Nitrous oxide medicinal Linde, 98.0% liquefied medicinal gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MEDICINAL NITROUS OXIDE LINDE,

98.0% liquefied medicinal gas

Nitrous Oxide

Read all of 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, ask your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What ÓXIDO NITROSO MEDICINAL LINDE is and what it is used for
2. What you need to know before using ÓXIDO NITROSO MEDICINAL LINDE
3. How to use ÓXIDO NITROSO MEDICINAL LINDE
4. Possible side effects
5. How to store ÓXIDO NITROSO MEDICINAL LINDE
6. Contents of the pack and other information

1. What OXIDO NITROSO MEDICINAL LINDE is and what it is used for

Nitrous Oxide is an inhalation gas belonging to the group of general anesthetics (nervous system and central).

This medicinal product is for hospital use only.

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 in the delivery room.

2. What you need to know before using Nitrous Oxide Medicinal Linde

Nitrous oxide is an oxidizing agent that supports and accelerates combustion.

Do not use Nitrous Oxide Medicinal Linde:

Inhalation of nitrous oxide may cause gas bubbles, and gases present in body cavities may expand due to increased diffusion of nitrous oxide. Therefore, do not use nitrous oxide:

• If you require ventilation with pure oxygen.

• 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 (the membrane surrounding the heart) due to injury or disease, e.g., due to smoking, or presence of air or gas bubbles in the body.

• Do not use for longer than 24 consecutive hours.

• If you have recently been diving and may be at risk of decompression sickness.

• If you have recently undergone cardiopulmonary bypass surgery.

• If you have abdominal gaseous distension.

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

  • If you present persistent signs of confusion, altered cognitive function, or other signs that could be related to increased intracranial pressure, since nitrous oxide may increase intracranial pressure.
  • If you have reduced level of consciousness or reduced ability to cooperate and follow instructions, as nitrous oxide may further reduce protective reflexes.
  • If you have an untreated deficiency of folic acid or vitamin B12, or have genetic disorders affecting the enzymatic system involved in vitamin metabolism, as the use of nitrous oxide could worsen such deficiency.

Take special care with Nitrous Oxide Medicinal Linde:

Also inform your doctor if you have or experience 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 a history of drug/medication abuse, because there is a high risk of developing dependence on nitrous oxide if taken repeatedly.

Your doctor will decide whether Nitrous Oxide Medicinal Liquefied Gas Linde can be used in your case.

Prolonged or repeated use of nitrous oxide may increase the risk of vitamin B12 deficiency, which could lead to bone marrow or nervous system damage. Your doctor may require blood tests before and after treatment to assess the potential consequences of vitamin B12 deficiency.

Using Nitrous Oxide Medicinal Linde with other medicines

Nitrous Oxide Medicinal Liquefied Gas Linde potentiates the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, opioids, halogenated agents); therefore, the dosage of these agents should be reduced.

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

If you are taking other medicines that affect the brain or brain functions, e.g., benzodiazepines (tranquilizers) or morphine, you must inform your doctor. Nitrous oxide may enhance the effects of these medicines. Nitrous oxide, when taken together with other sedatives or medicines affecting the central nervous system, increases the risk of adverse effects.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

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

• Obstetric anesthesia:

Due to its rapid passage across the fetoplacental barrier, administration of Nitrous Oxide Medicinal Linde should be discontinued if the time between induction of anesthesia and delivery of the fetus exceeds 20 minutes. Avoid using Nitrous Oxide Medicinal Liquefied Gas Linde in cases of fetal distress.

• Obstetric analgesia:

The use of Nitrous Oxide Medicinal Liquefied Gas Linde for this indication is only permitted if a safety flowmeter is available that prevents administration of nitrous oxide at concentrations exceeding 50%.

Breastfeeding

Consult your doctor before using this medicine.

Driving and using machines

It is recommended not to drive vehicles or operate machinery within 24 hours after anesthesia with nitrous oxide.

3. HOW TO USE MEDICINAL NITROUS OXIDE LINDE

The physician will determine the correct dose of nitrous oxide and will administer it to you using a system appropriate to your needs, which will ensure the delivery of the correct amount of oxygen.

