NITROUS OXIDE MEDICAL GAS OXYGEN HEALTH, 98%, LIQUEFIED MEDICAL GAS

Introduction

Package Leaflet: Information for the Patient

NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD, 98.0%, Liquid Medicinal Gas

Nitrous Oxide

Read the entire package leaflet carefully before starting to use the medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD and what is it used for
2. What you need to know before starting to use NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD
3. How to use NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD
4. Possible side effects
5. Storage of NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD
6. Package Contents and Additional Information

1. What is NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD and what is it used for

Nitrous oxide is a liquid gas for inhalation. Treatment with nitrous oxide is indicated in the following cases:

• As an adjunct to general anesthesia, in combination with all anesthetic agents administered intravenously or by inhalation.
• As an adjunct to analgesia in the operating room or delivery room.

2. What you need to know before using NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD

Do not use NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD.

• 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 vesicular emphysema, or decompression sickness ("decompression syndrome").
• Do not use it for more than 24 hours consecutively.

• 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 severe 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 a gas injection (e.g., SF6, C3F8) into the eye, it may cause an increase in eye volume and the possibility of 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 areas.

• If you have a vitamin B12 deficiency, as occurs in people with pernicious anemia (a malignant form of anemia) or Crohn's disease (a chronic intestinal 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 childbirth (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 should pass before administering nitrous oxide medicinal, as otherwise, there is a risk of eye problems (including blindness).
• When benzodiazepines are administered simultaneously (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 used in cancer treatment).
• If you have a history of drug addiction, as there is a high risk of dependence on nitrous oxide if taken repeatedly. Your doctor will decide if treatment with nitrous oxide is possible in your case.

The prolonged or repeated use of nitrous oxide may increase the risk of vitamin B12 deficiency, which can cause damage to the bone marrow or nervous system. Your doctor may require a blood test before and after treatment to evaluate the consequences of a possible vitamin B12 deficiency.

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

Using NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD 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 for 24 hours after anesthesia in which nitrous oxide was used.

3. How to use NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD

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 GAS OXIGEN SALUD than you should:

The administration of nitrous oxide will be interrupted, and you will be ventilated with air or oxygen.

If you stop treatment with NITROUS OXIDE MEDICINAL GAS OXIGEN SALUD

If you stop using nitrous oxide medicinal and oxygen medicinal, you may experience a lack of oxygen. To avoid this, you can be temporarily 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 the 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.

Generalized convulsions with an unknown frequency.

• 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 (lack of oxygen) lasting several minutes after stopping nitrous oxide administration.

• 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.

Unknown frequency (frequency cannot be estimated from the available data)

• Addiction
• Effects on nervous system function, sensation of numbness and weakness, usually in the legs.

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 GAS OXIGEN SALUD

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 after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

All regulations regarding the handling of pressure vessels and the instructions of your particular equipment must be followed.

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

As with all liquid gases, full cylinders should always be kept in a vertical position, with the valves closed.

Storage of cylinders in the warehouse:

Cylinders should be stored in a well-ventilated or aired area, protected from the weather, frost, clean, without flammable materials, reserved for the storage of medical gases, and locked. Full and empty cylinders should be stored separately. Cylinders should be protected from shock and fall hazards, heat sources or ignition, flammable materials, weather conditions, and temperatures above 50°C.

Upon delivery by the manufacturer, cylinders should be equipped with an intact tamper-evident system. Empty cylinders should be kept in a vertical position and with the valve closed to avoid any corrosion in the presence of moisture.

Storage of cylinders in use:

Cylinders should be installed in a conditioned location with a suitable system (e.g., a retaining fork and fixing chains) to keep them in a vertical position. The cylinder should be protected from shock and fall hazards, heat sources or ignition, and temperatures above 50°C. While not in use, cylinders should be kept with the valves closed, avoiding excessive storage.

Transportation of cylinders.

Cylinders should be transported in a vertical position and securely fastened with suitable material (e.g., a cart equipped with chains or rings) to protect them from shock and fall hazards, in order to avoid a burn risk in case of valve opening. Additionally, great care should be taken with the fixation of the manifold reducer to avoid accidental rupture risks.

6. Container Content and Additional Information

Composition of MEDICAL NITROUS OXIDE GAS OXIGEN SALUD.

The active ingredient of MEDICAL NITROUS OXIDE GAS OXIGEN SALUD, 98.0%, liquefied medicinal gas is nitrous oxide.

Product Appearance and Container Content

The MEDICAL NITROUS OXIDE GAS OXIGEN SALUDis an inhalation gas packaged in cylinders at 50 bar pressure at 15°C.

