Leaflet: information for the user

MEDICAL LINDE NITROUS OXIDE, 98.0% medicinal liquefied gas

Nitrous Oxide

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMEDICAL LINDE NITROUS OXIDEand what it is used for

2. What you need to know before starting to useMEDICAL LINDE NITROUS OXIDE

3. How to useMEDICAL LINDE NITROUS OXIDE

4. Possible side effects

5. Storage ofMEDICAL LINDE NITROUS OXIDE

6. Contents of the pack and additional information

MEDICINAL LINDE NITROSO OXIDE is an inhalation gas that belongs to the group of general anesthetics (nervous and central systems).

This medication is only for hospital use.

The treatment with MEDICINAL LINDE NITROSO 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 delivery room.

Nitrous Oxide is a combustible, allows and accelerates combustion.

Do not use Linde Medical Nitrous Oxide:

Inhaling nitrous oxide can cause gas bubbles and gases trapped in body cavities can expand due to increased diffusion of nitrous oxide. Therefore, do not use nitrous oxide:

- If you need pure oxygen ventilation.

- In patients with intraocular gas injection (e.g. SF6 or C3F8).

- If you have pneumothorax (air in the pleural cavity) or emphysema (bronchial obstruction), or have air in the pericardium (membrane surrounding the heart) due to injury or disease, e.g. due to tobacco, air, or gas bubbles in the body.

- Do not use it for more than 24 hours consecutively.

- If you have recently been engaging in scuba diving and may be at risk of decompression sickness.

- If you have recently undergone a cardiopulmonary bypass.

- If you have abdominal gas distension

- If you have severe heart failure (e.g. after cardiac surgery), as nitrous oxide could increase cardiac function alteration.

• If you present persistent signs of confusion, altered cognitive function, or other signs that may be related to increased intracranial pressure, as nitrous oxide could increase intracranial pressure.
• If you have a decreased level of consciousness or ability to collaborate and follow instructions, as nitrous oxide could decrease protective reflexes.
• If you have diagnosed folate acid deficiency or vitamin B12 deficiency, untreated or have genetic alterations of the enzymatic system related to vitamin metabolism, as the use of nitrous oxide could increase this deficiency.

Be especially careful with Linde Medical Nitrous Oxide:

Also inform your doctor if you have or present any of the following symptoms/signs:

- If you have ileus (intestinal obstruction) or heart failure.

- If you suffer from vitamin B12 deficiency.

-Ear discomfort, such as ear inflammation, as nitrous oxide could increase middle ear pressure.

- If you have or have had medication abuse because there is a high risk of generating dependence on nitrous oxide if you take it repeatedly.

Your doctor will decide when Linde Medical Nitrous Oxide Gas is possible in your case.

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

Use of Nitrous Oxide Medical Linde with other medications

Nitrous Oxide Medical Gas Licuado Linde potentiates the hypnotic effects of intravenous or inhalation anesthetics (thiopental, benzodiazepines, morphines, halogenated), so you should reduce the dosage of these.

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

If you are taking other medications that affect the brain or brain functions, e.g.benzodiazepines (tranquilizers) or morphine, you must inform your doctor. Nitrous oxide can increase the effects of these medications. Nitrous oxide, taken together with other sedatives or medications that affect the central nervous system, increases the risk of side effects.

You must also inform your doctor if you are taking medications with methotrexate (e.g. for rheumatoid arthritis), as nitrous oxide increases the side effects of these medications.

Pregnancy, lactation, and fertility

Pregnancy

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or nurse before using this medication.

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

-Obstetric anesthesia:

Due to the rapid transfer across the placental barrier, it is recommended to interrupt the administration of Linde Medical Nitrous Oxide if the time interval between the induction of anesthesia and fetal extraction exceeds 20 minutes. Avoid using Nitrous Oxide Medical Gas Licuado Linde in case of fetal distress.

-Obstetric analgesia:

The use of Nitrous Oxide Medical Gas Licuado Linde in this indication can only be made if a safety syringe is available that prevents the administration of nitrous oxide at a concentration above 50%.

Lactation

Consult with your doctor before using this medication.

Driving and using machines

It is recommended not to drive vehicles and not to use machines during the 24 hours following anesthesia with Nitrous Oxide.

The doctor will determine the correct dose of Nitrous Oxide and it will be administered through an appropriate system that will ensure the supply of the correct amount of Oxygen.

