Podtlenek azotu N2o

Leaflet attached to the packaging: patient information

NITROUS OXIDE, medical gas
Dinitrogenii oxidum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is the medicine and what is it used for
• 2. Important information before using the medicine
• 3. How to use the medicine
• 4. Possible side effects
• 5. How to store the medicine
• 6. Contents of the packaging and other information

1. What is the medicine and what is it used for

is a gas with analgesic and anesthetic effects. It is not metabolized in the body and is excreted unchanged in exhaled air - for use only in closed healthcare facilities.
To induce and maintain general anesthesia in combination with other anesthetics (inhalation or intravenous).
In a mixture with oxygen to achieve an analgesic effect caused by shallow anesthesia without loss of consciousness (e.g., dressing changes, diagnostic tests, obstetric analgesia).

2. Important information before using the medicine

When not to use the medicine:

• nitrous oxide should not be administered without the addition of oxygen and in a breathing mixture containing less than 30% oxygen. The administration time in a mixture with oxygen should not exceed 12 hours,
• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment, you should discuss it with your doctor.
If the patient has or has had a problem with substance abuse/psychoactive drugs, the risk of dependence on nitrous oxide is higher in the case of repeated use. The doctor will decide whether it can be used in such a case.
Caution should be exercised in the case of hypovolemia, shock, heart disease - possibility of severe hypotension.
Repeated or prolonged use of nitrous oxide may increase the risk of vitamin B deficiency, which can lead to bone marrow or nervous system damage.
The doctor may order a blood test before and after using nitrous oxide to assess the effects of possible vitamin B deficiency.

Medicine interactions

Used together with medicines that have a depressive effect on the central nervous system, respiratory system, or cause hypotension, may enhance their effect. Used in combination with high doses of Fentanyl (and its derivatives) may cause a decrease in heart rate and cardiac output. These symptoms may occur especially in patients with left ventricular heart failure.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Animal studies have shown a potential risk of fetal death, growth disorders, and bone development disorders after prolonged use of nitrous oxide.

Driving and using machines

Impairs the ability to drive vehicles or operate machinery.

3. How to use the medicine

Only as directed by a doctor. Nitrous oxide is administered in a mixture with oxygen and possibly with other inhalation or intravenous anesthetics, using special calibrated inhalation devices or anesthesia equipment. It is usually dosed through a flow meter with measurement in liters per minute. It is usually used in a mixture with oxygen in a volume ratio of 70% nitrous oxide and 30% oxygen for maintaining anesthesia or in a ratio of 50% nitrous oxide and 50% oxygen to induce short-term analgesia.

Stopping the medicine

The only symptom may be signs of hypoxia when nitrous oxide administration is stopped and atmospheric air breathing is started. Due to the sudden cessation of nitrous oxide inhalation, there is a release of nitrous oxide from tissues, an increase in its volume in lung alveoli, which leads to a dilution of oxygen in the air. As a precaution, the nitrous oxide supply should be turned off in advance and the patient should be ventilated with pure oxygen to remove nitrous oxide from the tissues.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nitrous oxide used in general anesthesia does not cause any side effects. After surgical procedures, nausea and vomiting may occur. During prolonged use, leukopenia or thrombocytopenia and megaloblastic anemia (especially in cases of vitamin B deficiency) may occur, which disappear after returning to breathing air. Due to easy penetration into closed spaces, it may increase their volume or pressure (middle ear, paranasal sinuses, inflated intestinal loops, pneumothorax).
Generalized seizures of unknown frequency.
Of unknown frequency (frequency cannot be determined based on available data)

• Dependence
• Symptoms from the nervous system, feeling of numbness and weakness, usually in the legs.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store the medicine

The medicine should be stored out of sight and out of reach of children.
In accordance with the regulations on pressure vessels, nitrous oxide must be stored only in original cylinders filled by the manufacturer and approved for use by the Office of Technical Inspection (UDT).
Using cylinders not in accordance with their intended use and filling them by the user or third parties is prohibited. When receiving cylinders containing nitrous oxide, check if the heat-shrinkable film protecting the valve is intact. In case of damage to the film, refuse to accept it. Before use, the cylinder must be stored at a temperature of 20°C for at least 6 hours. The nitrous oxide cylinder should be stored in a vertical position and secured against tipping over and direct sunlight or other heat sources. Protect the valves and reducers from contamination with fats or oils. Before screwing on the threaded connector, briefly open the valve to remove any dust particles. Check the sealing ring of the threaded connector.
The cylinder should be considered empty when the pressure in the cylinder at room temperature drops to 5 bar.
Do not use this medicine after the expiry date stated on the label on the cylinder.
Shelf life: 3 years

6. Contents of the packaging and other information

What the medicine contains

The cylinder contains nitrous oxide N2O - (Mol. 44.01) in a liquid state.
N2O - non-flammable, colorless gas without smell and taste, supporting combustion.
1 liter of nitrous oxide under pressure 760 mm Hg and at a temperature of 0°C weighs 1.977 g.

What the medicine looks like and what the packaging contains

A cylinder with a water capacity of 10 liters and containing 7 kg of liquid nitrous oxide (at a temperature of 15°C, the pressure in the cylinder is approximately 50 bar).
A cylinder with a water capacity of 40 liters and containing 28 kg of liquid nitrous oxide (at a temperature of 15°C, the pressure in the cylinder is approximately 50 bar).

Marketing authorization holder

Linde Gaz Polska Sp. z o. o.
ul. prof. Michała Życzkowskiego 17
31-864 Kraków

Manufacturer

Linde Gaz Polska Sp. z o. o.
Kościan Plant
ul. Przemysłowa 17
64-000 Kościan
Linde Gaz Polska Sp. z o. o.
Tarnów Plant
ul. Żwirowa 4
33-100 Tarnów
Linde Gaz Polska Sp. z o. o.
Łódź Plant
ul. Traktorowa 145
91-204 Łódź
Linde Gaz Polska Sp. z o. o.
Warsaw Plant
ul. Kasprowicza 132
01-949 Warszawa
Linde Gaz Polska Sp. z o. o.
ul. Zgrupowania AK “Kampinos” 30
01-943 Warszawa
Linde Gaz Polska Sp. z o. o.
ul. prof. Michała Życzkowskiego 17
31-864 Kraków
Linde Gaz Polska Sp. z o. o.
Biskupice Podgórne Plant
ul. LG 2, Biskupice Podgórne
55-040 Kobierzyce

Date of last update of the leaflet:

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Information intended only for medical professionals:
Repeated administration or exposure to nitrous oxide may lead to dependence.
Caution should be exercised in the case of medical personnel professionally exposed to nitrous oxide.