The cylinders can be made of steel, compact steel, aluminum, or compact aluminum with the following volumes:

Marketing Authorization Holder

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143.

08174 Sant Cugat del Vallès, Barcelona

Manufacturer

OXIGEN SALUD

Pere IV, 453.

08020 Barcelona

OXIGEN SALUD

Polígono Industrial Madrigal del Monte

Calle A, Parcela 63

09320 Madrigal del Monte, Burgos

Date of the Last Revision of this Prospectus: May 2019

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

The administration or repeated exposure to nitrous oxide may lead to addiction. Precautions should be taken in healthcare professionals with occupational exposure to nitrous oxide.

• Do not smoke.
• Do not bring a flame near.
• Do not grease.

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

Medical nitrous oxide should be used exclusively in a mixture with medical oxygen, and the oxygen concentration should never be less than 21%.

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

• Always keep the cylinder in a vertical position to avoid the risk of liquid projection, which could cause severe cryogenic burns (extreme cold). In case of burns, rinse abundantly with water.
• Be aware that the gas pressure in the cylinder remains constant (50 bar at 15°C), regardless of the residual liquid level, and is not a reflection of the remaining quantity. When the cylinder no longer contains gas, and only at that moment, the pressure will drop rapidly. Only the weight of the cylinder allows estimation of its content during use.
• Check the correct condition of the devices before use.
• Do not handle a cylinder whose valve is not protected by a cap or protective covering.
• Handle devices with clean, grease-free hands.
• Handle cylinders of 4.7 liters or more with specific handling gloves and safety shoes.
• Hold the cylinders with a suitable means (chains, hooks...) to keep them in a vertical position and avoid unexpected falls.
• Never force a cylinder into a support that fits with difficulty.
• Never lift the cylinder by the valve.
• Use a specific type G connector according to the NF E 29-650 standard.
• Use a manometer with a flowmeter that can withstand a pressure at least 1.5 times the maximum service pressure of the cylinder.
• In the case of frames, use only manometers graduated to at least 315 bar.
• Use connection hoses to the wall outlets provided with specific nitrous oxide medicinal gas fittings.
• Never use an intermediate connector to allow coupling of two devices that do not fit.
• Open the valve or tap progressively.
• Never force the valve to open. Never open it fully.
• Purge the cylinder outlet connector before connecting the manometer to eliminate any dust that may be present. Keep the contact surfaces between the cylinder and the manometer clean.
• Never perform multiple successive pressurizations of the manometer.
• Never position yourself in front of the valve outlet, but always on the opposite side of the manometer, behind the cylinder, and away from it. Never expose the patient to gas flows.
• Check the compatibility of materials in contact with medical nitrous oxide, using specific connection gaskets for the manometer intended for this gas. Check the condition of the gaskets.
• In particular, never introduce this gas into a device that may contain combustible materials, especially fatty substances; never clean devices that contain this gas, such as valves, gaskets, liners, closing devices, and circuits, with combustible products, and especially fatty substances.
• Never apply fatty substances (vaseline, ointments...) to the patient's face.
• Never use aerosol generators (lacquer, deodorant...), solvents (alcohol, gasoline) on devices or near them.
• Close the cylinder valve after use, let the manometer pressure drop by leaving the flowmeter open, close the flowmeter, and then loosen the manometer adjustment screw.
• Never attempt to repair a faulty valve.
• Never transfer gas under pressure from one cylinder to another.
• Never tighten the manometer-flowmeter clamp, as this may damage the gasket.
• In case of a leak, close the valve or supply tap that shows a leak. Ventilate the area very well and evacuate it. Never use a cylinder with a leak, and check the correct functioning of the auxiliary system.
• In case of opening the valve to a very high flow rate, with frost formation on the manometer, do not use the cylinder and return it to the pharmacy.
• When the ambient temperature is low or in case of high consumption that causes cooling of the cylinder, the flow rate may decrease or even stop due to insufficient pressure in the cylinder.
• Avoid using medical nitrous oxide cylinders at a temperature below 0°C to prevent a pressure drop in case of intensive use.
• Store empty cylinders with closed valves and empty frames with closed valves (to prevent possible corrosion in the presence of humidity).
• Never use medical nitrous oxide for leak tests, for powering pneumatic tools, and for blowing pipes.
• The average exposure limit value (over 8 hours) to nitrous oxide is set at 25 ppm for personnel exposure.
• Perform systematic ventilation of the use area, evacuating exhaled gases to the outside and avoiding areas where they could accumulate. Before use, it is advisable to ensure the possibility of evacuating gases in case of an accident or unexpected leak.