During treatment with nitrous oxide, both you and the administration of this medicine 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 containing at least 21% oxygen to avoid the risk of hypoxia (oxygen deficiency). Nitrous oxide is typically used at doses ranging between 50% and 70% of the inhaled gas volume.

If you use more MEDICINAL NITROUS OXIDE LINDE than you should

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

4. Possible adverse effects

Like all medicines, Medicinal Nitrous Oxide Linde may cause adverse effects, although not everyone experiences them.

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

• Nausea and vomiting.
• Dizziness, mild headache, euphoria.
• Feeling of intoxication.

Uncommon adverse reactions (affects at least 1 in 1,000 but less than 1 in 100 patients):

• Sensation of pressure in the middle ear.
• Bloating, increased intestinal gas.

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

• Effects on nerve function, sensations of numbness or reduced strength or weakness, usually in the legs.

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

-Paraparesis

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

• Effects on nerve function, sensations of numbness and weakness, generally in the legs.
• Disorders of bone marrow and nervous functions, such as: Megaloblastic anemia (enlargement of the size of red blood cells), leukopenia (reduction in the number of white blood cells in the blood), polyneuropathy (peripheral nervous system disorders), myelopathy (spinal cord disorders), headache.
• Generalized seizures.
• Psychiatric disorders may also occur, such as psychosis, confusion, anxiety, addiction.
• Respiratory depression.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor.

5. Storage of MEDICINAL NITROUS OXIDE LINDE

Keep out of the sight and reach of children.

All regulations concerning the handling of pressurized containers must be observed. The following points must be taken into account regarding storage and transport:

Storage of cylinders:

• Cylinders must be stored in a well-ventilated or ventilated area, protected from adverse weather conditions, frost-free, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and locked with a key.
• Empty and full cylinders must be stored separately.
• Cylinders must be protected from risks of impact and falling, from sources of heat or ignition, from combustible materials, and from temperatures above 50 °C.
• At delivery by the manufacturer, cylinders must be equipped with an intact tamper-proof seal.
• Empty cylinders must be stored in an upright position with the valve closed to prevent any corrosion in the presence of moisture.

Storage of cylinders during use:

• Cylinders must be installed in a properly equipped area (with securing straps, etc.) to maintain them in an upright position.
• Cylinders must be protected against risks of impact or falling, sources of heat or ignition, and temperatures above 50 °C.
• When awaiting use, cylinders must be kept with the valve closed, and excessive storage of containers should be avoided.

Transport of cylinders:

• Cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from the risk of impact or falling, thereby preventing the risk of burns in case of valve opening.
• Particular attention must also be paid to securing the pressure regulator to prevent accidental breakage.
• During transport in vehicles, cylinders must be securely fastened and always kept in an upright position. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

Expiry date:

Do not use MEDICINAL NITROUS OXIDE LINDE after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

6. Package Contents and Additional Information

Composition of MEDICINAL NITROUS OXIDE LINDE:

• The active substance is: Nitrous Oxide (N₂O) at a concentration greater than 98.0% (v/v).
• It contains no excipients.

Appearance of the product and package contents:

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

• A 5-liter cylinder contains 3.75 kg and provides 2.1 m³ of gas at a pressure of 1 bar and 15°C.
• A 10-liter cylinder contains 7.5 kg and provides 4.1 m³ of gas at a pressure of 1 bar and 15°C.
• A 13-liter cylinder contains 10 kg and provides 5.4 m³ of gas at a pressure of 1 bar and 15°C.
• A 20-liter cylinder contains 15 kg and provides 8.1 m³ of gas at a pressure of 1 bar and 15°C.
• A 50-liter cylinder contains 37.5 kg and provides 20.3 m³ of gas at a pressure of 1 bar and 15°C.
• A manifold block of twelve 50-liter cylinders contains 450 kg and provides 243.6 m³ of gas at a pressure of 1 bar and 15°C.

Marketing Authorization Holder:

LINDE GAS ESPAÑA, S.A.U.

Camino de Liria, s/n,

46530 Puzol, Valencia, Spain

Telephone: 93.476.74.00 and 902.426.462

Manufacturer:

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.

