Nitrous oxide medicinal liquid Linde, 98%, medicinal cryogenic gas in mobile cryogenic container

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

MEDICINAL NITROUS OXIDE LINDE,

98.0% medicinal cryogenic gas in mobile cryogenic container

Nitrous Oxide

Read the entire leaflet carefully before you start using this medicine.

• 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 adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects.
5. Storage of 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 intended for hospital use only.

Nitrous oxide treatment 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 MEDICINAL NITROUS OXIDE LINDE

Nitrous oxide is an oxidizer that supports and accelerates combustion.

Do not use MEDICINAL NITROUS OXIDE LINDE:

Inhalation of nitrous oxide may cause gas bubbles to expand, 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), emphysema (bronchial obstruction), or air in the pericardium (the membrane surrounding the heart) due to injury or disease, e.g., due to smoking, air, or gas bubbles in the body.
• Do not use for longer than 24 consecutive hours.
• If you have recently engaged in diving activities and may be at risk of decompression sickness.
• If you have recently undergone cardiopulmonary bypass surgery.
• If you have abdominal gas distension.
• If you have severe heart failure (e.g., after cardiac surgery), as nitrous oxide could worsen cardiac dysfunction.
  • If you show persistent signs of confusion, altered cognitive function, or other signs possibly related to increased intracranial pressure, since nitrous oxide could increase intracranial pressure.
  • If you have reduced level of consciousness or impaired 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 related to vitamin metabolism, as the use of nitrous oxide could worsen such deficiency.

Take special care with MEDICINAL NITROUS OXIDE 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, since 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 MEDICINAL NITROUS OXIDE LINDE is appropriate for you.

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

Use of MEDICINAL LIQUID NITROUS OXIDE with other medicines

MEDICINAL LIQUID NITROUS OXIDE LINDE enhances the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, opioids, halogenated agents), so the dosage of these agents should be reduced.

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained 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 may enhance the effects of these medications. Nitrous oxide, when taken together with other sedatives or medications affecting the central nervous system, increases the risk of side effects.

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

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

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

• Obstetric anesthesia:

Due to its rapid passage across the fetoplacental barrier, administration of MEDICINAL NITROUS OXIDE LINDE should be discontinued if the time between induction of anesthesia and delivery of the fetus exceeds 20 minutes. Avoid use of MEDICINAL NITROUS OXIDE LINDE in cases of fetal distress.

• Obstetric analgesia:

The use of MEDICINAL NITROUS OXIDE LINDE for this indication is only permissible if a safety flowmeter is available that prevents administration of nitrous oxide at a concentration exceeding 50%.

Breastfeeding

Consult your doctor before using this medicine.

Driving and use of machines

It is recommended not to drive or operate machinery for 24 hours following 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 suitable system tailored to your needs, which will ensure the delivery of the appropriate amount of oxygen.

During treatment with nitrous oxide, 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 fully recovered.

Nitrous oxide is normally 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 ventilated (with air or oxygen).

4. Possible adverse effects

Like all medicines, MEDICINAL NITROUS OXIDE LINDE may produce 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.
• Swelling, 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 the available data):

• Effects on nerve function, sensations of numbness and weakness, generally in the legs.
• Disorders of the bone marrow and nervous functions, such as: Megaloblastic anemia (increased size of red blood cells), leucopenia (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 this medicine out of the sight and reach of children.

All regulations concerning the handling of pressure vessels must be observed. With regard to storage and transport, the following points must be taken into account:

Transport and storage of mobile cryogenic containers with volumes between 7,260 liters and 20,000 liters:

For the transport and storage of these containers, safety precautions relating to the transport of hazardous substances must be observed. Avoid transporting in vehicles where the cargo space is not separated from the driver's compartment.

Ensure that the driver is aware of the potential risks of the load and knows what to do in case of an accident or emergency.

Storage of mobile cryogenic containers of 600 liters:

Liquid containers must be stored dry and clean in a covered area, protected from weather conditions and wind, and designated for the storage of medicinal gases.

They must also be protected from heat or ignition sources, temperatures equal to or above 50°C, and from combustible materials.

Appropriate precautions must be taken to avoid shocks, impacts, or falls.

Empty and full containers must be stored separately.

Transport of containers:

Containers must be transported using suitable equipment to protect them from the risk of impact or falling.

During transport in vehicles, containers must be securely fastened. 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 packaging. The expiry date refers to the last day of the month indicated.

6. Contents of the container and other information

Composition of NITROUS OXIDE MEDICINAL 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 contents of the container:

Nitrous Oxide contained in cryogenic containers is a liquid at cryogenic temperature.

• Large mobile cryogenic container: capacity ranges approximately between 7,260 and 20,000 litres.
• Mobile cryogenic container: 600-litre vertical, 600-litre horizontal.

Not all container sizes are marketed.

Marketing Authorisation 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.

P.I. Bañuelos. Ctra. Alcalá-Daganzo, km 3.8. C/ Haití 1, Alcalá de Henares - 28806 (Madrid), Spain.

Date of the 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.

NITROUS OXIDE MEDICINAL LINDE is reserved for exclusive hospital use.

NITROUS OXIDE MEDICINAL LINDE must be used exclusively in a mixture with Medicinal Oxygen, and 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 grease.

To prevent any incident, the following instructions must be strictly observed:

• Check the equipment is in good condition before use.
• Handle the equipment with clean, grease-free hands.
• Wear clean protective goggles and gloves when handling the container.
• Do not touch cold or frosted parts.
• In case of cryogenic burn, rinse thoroughly with abundant water.
• If clothing becomes saturated with Nitrous Oxide, move away from the source of Nitrous Oxide and from areas presenting a risk of ignition, and remove the clothing immediately.
• Open the valves of cryogenic containers gradually.
• Never exceed the maximum service pressure.
• Use specific connectors for Nitrous Oxide.
• Do not use intermediate connectors that allow the connection of two incompatible devices.
• Do not subject the hose to an excessively small bending radius. Do not leave the hose on the floor.
• Provide safety devices against overpressure in Nitrous Oxide circuits where there is a risk of liquid accumulation between two valves.
• In case of leakage, close the valve with a leak-tightness defect and verify that the emergency device is activated.

IMPORTANT:

• Never introduce this liquid into a device suspected of containing combustible materials, and in particular greasy substances.

• Never clean containers containing this liquid, valves, seals, closure devices, or circuits with flammable products, and in particular greasy substances.

• Do not apply greasy substances (vaseline, ointments, etc.) to the patient's face.

• Do not use aerosol generators (hair sprays, deodorants, etc.) or solvents (alcohol, gasoline, etc.) on or near the equipment.

• Close the container valve after use.

• Do not attempt to repair a defective valve.

• Do not transfer liquid from one container to another.

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

• Never use a container showing a leak-tightness defect.

• If opening the valve results in high flow rate and frost formation, do not use the container and contact the manufacturer.

• Store empty containers with the valve closed to prevent corrosion due to moisture.

• The time-weighted average exposure limit (over 8 hours) to Nitrous Oxide is set at 25 ppm for personnel.

• Ensure systematic ventilation of the area of use, expelling 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.