During treatment with nitrous oxide, you and the administration of this medication must be monitored to ensure that nitrous oxide is administered safely. After completing administration, you must be monitored by healthcare personnel until you have recovered.

Nitrous oxide is usually administered in a gas mixture that contains at least 21% oxygen to avoid the risk of hypoxia (oxygen deficiency). Nitrous oxide is usually used at doses ranging from 50 to 70% of the inhaled gas volume.

If you use more MEDICINAL LINDE NITROUS OXIDE than you should

There is a risk of cyanosis and hypoxia. Administration of MEDICINAL LINDE NITROUS OXIDE must be interrupted and the patient ventilated (air or Oxygen).

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

Frequent adverse reactions (at least 1 in 100, but less than 1 in 10 patients):

- Nausea and vomiting.

- Dizziness, mild headache, euphoria.

- Sense of intoxication.

Frequent adverse reactions (at least 1 in 1000, but less than 1 in 100 patients):

- Sense of pressure in the middle ear.

- Swelling, increase in intestinal gas.

Rare adverse reactions (at least 1 in 10,000, but less than 1 in 1,000)

• Effects on nervous function, numbness or decrease in strength or weakness, usually in the legs.

Very rare adverse reactions (at least 1 in 10,000 people experience them):

- Paraparesia

Adverse reactions of unknown frequency (cannot be estimated with available data):

- Effects on nervous function, numbness and weakness, generally in the legs.

- Bone marrow and nervous system disorders, such as: Megaloblastic anemia (increase in size of red blood cells), leukopenia (reduction in number of white blood cells), polyneuropathy (peripheral nervous system disorders), myelopathy (bone marrow disorders), headache

- Generalized seizures.

- Psychiatric disorders, such as psychosis, confusion, anxiety, addiction, may also be experienced.

- Respiratory depression

If you consider that some of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor.

Keep out of sight and reach of children.

All guidelines for handling pressurized containers must be followed. In relation to storage and transportation, the following must be taken into account:

Storage of the cylinders:

-The cylindersmust be stored in a well-ventilated or air-conditioned area, protected from the elements, shielded from frost, clean, free from flammable materials, reserved for the storage of medical gases, and locked.

-Empty and full cylindersmust be stored separately.

-The cylindersmust be protected from the risks of shocks and falls, heat sources or ignition, flammable materials, and temperatures above 122°F (50°C).

-At the time of delivery from the manufacturer, the cylindersmust be equipped with an intact seal of inviolability.

-Empty cylindersmust be stored in an upright position with the valve closed, to prevent any corrosion in the presence of moisture.

Storage of the cylinders during use:

-The cylindersmust be installed in a conditioned area with suitable material (with fixation belts, etc.) to maintain them in an upright position.

-The cylindersmust be protected against the risks of shocks or falls, heat sources or ignition, and temperatures above 122°F (50°C).

-Before use, the cylindersmust be kept with the valve closed, and excessive storage of containers must be avoided.

Transportation of the cylinders:

-The cylindersmust be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of impacts or falls, and to prevent burns in case of valve opening.

-Particular attention must also be paid to the fixation of the regulator to avoid accidental rupture.

-During transportation in vehicles, the cylindersmust be securely fastened, always in an upright position. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Expiration Date:

Do not use LINDEN MEDICAL NITROUS OXIDE after the expiration date appearing on the packaging. The expiration date is the last day of the month indicated.

Composition of MEDICAL NITROUS OXIDE LINDE:

- The active principle is: Nitrous Oxide (N2O) with a concentration greater than 98.0% (v/v).

- It does not contain excipients.

Appearance of the product and contents of the container:

This medication is packaged in cylindersat 44 bar pressure at 15°C. The cylinderscan be made of steel, compact steel, aluminum, or compact aluminum of the following volumes (not all container sizes are marketed):

- A 5-liter cylindercontains 3.75 Kg and provides 2.1 m3of gas at a pressure of 1 bar and 15°C.

- A 10-liter cylindercontains 7.5 Kg and provides 4.1 m3of gas at a pressure of 1 bar and 15°C.

- A 13-liter cylindercontains 10 Kg and provides 5.4 m3of gas at a pressure of 1 bar and 15°C.

- A 20-liter cylindercontains 15 Kg and provides 8.1 m3of gas at a pressure of 1 bar and 15°C.

- A 50-liter cylindercontains 37.5 Kg and provides 20.3 m3of gas at a pressure of 1 bar and 15°C.

- A block of twelve 50-liter cylinders contains 450 kg and provides 243.6 m3of gas at a pressure of 1 bar and 15°C.

