxygen).

Nitrous oxide requires use in combination with oxygen so that the oxygen concentration is always equal to or greater than 21% and a device with an anti-backflow valve and an alarm system in case of oxygen supply failure is used.

If you use more NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH than you should:

Nitrous oxide administration will be interrupted and you will be ventilated with air or oxygen.

If you stop treatment with NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH

If you stop using nitrous oxide medicinal and oxygen medicinal, you may experience oxygen deficiency. To avoid this, you can temporarily be ventilated with 100% oxygen.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The observed side effects are as follows and have an unknown frequency (cannot be estimated from available data):

• Psychiatric disorders:

Euphoria (feeling of well-being), psychosis (mental disorder).

• Blood and lymphatic system disorders:

Severe blood disorders such as megaloblastic anemia (anemia with giant red blood cells) or agranulocytopenia (decrease in white blood cells) have been observed when administered for more than 24 hours.

• Nervous system disorders:

Decreased circulation in the brain and decreased glucose consumption by the brain. Psychotropic effects may occur even without administering other anesthetic medications. Spinal cord disorders, neuropathies, epilepsy, increased intracranial pressure, symptoms of paralysis in both legs with muscle cramps.

Unknown frequency: Generalized convulsions.

• Eye disorders:

Slowed eye movements, temporary increase in pressure and/or volume of the eye if nitrous oxide is administered after an injection of a gas-generating medication into the eye.

• Ear and labyrinth disorders:

Temporary increase in pressure and/or volume of the middle ear cavities.

• Cardiac disorders:

Arrhythmias, heart failure, increased blood pressure in the lungs, and hypotension in the body.

• Respiratory, thoracic, and mediastinal disorders:

Apnea (respiratory depression), air in the thoracic cavity, subcutaneous emphysema, and symptoms similar to a respiratory infection. Hypoxia (oxygen deficiency) lasting several minutes after nitrous oxide administration is stopped.

• Gastrointestinal disorders:

Nausea and vomiting (very frequent). Temporary increase in pressure and/or volume in the intestines and abdominal cavity.

• Hepatobiliary and pancreatic disorders:

Jaundice and increased liver enzyme concentration.

• Disorders related to temperature:

Decrease and/or intense increase in body temperature.

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 Pharmacovigilance System for Human Use Medications: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH

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

Do not use NITROUS OXIDE MEDICINAL after the expiration date stated on the packaging.

All regulations regarding the handling of pressure vessels must be followed, as well as the instructions for your specific equipment.

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

• Cryogenic containers, mobile, must be installed outdoors, in a clean area, without flammable materials, reserved for the storage of medical gases, and locked. Never light a fire, smoke, or grease. Also, do not park in the transfer area. The risks caused by overloading the atmosphere or clothing must be monitored and controlled.
• Cryogenic containers, mobile, must be protected from shocks, heat sources, or ignition, temperatures above 50°C, and flammable materials.
• Cryogenic containers, mobile, should never be laid down.

6. Package Contents and Additional Information

Composition of NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH.

The active ingredient of NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH, 98.0%, cryogenic medicinal gas, is nitrous oxide.

Appearance of the Product and Package Contents

NITROUS OXIDE MEDICINAL LIQUID OXYGEN HEALTH, 98%, cryogenic medicinal gas, is a cryogenic gas packaged in mobile cryogenic containers with a capacity of 20,000 L, in liters of water.

Marketing Authorization Holder

OXYGEN HEALTH, S.A.

Pere IV, 453.

08020 Barcelona

Manufacturer

OXYGEN HEALTH

Pere IV, 453.

08020 Barcelona

Date of the Last Revision of this Package Leaflet: January 2020

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

This information is intended only for healthcare professionals.

Instructions for Use/Handling

• Do not smoke.
• Do not approach a flame.
• Do not grease.

Primarily, never introduce this gas into a device that may contain combustible bodies, and especially greasy bodies; never clean with combustible products, and especially greasy products, as the devices contain this gas, nor the keys, gaskets, linings, closing devices, and valves.

The cryogenic containers of nitrous oxide medicinal liquid are exclusively reserved for medical use

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

• Check the correct condition of the devices before use.
• Do not grease the patients' faces with greasy products (vaseline, ointments...).
• Handle the devices with clean and grease-free hands.
• Do not use aerosol generators (lacquer, deodorants...), solvents (alcohol, gasoline...) in the devices or near them.
• In case of a leak, close the valve or feeding circuit valve that has a leak. Never use a container that has a leak and check the proper functioning of the auxiliary system.
• Perform any handling of nitrous oxide containers with clean, suitable gloves for this use and protective glasses.
• Never touch the cold or frozen parts of the devices.

• In case of cryogenic burns, rinse abundantly with water.
• Use specific fittings for nitrous oxide.
• Mobile cryogenic containers: during the use of passage flexibles, never exceed the maximum service pressure; do not subject the flexible to a radius of curvature that is too small; never leave the flexible on the floor; monitor the condition of the external sleeve; and never grease the flexible.
• If clothing becomes saturated with nitrous oxide, move away from the source of nitrous oxide liquid and areas that present risks of inflammation. Also, remove the clothing.
• Do not use intermediate fittings to connect two devices that do not fit.
• Mobile cryogenic container: open the valve or valve progressively.
• Provide safety devices against over-pressures in each nitrous oxide circuit where there is a risk of liquid being trapped between two valves.
• Use flexible connection elements in wall outlets, equipped with specific nozzles for nitrous oxide.