Nitrous oxide medicinal Nippon Gases, 98.0%, medicinal liquefied gas in gas cylinder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nitrous Oxide Medicinal Nippon Gases, 98%, medicinal liquefied gas in gas cartridge

Nitrous Oxide

Read the entire 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nitrous Oxide Medicinal Nippon Gases is and what it is used for
2. What you need to know before using Nitrous Oxide Medicinal Nippon Gases
3. How to use Nitrous Oxide Medicinal Nippon Gases
4. Possible adverse effects
5. How to store Nitrous Oxide Medicinal Nippon Gases
6. Contents of the pack and other information

1. What Protóxido de Nitrógeno Medicinal Nippon Gases is and what it is used for

Protóxido de Nitrógeno Medicinal Nippon Gases belongs to a group of medicines called general anesthetics.

This medicine is indicated as:

• An adjunct to general anesthesia, in combination with all anesthetic agents administered intravenously or by inhalation.

An analgesic adjunct in the operating room or in the delivery room.

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

Do not use Nitrous Oxide Medicinal Nippon Gases

If you require ventilation with pure oxygen

In patients with intraocular gas injection (e.g.: SF6, C3F8, C2F6)

If you have untreated air embolism, especially intracranial or pneumothorax (air in pleural cavity), vesicular emphysema (bronchial obstruction)

Must not be administered for longer than 24 hours

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Nitrous Oxide Medicinal Nippon Gases

Caution is recommended in patients with cardiac insufficiency and in patients who have undergone sinus or inner ear surgery.

Other medicines and Nitrous Oxide Medicinal Nippon Gases:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Medicinal nitrous oxide potentiates the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphine derivatives, halogenated agents).

The combined use of medicinal nitrous oxide and methotrexate increases the adverse effects of this cytotoxic drug.

Pregnancy, breastfeeding and fertility:

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

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

Driving and using machines:

It is recommended not to drive or operate machinery within 24 hours following anesthesia in which medicinal nitrous oxide has been used.

3. How to use Nitrous Oxide Medicinal Nippon Gases

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If you feel that the effect of Nitrous Oxide Medicinal Nippon Gases is too strong or too weak, inform your doctor.

If you use more Nitrous Oxide Medicinal Nippon Gases than you should:

In case of overdose, there is a risk of cyanosis and hypoxia. Administration of medicinal nitrous oxide must be stopped, and the patient must be ventilated (with air or oxygen).

If you are concerned that you have received too much Nitrous Oxide, speak to your doctor or another healthcare professional immediately.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Tell your doctor as soon as possible if you experience any of the following symptoms:

-Nausea and vomiting

-Increased pressure and/or volume of the body's air cavities

-Severe hematological disorders: megaloblastic anemia, leukopenia, agranulocytosis, occurring during administration periods exceeding 24 hours.

-Euphoric effects

-Effects on the central nervous system: myeloneuropathies, neuropathies, and other neurological adverse reactions due to vitamin B12 deficiency, generalized seizures with unknown frequency.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Nitrous Oxide Nippon Gases

Keep this medicine out of the sight and reach of children.

All regulations relating to the installation and handling of pressure vessels must be observed.

• Store the container in a well-ventilated place.
• Keep away from combustible materials.
• Separate containers during storage from flammable gases or other combustible materials.
• Keep away from sources of ignition, including static discharge.
• Keep containers below 50°C.
• Always keep the container in an upright position.

In addition to the above precautions, the following must also be taken into account:

Storage of gas cartridges

Storage areas must be protected from adverse weather conditions, clean, and designated exclusively for medical use storage.

Storage of gas cartridges at user facilities and in domestic settings:

The gas cartridge must be installed in a location that protects it from risks of impact and falling (e.g., using a stand with securing elements), from heat sources or ignition sources, from temperatures equal to or above 50°C, from combustible materials, and from adverse weather conditions.

Excessive storage must be avoided.

Transport of gas cartridges:

Gas cartridges must be transported using appropriate equipment (e.g., a trolley equipped with chains, barriers, or rings) to protect them from risks of impact or falling. Special attention must be paid to securing the pressure regulator to prevent accidental breakage.

During transport in vehicles, gas cartridges must be securely grouped together. Permanent ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Medicinal Nitrous Oxide Nippon Gases

The active substance is medicinal nitrous oxide, and its concentration is greater than 98% by volume.

It contains no excipients.