Holder:

LINDE GAS ESPAÑA, S.A.U.

Camino de Liria, s/n,

46530 Puzol, Valencia, Spain

Phone: 93.476.74.00 and 902.426.462

Responsible for manufacturing:

LINDE GAS ESPAÑA, S.A.U.

P.I. Can Pí de Vilaroch. Avd. Antonio Gaudí, 151. Rubí-08191 Barcelona, Spain.

LINDE GAS ESPAÑA, S.A.U

Pol. Ind. Bañuelos. Ctra. Alcalá-Daganzo, km 3,8. C/ Haití 1, 28806 Alcalá de Henares. (MADRID)- Spain.

January 2020 date of the last review of this prospectus.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.es

This information is intended solely for healthcare professionals

The MEDICAL NITROUS OXIDE LINDE gas is reserved for exclusive hospital use.

The MEDICAL NITROUS OXIDE LINDE must be used exclusively in a mixture with Medical Oxygen, the oxygen concentration (FiO2) must never be less than 21%.

Repeated exposure or administration of nitrous oxide may lead to addiction. Healthcare professionals must be cautious with occupational exposure to nitrous oxide.

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

To avoid accidents, the following precautions will be respected:

-Liquid projection causes severe cold burns. In case of burn, abundantly rinse with water.

-Consider that the gas pressure in the cylinderremains constant (44 bar at 15°C) regardless of the residual liquid level. When the cylinderno longer contains gas, and only at that moment, the pressure drops rapidly. Only the weight of the cylinderallows estimating its current content.

-Ventilate the area of use if possible.

-Check the good condition of the materials before use.

-Perform any manipulation on ÓXIDO NITROSO MEDICINAL LINDE containers wearing clean gloves adapted to that use and protective glasses.

-Do not manipulate a cylinder whose valve is not protected by a tulip.

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

-Manipulate cylindersof equal or greater capacity than 50 liters wearing clean gloves and safety shoes.

-Hold the cylinderswith an appropriate means (chains, hooks, etc.) to keep them in a vertical position and prevent any fall.

-Never force the placement of a cylinderin a support where it enters with difficulty.

-Do not lift the cylinderby the valve.

-For cylinders, use a specific valve for nitrous oxide.

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

-Use flexible connection elements to wall outlets provided with specific nozzles for nitrous oxide.

-Do not use an intermediate valve that allows connecting two devices that do not fit.

-Open the valve gradually.

-Never force the valve to open.

-Purge the outlet valve of the cylinderbefore connecting the flow regulator to eliminate any possible dust particles.

-Never position yourself in front of the valve outlet, but always on the opposite side of the flow regulator, behind the cylinderand away from it. Never expose the patient to the gas flow.

-Verify the compatibility of the materials in contact with nitrous oxide beforehand, in particular use connection joints to the flow regulator intended for this gas. Check the condition of the joints.

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 that contain this gas, the valves, the joints, the closure devices, and the circuits.

• Never apply greasy substances (vaseline, ointments, etc.) to the patients' faces.

• Never use aerosol generators (lacquer, deodorants, etc.), solvents (alcohol, gasoline, etc.) on the material or in its vicinity.

• Close the valve of the cylinderafter use.

• Do not attempt to repair a faulty valve.

• Do not transfer gas from one cylinderto another.

• In case of leakage, close the valve with a defect in tightness.

• Never use a cylinderwith a tightness defect.

•In case of opening the valve with a high flow rate and formation of frost, do not use the bottle and contact the manufacturer.

• When the ambient temperature is low or in case of high consumption that causes the cylinderto cool down, the flow rate may decrease, even interrupt due to insufficient pressure in the cylinder.

• Avoid using ÓXIDO NITROSO MEDICINAL LINDE cylinders at a temperature below 0°C to prevent a pressure drop in case of intensive use.

• Store empty cylinders with the valve closed to prevent any corrosion due to the presence of humidity.

• Never use MEDICAL NITROUS OXIDE LINDE for leak testing, for the feeding of pneumatic tools, and for blowing pipes.

• The average exposure limit (for 8 hours) to MEDICAL NITROUS OXIDE LINDE is set at 25 ppm for occupational exposure of personnel.

• Perform systematic ventilation of the area of use, evacuating the exhaled gases to the outside and avoiding areas where they could accumulate. It is advisable, before any use, to ensure the possibility of evacuating the gases in case of an accident or unexpected leakage.