Podtlenek azotu Siad

Package Leaflet: Information for the User

Nitrous Oxide SIAD, 100% Medical Liquid Gas

Dinitrogenii oxidum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Nitrous Oxide SIAD and what is it used for

The active substance is nitrous oxide (Dinitrogenii oxidum) with a 100% volume content, a medical liquid gas.
No other substances are present in the Nitrous Oxide SIAD medicine.
Nitrous Oxide SIAD is a colorless gas with a sweet odor. It is administered by inhalation.
It is supplied as a liquid gas in a gas cylinder.
Nitrous oxide has analgesic and anesthetic effects. Its effect is due to the influence on many chemical substances, so-called neurotransmitters, which act as information-conveying substances in the nervous system.
Nitrous Oxide SIAD is used:

• to induce artificial sleep (anesthetic) as an introduction to general anesthesia and, together with other intravenously or inhalationally administered anesthetics, to maintain it during a medical procedure,
• to relieve pain and for sedation (analgesic/sedative), where rapid pain relief is desired and prolonged analgesic effect is to be avoided.

Nitrous Oxide SIAD can be administered to children and adults.

2. Important information before using Nitrous Oxide SIAD

Do not use Nitrous Oxide SIAD:

• if the patient shows signs of increased intracranial pressure,
• if the patient is unconscious,
• in the case of pneumothorax,
• in diseases with expected gas accumulation in body cavities (e.g. in the intestines, nasal cavities),
• in the case of pulmonary hypertension (high blood pressure),
• in the case of vitamin B12 deficiency,
• in the case of head injuries combined with loss of consciousness,
• in the case of facial injuries,
• in the case of decompression sickness (caisson disease),
• in suffocated persons,
• during methotrexate therapy.

Warnings and precautions:

Before using Nitrous Oxide SIAD, consult a doctor:

• if the patient has a vitamin B deficiency, as nitrous oxide may increase this deficiency,
• if the patient has heart disorders or severe heart failure, nitrous oxide should be used with caution,
• nitrous oxide should not be used during laser surgery of the airways due to the risk of explosive combustion,
• nitrous oxide causes an increase in middle ear pressure
• nitrous oxide may cause loss of laryngeal reflexes and, at higher concentrations, loss of consciousness,
• the risk of hypoxia may occur after complete anesthesia. Respiratory functions and signs of intoxication will be monitored,
• if the patient currently abuses or has previously abused drugs. There is an increased risk of developing dependence on nitrous oxide, in case of its repeated use. The attending physician will decide on the possibility of treating the patient with Nitrous Oxide SIAD.

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 attending physician may order a blood test before and after treatment to assess the effects of possible vitamin B deficiency.

Nitrous Oxide SIAD and other medicines

Inform your doctor if you are taking, have recently taken, or might take any other medicines.
General anesthesia, sedatives, analgesics
Nitrous oxide, in combination with other inhalational anesthetics, enhances its effect and reduces the required dose. This also increases the effect of intravenous anesthetics, sedatives, and analgesics, thereby reducing their doses.
Local anesthesia
Nitrous oxide enhances the analgesic effect of local anesthesia used for mandibular (jawbone) anesthesia, as well as at the level of subarachnoid anesthesia.
Methotrexate
Nitrous oxide acts in the same way as methotrexate. Animal studies have shown that the chemotherapeutic effect of methotrexate increases, as does its toxicity.
Nitrous oxide acts in the same way as non-depolarizing muscle relaxants.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Nitrous oxide is not recommended during the first two trimesters of pregnancy.
Breastfeeding
Nitrous Oxide SIAD can be used in breastfeeding women.

Driving and using machines

Nitrous oxide affects mental functions.
If Nitrous Oxide SIAD is used as the only substance for pain relief and sedation, it is not recommended to drive vehicles and operate machines for at least 30 minutes after administration or until full recovery.
After anesthesia with Nitrous Oxide SIAD, driving vehicles is not recommended for 24 hours after administration.

3. How to use Nitrous Oxide SIAD

Nitrous Oxide SIAD should always be used only by inhalation, exactly as recommended by the doctor. In case of doubts, consult a doctor.
Nitrous oxide should be administered by healthcare professionals who have the necessary knowledge about the use of this medical gas.
Nitrous oxide can only be administered if equipment for clearing airways and initiating life recovery (resuscitation) is directly available.
Nitrous oxide is usually inhaled, where breathing is either independent - spontaneous - or ensured by controlled ventilation. It is always administered as a gas mixture containing at least 21% oxygen by volume to prevent hypoxia (oxygen deficiency).
Nitrous oxide can only be administered in rooms with adequate ventilation and (or) equipment to prevent excessive nitrous oxide concentration in the surrounding atmosphere, which could affect staff and other persons present near the patient being administered nitrous oxide.
Dosing

• - for pain relief and sedation (analgesia/sedation)

Nitrous oxide inhaled at concentrations up to 50% relieves pain and provides sedation without limiting consciousness and with preserved reaction to verbal communication.
At these concentrations, breathing, blood circulation, and defensive reflexes are usually safely maintained.

