NITROGEN OXIDE MEDICAL NIPPON GASES, 98.0%, MEDICINAL LIQUEFIED GAS IN GAS CYLINDER

Introduction

Package Leaflet: Information for the User

Medicinal Nitrous Oxide Nippon Gases, 98%,liquid medicinal gas in gas cylinder

Nitrous Oxide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Medicinal Nitrous Oxide Nippon Gases and what is it used for
2. What you need to know before you start using Medicinal Nitrous Oxide Nippon Gases
3. How to use Medicinal Nitrous Oxide Nippon Gases
4. Possible side effects
5. Storage of Medicinal Nitrous Oxide Nippon Gases
6. Package contents and further information

1. What is Medicinal Nitrous Oxide Nippon Gases and what is it used for

Medicinal Nitrous Oxide Nippon Gases belongs to a group of medicines called general anesthetics.

This medicine is indicated as:

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

Adjuvant to analgesia in surgical or delivery room procedures.

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

Do not use Medicinal Nitrous Oxide Nippon Gases

If you need ventilation with pure oxygen

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

If you have an undrained air embolism, especially intracranial or pneumothorax (air in the pleural cavity), or bullous emphysema (bronchial obstruction).

It should not be administered for more than 24 hours

Warnings and precautions:

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

Caution is recommended in patients with heart failure and in patients who have undergone ear or sinus surgery.

Other medicinesandMedicinal Nitrous Oxide Nippon Gases:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicinal nitrous oxide enhances the hypnotic effects of intravenous or inhaled anesthetics (thiopental, benzodiazepines, morphinics, halogenated).

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines:

It is recommended not to drive vehicles and not to use machinery for 24 hours after anesthesia in which medicinal nitrous oxide has been used.

3. How to use Medicinal Nitrous Oxide Nippon Gases

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of medicinal nitrous oxide and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

If you think the effect of Medicinal Nitrous Oxide Nippon Gases is too strong or too weak, tell your doctor.

If you use moreMedicinal Nitrous Oxide Nippon Gasesthan you should:

In case of overdose, there is a risk of cyanosis and hypoxia. The administration of medicinal nitrous oxide should be interrupted, and the patient should be ventilated (air or oxygen).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, in administration periods exceeding 24 hours.

-Euphoric effects

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 regarding the installation and handling of pressure vessels must be followed.

• Store the cylinder in a well-ventilated area.
• Keep away from combustible materials.
• Separate cylinders during storage from flammable gases or other combustible materials.
• Keep away from ignition sources, including static discharge.
• Keep cylinders below 50°C.
• Always keep the cylinder in a vertical position.

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

Storage of gas cylinders

The premises must be protected from the weather, clean, and reserved for medical storage use.

Storage of gas cylinders in the user service and at home:

The gas cylinder must be installed in a location that allows it to be protected from the risks of bumps and falls (such as a support with fixation elements), heat sources or ignition, temperatures equal to or greater than 50°C, combustible materials, and weather conditions.

Excessive storage should be avoided.

Transportation of gas cylinders:

Gas cylinders must be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of bumps or falls. Special attention should be paid to securing the pressure reducer to avoid accidental rupture risks.

During transportation in vehicles, gas cylinders must be securely grouped. Permanent ventilation of the vehicle is mandatory, and smoking should be strictly prohibited.

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

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

6. Package contents and further information

Composition ofMedicinal Nitrous Oxide Nippon Gases

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

It does not contain excipients.

Appearance of the product and package contents

Gas cylinders:

The gas cylinders are seamless steel of various sizes. The gas cylinders are identified by the colors defined by the specific legislation for the product, which, as of this revision, are a white body and blue tip.