Date of most recent revision of this leaflet: January 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS)

http://www.aemps.es

This information is intended exclusively for healthcare professionals

MEDICINAL NITROUS OXIDE LINDE liquefied medicinal gas is reserved for exclusive hospital use.

MEDICINAL NITROUS OXIDE LINDE must be used exclusively in mixture with medicinal Oxygen; the Oxygen concentration (FiO₂) must never be less than 21%.

Repeated exposure to or administration of nitrous oxide may lead to addiction. Healthcare professionals should exercise caution regarding occupational exposure to nitrous oxide.

Do not smoke, do not approach open flames, and do not apply grease.

To prevent accidents, the following safety instructions must be observed:

• Projection of liquid causes severe cold burns. In case of frostbite, rinse thoroughly with abundant water.
• Note that the gas pressure inside the cylinder remains constant (44 bar at 15°C), regardless of the residual liquid level. Only when the cylinder no longer contains gas—and only at that moment—does the pressure drop rapidly. Only the cylinder's weight allows estimation of its remaining content during use.
• Ventilate the area of use whenever possible.
• Check the condition of equipment before use.
• Perform any handling of MEDICINAL NITROUS OXIDE LINDE containers wearing clean, suitable gloves and protective goggles.
• Do not handle a cylinder if its valve is not protected by a cap.
• Handle cylinders with clean hands, free from grease.
• Handle cylinders with a capacity equal to or greater than 50 liters wearing clean gloves and safety footwear.
• Secure cylinders using appropriate means (chains, hooks, etc.) to keep them in an upright position and prevent falls.
• Never force a cylinder into a support if it fits with difficulty.
• Never lift the cylinder by the valve.
• Use a specific connector (coupling) for Nitrous Oxide when handling cylinders.
• Use a pressure-reducing valve with a flowmeter capable of withstanding a pressure at least 1.5 times the cylinder's maximum service pressure.
• Use flexible connection elements to wall outlets equipped with specific nozzles for Nitrous Oxide.
• Do not use intermediate connectors that allow the connection of incompatible devices.
• Open the valve gradually.
• Never force the valve to open.
• Purge the outlet connector of the cylinder before connecting the pressure-reducing valve to remove any possible dust particles.
• Never stand directly in front of the valve outlet; always stand on the side opposite the pressure-reducing valve, behind the cylinder and away from it. Never expose the patient directly to the gas flow.
• Verify material compatibility with Nitrous Oxide beforehand, particularly by using gaskets designed for this gas when connecting to the pressure-reducing valve. Check the condition of gaskets.

IMPORTANT:

• Never introduce this gas into any device suspected of containing combustible materials, especially greasy substances.
• Never clean containers containing this gas, valves, gaskets, closure devices, or circuits with flammable products, particularly greasy substances.
• Do not apply greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosol generators (hair spray, deodorants, etc.) or solvents (alcohol, gasoline, etc.) on or near the equipment.
• Close the cylinder valve after use.
• Never attempt to repair a defective valve.
• Never transfer gas from one cylinder to another.
• In case of leakage, close the valve exhibiting the leak.
• Never use a cylinder showing signs of leakage.
• If opening the valve results in high flow and frost formation, do not use the cylinder and contact the manufacturer.
• When ambient temperature is low or during high consumption causing cylinder cooling, the flow rate may decrease or even stop due to insufficient pressure inside the cylinder.
• Avoid using MEDICINAL NITROUS OXIDE LINDE cylinders at temperatures below 0°C to prevent pressure drop during intensive use.
• Store empty cylinders with the valve closed to prevent corrosion caused by moisture.
• Never use MEDICINAL NITROUS OXIDE LINDE for leak testing, powering pneumatic tools, or blowing through pipelines.
• The time-weighted average exposure limit (over 8 hours) to MEDICINAL NITROUS OXIDE LINDE is set at 25 ppm for personnel exposure.
• Systematically ventilate the area of use, evacuating exhaled gases to the outside and avoiding areas where gases could accumulate. It is advisable, prior to any use, to ensure the possibility of evacuating gases in case of accident or unexpected leakage.