Appearance of the product and contents of the container

Gas cylinders:

Gas cylinders are seamless steel containers of various sizes. The cylinders are identified by the colors defined by specific legislation for this product; at the time of this revision, these are a white body with a blue shoulder.

Sizes:

The following table lists the different sizes classified by their approximate geometric capacity in liters, and the content in kg of product and m³ of gas provided at a pressure of 1 bar and 15°C:

• 1L gas cylinder containing 0.75 kg, providing 0.40 m³ of gas
• 2L gas cylinder containing 1.50 kg, providing 0.80 m³ of gas
• 3L gas cylinder containing 2.25 kg, providing 1.20 m³ of gas
• 3.4L gas cylinder containing 2.55 kg, providing 1.35 m³ of gas
• 5L gas cylinder containing 3.75 kg, providing 2.00 m³ of gas
• 7L gas cylinder containing 5.25 kg, providing 2.80 m³ of gas
• 10L gas cylinder containing 7.50 kg, providing 4.00 m³ of gas
• 13L gas cylinder containing 9.75 kg, providing 5.20 m³ of gas
• 20L gas cylinder containing 15.0 kg, providing 8.00 m³ of gas
• 30L gas cylinder containing 22.50 kg, providing 11.90 m³ of gas
• 40L gas cylinder containing 30.0 kg, providing 16.00 m³ of gas
• 50L gas cylinder containing 37.50 kg, providing 20.00 m³ of gas

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

NIPPON SANSO ESPAÑA S.L.U.
C/Orense, 11
28020 Madrid
Spain

Manufacturer:

NIPPON SANSO ESPAÑA S.L.U.
Calle Embajadores 474, Villaverde
28053 Madrid
Spain

Date of latest revision of this leaflet: 05/2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended exclusively for healthcare professionals.

• Do not smoke when handling the product or light any flame.
• Do not use fats or oils.
• Do not drag or roll the cylinder horizontally. If the container is not small, use appropriate trolleys or roll it in an almost vertical position on its base.
• Prevent water from entering the container.
• Use only equipment specifically approved for this product and suitable for the intended pressure and temperature conditions.
• Open valves slowly and close them when the product is not in use.
• Transferring gas from one cylinder to another is strictly prohibited for the user.
• When in liquid form or as cold gas, handle with appropriate materials to prevent frostbite if it comes into contact with the skin.

Nitrous oxide medicinal gas cylinders are reserved exclusively for therapeutic use.

• Before use, check that all equipment is in good condition (container, delivery seal, valve, couplings, gas administration accessories, etc.) and verify that the contents have not expired. In case of any anomalies, contact the distribution center to replace the container, indicating the detected issue.
• Keep the gas cylinder in an upright position (since it is a liquefied gas, the overpressure safety device located in the valve must remain in the gas phase of the cylinder) and securely fastened to prevent accidental falling.
• If the gas cylinder is to be connected to a pressure regulation and control system of a piped network, break the seal, connect the hose without forcing the coupling, and follow the handling and safety instructions of the regulation and control system.
• Nitrous oxide is a liquefied gas that maintains an equilibrium of pressure between the gas and liquid phases. Therefore, the content is measured by the weight of the product. When the liquid phase is depleted and only gas remains, consumption leads to a rapid drop in pressure, depending on the container volume. Thus, a drop in pressure usually indicates that the cylinder is nearly empty and should be replaced promptly.
• If connecting the gas cylinder to a pressure regulator, break the seal, verify that the regulator is suitable for use with medicinal nitrous oxide, and connect the regulator to the valve without forcing the connections. (Note: The pressure regulator must withstand a pressure of at least 1.5 times the maximum service pressure; the regulated low-pressure side must match the prescribed operating range.) Ensure that the usage valves and the pressure adjustment knob on the low-pressure side are closed.
• When opening, stand to one side of the regulator. Check that the gas cylinder is pressurized by slowly and gradually opening the valve, observing the reading on the high-pressure side of the regulator, and checking for leaks.
• After the regulator, connect the defined accessories for administration (e.g., oxygen mixing device, etc.) according to prescribed conditions.
• Gradually open the adjustment knob on the regulated low-pressure side to achieve the desired pressure, then gradually open the usage flow valves (flowmeters, shut-off valves, etc.).
• Do not leave the gas cylinder valve open when not in use.

Once the contents are depleted (not below 10 bar), close the usage valve, close the gas cylinder valve, disconnect the pressure regulator, remove the securing chain or fastening device, and move the cylinder to the area designated for empty containers. Contact the distribution center to arrange for replacement with a full cylinder or return of the empty one.