Oxido nitroso medicinal lÍquido oxigen salud, 98%, gas criogÉnico medicinal

Label: Information for the Patient

OXIDIZED NITROGEN MEDICAL LIQUID OXYGEN HEALTH, 98.0 %, MEDICAL CRYOGENIC GAS

Oxidized Nitrogen

Read this label carefully before starting to use the medication, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

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

1. What is OXIDIZED NITROGEN MEDICAL LIQUID OXYGEN HEALTH and how it is used

2. What you need to know before starting to use OXIDIZED NITROGEN MEDICAL LIQUID OXYGEN HEALTH

3. How to use OXIDIZED NITROGEN MEDICAL LIQUID OXYGEN HEALTH

4. Possible adverse effects

5. Storage of OXIDIZED NITROGEN MEDICAL LIQUID OXYGEN HEALTH

6. Contents of the package and additional information

Nitrous oxide is a cryogenic gas for inhalation. Treatment with nitrous oxide 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 Liquid Nitrous Oxide for Health.

• If you need 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”), 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 there is a sudden obstruction 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 medical 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 operated on 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 (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 analgesia containing opium was administered during childbirth (the combination of this type of medication with medical nitrous oxide may cause loss of consciousness).
• After an injection in the eye (with another agent), a sufficient amount of time should pass before administering medical 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).

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

Use of Medical Liquid Nitrous Oxide for Health with Other Medications

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

• Consider 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 medical 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 medical 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 treatment with medical nitrous oxide).

Pregnancy, Lactation, 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. Medical nitrous oxide should only be used during pregnancy in strictly necessary cases. Frequent or prolonged use should be avoided.

Lactation

The excretion of medical nitrous oxide 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 medical 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 MEDICINAL LIQUID OXIDE NITROSO 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% oxide nitroso and 50% oxygen).

MEDICINAL LIQUID OXIDE NITROSO requires use in combination with oxygen so that the oxygen concentration is always equal to or greater than 21% and that a device equipped with a backflow valve and an alarm system in case of oxygen supply failure is used.

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

The administration of oxide nitroso will be interrupted and ventilation will be done with air or oxygen.

If you interrupt treatment with MEDICINAL LIQUID OXIDE NITROSO OXYGEN HEALTH

If you interrupt the use of MEDICINAL LIQUID OXIDE NITROSO 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Mental health disorders:

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

• Blood and lymphatic system disorders:

Severe blood alterations such as megaloblastic anemia (anemia with giant red blood cells) or agranulocytosis (decrease in white blood cells) have been observed 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.

Unknown frequency: Generalized convulsions.

• 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.

• Temperature-related disorders:

Intense decrease and/or increase in body temperature.

Reporting of side effects

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

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

Do not useMedicinal Nitrous Oxideafter the expiration date that appears on the packaging.

All guidelines for handling pressure containers and specific equipment instructions must be followed.

The following must be taken into account regarding storage and transportation:

• Cryogenic mobile containers must be installed outdoors, in a clean area, free from flammable materials, reserved for medical gas storage, and locked. In no case should fire be lit, smoking or lubrication be allowed. They should not be parked in the transfer area. Risks caused by overpressure in the atmosphere or clothing must be monitored and controlled.
• Cryogenic mobile containers must be protected from shocks, heat sources or ignition, temperatures above 50°C, and combustible materials.
• Cryogenic mobile containers must never be tilted.

Composition of MEDICAL LIQUID OXYGEN NITROSO HEALTH.

The active principle of MEDICAL LIQUID OXYGEN NITROSO HEALTH, 98.0%, medicinal cryogenic gas is nitrous oxide.

Aspect of the product and contents of the packaging

TheMedical Nitrous OxideLiquid Oxygen Salud, 98%, medicinal cryogenic gas is a cryogenic gas that is packaged in mobile cryogenic containers with a capacity of 20,000 L, in liters of water.

Holder of the marketing authorization

OXIGEN SALUD, S.A.

Pere IV, 453.

08020 Barcelona

Responsible for manufacturing

OXIGEN SALUD

Pere IV, 453.

08020 Barcelona

Date of the last review of this prospectus: January 2020

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

- Do not smoke.

- Do not approach a flame.

- Do not lubricate.

Primarily, never introduce this gas into an apparatus that may be suspected of containing combustible bodies and, especially, fatty bodies; never clean with combustible products and, especially, with fatty bodies, as the apparatus contain this gas, nor the keys, the joints, the linings, the closure devices and the valves.

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

To avoid any incident, it is necessary to respect the following instructions:

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

• In case of cryogenic burn, abundantly rinse with water.
• Use specific racers for nitrous oxide
• Cryogenic mobile containers: during the use of the flexible connections, never exceed the maximum service pressure; do not subject the flexible to a too small curvature radius; do not leave the flexible on the floor; supervise the state of the external cover; and do not lubricate the flexible.
• If the clothing becomes saturated with nitrous oxide, move away from the nitrous oxide liquid source and from areas that present a risk of ignition. Remove the clothing as well.
• Do not use intermediate racers for connecting devices that do not fit.
• Cryogenic mobile containers: open the valve or valve gradually.
• 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, provided with specific nozzles for nitrous oxide.