PATIENT INFORMATION LEAFLET

MEDICAL LINDE NITROUS OXIDE, 98.0%, cryogenic medicinal gas in a fixed cryogenic container

Nitrous Oxide

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 is MEDICAL LINDE NITROUS OXIDE and what is it used for

2. What you need to know before you start using MEDICAL LINDE NITROUS OXIDE

3. How to use MEDICAL LINDE NITROUS OXIDE

4. Possible side effects

5. Storage of MEDICAL 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

(Central and nervous system).

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 via intravenous or inhalation routes.

Adjuvant to analgesia in the operating room or delivery room.

Nitrous Oxide is a combustible, allows and accelerates combustion.

Do not use Linde Nitrous Oxide Medical :

Inhaling nitrous oxide can cause gas bubbles and gases trapped in the body cavities can expand due to an increase in nitrous oxide diffusion. 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), 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 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 a deficiency of folic acid or vitamin B12, untreated or have genetic alterations of the enzyme system related to vitamin metabolism, as the use of nitrous oxide could increase this deficiency.

Be especially careful with Linde Nitrous Oxide Medical :

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, as there is a high risk of generating dependence on nitrous oxide if you take it repeatedly.

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

The 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. Your doctor may require blood tests before and after treatment with the aim of evaluating the consequences of a possible vitamin B12 deficiency.

Use of Linde Nitrous Oxide Medical with other medications

Nitrous Oxide Medical Liquid 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 acquired 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 should 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

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.

Pregnancy

During pregnancy, it is recommended not to exceed a concentration of 50% 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 Nitrous Oxide Medical Liquid if the time between the induction of anesthesia and fetal extraction exceeds 20 minutes. Avoid the use of Linde Nitrous Oxide Medical Liquid in case of fetal distress.

- Obstetric analgesia:

The use of Linde Nitrous Oxide Medical Liquid in this indication can only be carried out if a safety syringe is available that prevents the administration of nitrous oxide at a concentration higher than 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 prevent 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.

- Feeling of intoxication.

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

- Feeling 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, feeling of 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, sensations of 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 (affections of the peripheral nervous system), 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 this medication out of the sight and reach of children.

-Cryogenic containers must be installed in clean, well-ventilated areas free from flammable materials.

-The storage of medicinal gases must be separate from gases intended for other uses.

-Cryogenic containers must be protected from ignition sources, heat, combustible materials, and even static discharges.

-Cryogenic containers must be protected from the risks of shocks, impacts, or falls.

-No parking should be allowed in the area where cryogenic containers are located.

Expiration Date:

Do not use Medicinal Nitrous Oxide LINDEN after the expiration date:

6 months from the date of the last filling of the cryogenic container.

Composition of MEDICAL NITROUS OXIDE LINDE:

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

- It does not contain excipients.

Appearance of the product and contents of the container:

The cryogenic fixed containers are stainless steel cryogenic tanks of various capacities. The geometric capacity of each fixed cryogenic container is shown in liters and its correspondence in m3 of gas at 1 bar and 15°C:

All container sizes are not marketed

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.

Date of the last review of this prospectus:January 2020

The detailed and updated information of 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

MEDICAL NITROUS OXIDE LINDE is reserved for exclusive hospital use.

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 OIL.

To avoid any incidents, the following instructions must be strictly respected:

- Verify the good condition of the material before its use.

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

- Use protective glasses and clean gloves when handling the container.

- Do not touch the cold or frosty parts.

- In case of cryogenic burn, rinse with plenty of water.

- If the clothing is saturated with Nitrous Oxide, move away from the Nitrous Oxide source and from areas that may pose a risk of ignition, and remove the clothing.

- Open the valve of the cryogenic containers gradually.

- Never exceed the maximum service pressure.

- Use specific regulators for Nitrous Oxide.

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

- Do not subject the flexible hose to a too small curvature. Do not leave the flexible hose on the floor.

- Provide safety devices against overpressures in the Nitrous Oxide circuits where there is a risk of accumulating liquid between two valves.

- In case of a leak, close the valve with a leak and check that the emergency device is activated.

IMPORTANT:

-Never introduce this liquid into an apparatus that may be suspected of containing combustible bodies, and in particular, greasy bodies.

-Never clean with combustible products, and in particular, greasy bodies, the containers containing this liquid, the valves, the joints, the closure devices, as well as the circuits.

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

-Do not use aerosol generators (lacquer, deodorants, etc.), solvents (alcohol, gasoline, etc.) on the material, or in its vicinity.

-Close the valve of the container after use.

-Do not attempt to repair a faulty valve.

-Do not transfer liquid from one container to another.

-In case of a leak, close the valve with a leak.

-Do not use a container with a leak.

-The mean 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 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 leak.