Nitrous oxide medicinal liquid Linde, 98%, medicinal cryogenic gas in fixed 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 fixed 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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 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 to expand, and gases trapped 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 who have undergone 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, or presence of 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 gaseous distension.
• If you have severe heart failure (e.g., after cardiac surgery), as nitrous oxide may worsen cardiac function.
  • If you have persistent signs of confusion, impaired cognitive function, or other symptoms that could be related to increased intracranial pressure, as 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 impair protective reflexes.
  • If you have diagnosed, 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 may 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 may increase middle ear pressure.

• If you have a history of medication/drug abuse, because there is a high risk of developing dependence on nitrous oxide if taken repeatedly.

Your doctor will decide whether Nitrous Oxide Medicinal Liquid Linde is suitable for you.

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

Use of Nitrous Oxide Medicinal Linde with other medicines

Nitrous Oxide Medicinal Liquid Linde enhances the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, opioids, halogenated agents), so the dosage of these 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 side effects.

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

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

• Obstetric analgesia:

The use of Nitrous Oxide Medicinal Liquid 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 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 doctor 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, you and the administration of this medicine must be monitored to ensure that nitrous oxide is administered safely. After administration is completed, 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 volume of inhaled gas.

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

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

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

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

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

Very rare adverse reactions (affecting 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), 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.
• Fixed cryogenic containers must be installed in clean, well-ventilated areas, free from flammable materials.
• Storage of gases intended for medical use must be separated from gases intended for other purposes.
• Fixed cryogenic containers must be protected from sources of ignition, heat, combustible materials, and even static discharges.
• Fixed cryogenic containers must be protected from risks of impact, shocks, or falls.
• No parking must be allowed in the area where fixed cryogenic containers are located.

Expiry:

Do not use MEDICINAL NITROUS OXIDE LINDE after the expiry date:

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

6. Contents of the container and additional information

Composition of NITROUS OXIDE MEDICINAL LINDE:

• The active substance is: Nitrous Oxide (N2O) at a concentration greater than 98.0% (v/v).
• Does not contain excipients.

Appearance of the product and contents of the container:

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

Not all pack 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.

Date of the most recent revision of this package leaflet: January 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.es

This information is intended for healthcare professionals only

LINDE MEDICINAL NITROUS OXIDE is reserved for exclusive hospital use.

LINDE MEDICINAL NITROUS OXIDE must only be used in 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 must exercise caution regarding occupational exposure to nitrous oxide.

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

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

• Check that equipment is in good condition before use.
• Handle equipment with clean, grease-free hands.
• Wear protective goggles and clean 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 nitrous oxide source and from areas presenting a risk of ignition, and remove the clothing immediately.
• Open valves of cryogenic containers gradually.
• Never exceed the maximum service pressure.
• Use specific connectors for nitrous oxide.
• Do not use adapters that allow connection of two devices that are not compatible.
• Do not bend the hose to an excessively small radius. Do not leave the hose on the floor.
• Install overpressure protection devices in nitrous oxide circuits where there is a risk of liquid accumulation between two valves.
• In case of leakage, close the valve with a leakage defect and verify that the emergency device activates.

IMPORTANT:

• Never introduce this liquid into any apparatus that might contain flammable substances, particularly greasy substances.

• Never clean containers containing this liquid, valves, seals, 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 sprays, deodorants, etc.) or solvent generators (alcohol, gasoline, etc.) on the equipment or in its vicinity.

• 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 leakage defect.

• Never use a container that shows any leakage defect.

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

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.