Sizes:

The different sizes are classified by their approximate geometric capacity in liters and the content in kg of product and m3 of gas that they provide at a pressure of 1 bar at 15°C:

1L gas cylinders containing 0.75 kg and providing 0.40 m3 of gas

2L gas cylinders containing 1.50 kg and providing 0.80 m3 of gas

3L gas cylinders containing 2.25 kg and providing 1.20 m3 of gas

3.4L gas cylinders containing 2.55 kg and providing 1.35 m3 of gas

5L gas cylinders containing 3.75 kg and providing 2.00 m3 of gas

7L gas cylinders containing 5.25 kg and providing 2.80 m3 of gas

10L gas cylinders containing 7.50 kg and providing 4.00 m3 of gas

13L gas cylinders containing 9.75 kg and providing 5.20 m3 of gas

20L gas cylinders containing 15.0 kg and providing 8.00 m3 of gas

30L gas cylinders containing 22.50 kg and providing 11.90 m3 of gas

40L gas cylinders containing 30.0 kg and providing 16.00 m3 of gas

50L gas cylinders containing 37.50 kg and providing 20.00 m3 of gas

Marketing authorization holder and manufacturer

Marketing authorization holder:

NIPPON GASES ESPAÑA S.L.U.

C/Orense, 11

28020 Madrid.

Spain

Manufacturer:

NIPPON GASES ESPAÑA S.L.U.

Calle Embajadores 474, Villaverde

28053 Madrid

Spain

Date of last revision of this leaflet:05/2019

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

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This information is intended only for healthcare professionals.

• Do not smoke when handling the product or light a fire.
• Do not use grease or oils.
• Do not drag or roll in a horizontal position. If the package is not small, use suitable carts or roll in a nearly vertical position on its base.
• Prevent water from entering the container.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Open the valves slowly and close them when the product is not in use.
• The user is prohibited from passing gas from one cylinder to another.
• In liquid or cold gas form, handle with suitable materials to avoid frostbite if it comes into contact with the skin.

Medicinal nitrous oxide gas cylinders are exclusively reserved for therapeutic use.

• Before use, verify the good condition of the material (container, delivery seal, valve, couplings, gas administration accessories, etc.) and check if the content has not exceeded its expiry date. In case of anomalies, call the distribution center for replacement with another container, indicating the detected anomaly.
• Keep the gas cylinder in a vertical position (since, being a liquid gas, a safety device for overpressure is placed in the valve that must be in the gas phase of the cylinder) and conveniently secured to prevent accidental falls.
• If the gas cylinder is to be connected to a regulation and control installation of a piped network, unseal it, connect the connection hose without forcing the connection, and follow the handling and safety instructions of the regulation and control installation.
• Medicinal nitrous oxide is a liquid gas that, as such, maintains a pressure balance between gas and liquid phases, so its content is known by the weight of the product. When the liquid phase is finished and only gas remains, the consumption of the same translates into a decrease in pressure, which will decrease very rapidly depending on the volume of the container, so when the pressure starts to decrease, it is usually indicative that there is almost no content left in the container and another container should be replaced in a very short time.
• If the gas cylinder is connected to a pressure regulator, unseal it, check that the regulator is suitable for use with medicinal nitrous oxide, connect the regulator to the valve without forcing the connections. (Note: The pressure regulator must admit a pressure of at least 1.5 times the maximum service pressure, and the low-pressure regulated part must be within the prescribed range of use). Check that the use valves and the low-pressure side pressure regulation knob are closed.
• If you want to open it, position yourself to the side of the regulator. Verify that the gas cylinder has pressure by slowly and gradually opening the valve, checking the reading on the high-pressure side of the regulator, checking for the non-existence of leaks.
• After the regulator, the accessory elements defined for its administration (oxygen mixer equipment, etc.) are connected, and according to the prescribed conditions.
• Gradually open the pressure in the low-pressure regulated side knob until the desired pressure is obtained, and then gradually open the consumption passage valves (flowmeters, shut-off valves, etc.)
• Do not keep the gas cylinder valve open if it is not being used.

Once the content is finished (not less than 10 bar), close the consumption valve, close the gas cylinder valve, disconnect the pressure regulator, remove the chain or fixation element, and remove it to the empty container area, calling the distribution center for replacement with another full container or return of the same.