Prospect: information for the patient

OXIDO NITROSO MEDICINAL GAS OXIGEN SALUD, 98.0 %, medicinal liquefied gas

Nitrous oxide

Read this prospect carefully before starting to use the medication, as 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 or pharmacist.

- This medication has been prescribed only to you and should not be given to other people even if they have the same symptoms as you, as it may harm them.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is ÓXIDO NITROSO MEDICINAL GAS OXIGEN SALUD and for what it is used

2. What you need to know before starting to use ÓXIDO NITROSO MEDICINAL GAS OXIGEN SALUD

3. How to use ÓXIDO NITROSO MEDICINAL GAS OXIGEN SALUD

4. Possible adverse effects

5. Conservation of ÓXIDO NITROSO MEDICINAL GAS OXIGEN SALUD

6. Contents of the package and additional information

Nitrous oxide is a liquefied gas for inhalation. Nitrous oxide treatment is indicated in the following cases:

- Adjuvant to general anesthesia, in association with all anesthetic agents administered intravenously or by inhalation.

- Adjuvant to analgesia in the operating room or in the delivery room.

Do not use Medical Nitrous Oxide Gas Oxygen Health.

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

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

Warnings and Precautions

• If you have heart failure, monitor that you do not have a drop in blood pressure.
• If you are to be surgically intervened in the ear and adjacent air areas.

• If you have a vitamin B12 deficiency, as occurs in people with pernicious anemia (a malignant form of anemia) or Crohn's disease (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 analgesia containing opium was administered during childbirth (the combination of this type of medication with nitrous oxide may cause loss of consciousness).
• After an injection in the eye (with another agent), a sufficient time should have passed before administering nitrous oxide, 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-relaxing properties), as it may cause loss of consciousness.
• If you have received bleomycin treatment (a medication administered in cancer treatment).
• If you suffer or have suffered from addiction to medications/drugs because there is a high risk of generating dependence on nitrous oxide if you take it repeatedly. Your doctor will decide if nitrous oxide treatment is possible in your case.

The prolonged or repeated use of nitrous oxide may increase the risk of vitamin B12 deficiency, which may trigger 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 present or have presented any of these situations.

Use of Nitrous Oxide Medical Gas Oxygen Health with other medications

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

• 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.
• 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.
• The damage caused by bleomycin (a medication used to treat cancer) in the lungs may increase if oxygen administration is increased (as occurs in nitrous oxide treatment).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 the 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 in newborns. Nitrous oxide medical gas should only be used during pregnancy in strictly necessary cases. Frequent or prolonged use should be avoided.

Breastfeeding

The excretion of nitrous oxide medical gas in breast milk is unknown. It is not necessary to interrupt breastfeeding after a short period of administration.

Driving and using machines

Do not drive vehicles and do not use machinery in the 24 hours following anesthesia in which nitrous oxide was used.

For inhalation use.

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

The doctor will determine the correct dose of Medical Nitrous Oxide and administer it through an appropriate system for your needs (for short-term use in pain relief or in combination with anesthetic medications) that will ensure the supply of the correct amount of oxygen.

When used for pain relief, it should be used in combination with oxygen at 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 that a device with a backflow valve and an alarm system in case of oxygen supply failure is used.

If you use more Medical Nitrous Oxide Gas Oxygen than you should:

The administration of nitrous oxide will be interrupted and the area will be ventilated with air or oxygen.

If you interrupt treatment with Medical Nitrous Oxide Gas Oxygen

If you interrupt the use of medical nitrous oxide and oxygen, you may experience oxygen deficiency. To prevent this, temporarily ventilate the patient with 100% oxygen.

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

Like all medications, this medication may cause adverse effects, although not all people may experience them.

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

• Mental disorders:

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

• Blood and lymphatic system disorders:

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

• Nervous system disorders:

Decreased cerebral circulation and decreased glucose consumption by the brain. Psychodelic 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 has been administered after an injection of a gas-producing medication in the eye.

• Ear and labyrinth disorders:

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

• Cardiac disorders:

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

• Respiratory, thoracic, and mediastinal disorders:

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

• Gastrointestinal disorders:

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

• Hepatobiliary and pancreatic disorders:

Icterus and increased concentration of liver enzymes.

• Disorders related to temperature:

Intense decrease and/or increase in body temperature.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Nitrous Oxide Medicinal after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

All regulations related to the handling of pressure vessels and the instructions of your equipment must be followed.

In relation to storage and transportation, the following must be taken into account:

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

Cylinder storage within the storage room:

Cylinders must be stored in a well-ventilated or air-conditioned area, protected from the elements, sheltered from frost, clean, free from flammable materials, reserved for the storage of medical gases, and locked with a key. Full and empty cylinders must be stored separately. Cylinders must be protected from shock and impact, heat sources or ignition, flammable materials, weather conditions, and temperatures above 50°C.

At delivery from the manufacturer, cylinders must be provided with an intact inviolability guarantee system. Empty cylinders must be stored in a vertical position and with the valve closed, to prevent any type of corrosion in the presence of humidity.

Cylinder storage in use:

Cylinders must be installed in a conditioned location with an appropriate system (type of suspension hook, and with chain fixation), to maintain them in a vertical position. The cylinder must be protected from shock and impact, heat sources or ignition, and temperatures above 50°C.

While not in use, cylinders must be kept with the valves closed, taking care to avoid excessive storage.

Cylinder transportation.

Cylinders must be transported in a vertical position, and securely fastened with an appropriate material (type of cart provided with chains or rings), to protect them from shock and impact, in order to avoid the risk of burns in case of valve opening. Additionally, great care must be taken with the fixation of the regulator, in order to avoid accidental rupture.

Composition of MEDICAL NITROUS OXIDE GAS OXYGEN HEALTH.

The active principle of MEDICAL NITROUS OXIDE GAS OXYGEN HEALTH, 98.0%, medicinal liquefied gas is nitrous oxide.

Aspect of the product and contents of the packaging

TheMedicinal Nitrous Oxide Gas OXYGEN Healthis an inhalation gas that is packaged in cartridges at 50 bars of pressure at 15°C.

Thecartridges can be made of steel, compact steel, aluminum, or compact aluminum of the following volumes:

Holder of the marketing authorization

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143.

08174 Sant cugat del Vallès, Barcelona

Responsible for manufacturing

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 review of this prospectus: May 2019

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

--------------------------------------------------------------------------------------------------------------------This information is intended solely for healthcare professionals

Instructions for use / handling

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

- Do not smoke.

- Do not approach a flame.

- Do not lubricate.

The nitrous oxide medicinal cartridges are reserved exclusively for medical use.

Nitrous oxide medicinal should be used exclusively in a mixture with medicinal oxygen, the oxygen concentration should never be less than 21%.

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

- Always keep the cartridge in a vertical position, to avoid the risk of liquid projection, which would cause severe cryogenic burns (very cold). In case of burn, abundantly clarify with water.

- Take into account that the gas pressure in the cartridge remains constant (50 bar at 15°C), regardless of the level of residual liquid, and is not a reflection of the amount remaining. When the cartridge no longer contains gas, and only at that moment, the pressure will drop rapidly. Only the weight of the cartridge allows estimating its content during use.

- Check the correct state of the equipment before use.

- Do not handle a cartridge whose key is not protected by a cap or a protective wrapper.

- Handle the equipment with clean hands and no grease.

- Handle cartridges of 4.7 l and more with proprietary handling gloves and safety shoes.

- Hold the cartridges with an appropriate means (chains, hooks...), in order to keep them in a vertical position and avoid sudden falls.

- Never force a cartridge into a support in which it enters with difficulty.

- Never lift the cartridge by the key.

- Use a specific G-type regulator in accordance with the NF E 29-650 standard.

- Use a flow regulator with a flowmeter that can admit a pressure at least equal to 1.5 times the maximum service pressure of the cartridge.

- In the case of frames, use only flow regulators graduated at least to 315 bar.

- Use flexible connections to the wall outlets provided with specific seals for nitrous oxide medicinal.

- Do not use intermediate regulators to allow connecting two devices that do not fit.

- Open the key or valve gradually.

- Never force the key to open it. Do not open it either at full speed.

- Purge the outlet regulator of the cartridge before connecting the flow regulator to eliminate any powder that may have accumulated. Keep the contact surfaces between the cartridge and the flow regulator clean.

- Never proceed with several successive pressure settings of the flow regulator.

- Never stand in front of the key outlet, but always on the opposite side to the flow regulator, behind the cartridge and away from it. Never expose the patient to gas flows.

- Check the compatibility of the materials in contact with nitrous oxide medicinal beforehand, using special seals for the flow regulator intended for this gas. Check the state of the seals.

- In particular, never introduce this gas into an apparatus that may contain combustible bodies, and above all, fatty bodies; never clean the equipment containing this gas, such as keys, seals, linings, closing devices and valves, as well as circuits, with combustible products, and in particular, greasy substances.

- Do not grease the face of the patients.

- Do not use aerosol generators (lacquer, deodorant...), solvents (alcohol, gasoline) on the equipment or near it.

- Close the key of the cartridge after use, let the pressure of the flow regulator drop, leaving the flowmeter open, close the flowmeter and then loosen the adjustment screw of the flow regulator.

- Do not attempt to repair a defective key.

- Do not transfer gas at pressure from one cartridge to another.

- Do not tighten the pinch of the flow regulator-flowmeter, as there is a risk of damaging the seal.

- In case of leak, close the key or valve that presents a leak of tightness. Ventilate the room well and evacuate it. Never use a cartridge that presents a leak of tightness, and check the correct functioning of the auxiliary system.

- In case of opening the key at a very high flow rate, with the formation of frost on the flow regulator, do not use the cartridge and return it to the pharmacy.

- When the ambient temperature is low or in case of high consumption that causes the cooling of the cartridge, the flow may decrease, even interrupt, as a result of insufficient pressure in the cartridge.

- Avoid using nitrous oxide medicinal cartridges at a temperature below 0°C, to avoid a drop in pressure in case of intensive use.

- Store empty cartridges with closed keys and empty frames with closed valves (to avoid possible corrosion in the presence of moisture).

- Never use nitrous oxide medicinal for leak tests, for the feeding of pneumatic tools, and for blowing pipes.

- The median exposure limit value (during 8 hours) to nitrous oxide is set at 25 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. Before use, it is advisable to ensure the possibility of evacuating the gases in case of accident or unexpected leak