• - for inducing artificial sleep (anesthesia)

For anesthesia, nitrous oxide concentrations between 35% and 75% are used in combination with other anesthetics, as the effect of nitrous oxide alone is too weak to induce anesthesia.

Using more than the recommended dose of Nitrous Oxide SIAD

If too much Nitrous Oxide SIAD is administered to the patient, they will suffer from hypoxia, which means oxygen deficiency in the blood. Hypoxia must be absolutely prevented, as it can affect the body's functions and cause loss of consciousness.
If too much Nitrous Oxide SIAD is administered, administration should be stopped or the concentration of the administered substance reduced. If oxygen deficiency in the blood is suspected, it is necessary to inhale fresh air. In medical facilities, oxygen must be administered under continuous monitoring of blood oxygen levels using a pulse oximeter. Oxygen must be administered until improvement occurs and the blood is oxygenated.
The medicine will be administered to patients in medical facilities under strict supervision, so overdose is unlikely.

Safety Instructions

• Nitrous Oxide SIAD is intended for inhalation only, in accordance with the doctor's instructions.
• Always attach equipment intended only for connecting nitrous oxide.
• Like all anesthetic gases, nitrous oxide requires adequate ventilation of the rooms in which it is used.
• Nitrous oxide is a gas that supports combustion, heavier than air.
• Generally, if their work lasts longer, specialists using nitrous oxide are advised to avoid direct inhalation of air exhaled by patients.
• Gas cylinders must not be exposed to high temperatures.
• In rooms where Nitrous Oxide SIAD is used, smoking and the presence of open flames are prohibited due to the increased risk of fire.
• Never use greases, oils, or similar substances to lubricate blocked threads or when difficulties arise with fitting the administration device.
• The pressure regulator must be opened slowly and carefully.
• Handle the gas cylinder with care. Ensure it is not exposed to shocks and cannot fall.
• When administering the Nitrous Oxide SIAD product, the gas cylinder must be placed upright with the pressure regulator at the top. Nitrous oxide is drawn from the gas cylinder in the gaseous phase as a result of pressure, but it is in a liquid state inside the cylinder. If the cylinder is placed horizontally, the liquid may escape and cause damage. The pressure regulator must be opened slowly and carefully to prevent the release of liquid nitrous oxide.
• The gas cylinder must be kept clean and dry.
• The gas cylinder must be stored and transported with the valve closed and protected with a protective cap.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, or if you notice any side effects not listed in this leaflet, please tell your doctor.
The following side effects have been most commonly observed:
Common(may affect up to 1 in 10 people):

• Gastrointestinal disorders:
• nausea and vomiting. Psychiatric disorders:
• unusual euphoria, state of anxiety, dizziness, or fainting. Cardiovascular and lymphatic disorders:
• decreased oxygen saturation of red blood cells in children. Uncommon(may affect up to 1 in 100 people): Gastrointestinal disorders:
• gastric distension. Ear and labyrinth disorders:
• feeling of pressure in the middle ear. Rare(may affect up to 1 in 1000 people): Cardiac disorders:
• arrhythmias, pulmonary hypertension, hypotension in newborns. Blood and lymphatic system disorders:
• in the case of administration for more than 24 hours, - decreased red blood cell count, caused by vitamin B deficiency and (or) folic acid deficiency, decreased white blood cell count in the blood. Nervous system disorders:
• non-inflammatory disease of the spinal cord, non-inflammatory disease of the peripheral nerves, increased intracranial pressure (pressure in the skull), muscle spasms, headache. Respiratory, thoracic, and mediastinal disorders:
• temporary cessation of breathing, bronchospasm. Frequency not known(frequency cannot be estimated from the available data)Nervous system disorders:
• generalized seizures,
• effect on nerve function, feeling of numbness and weakness, usually in the legs. Psychiatric disorders:
• dependence .

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49 21 30, 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 Nitrous Oxide SIAD

Keep this medicine out of the sight and reach of children.
Gas cylinders should be stored in well-ventilated rooms intended for storing medical gases.
Gas cylinders should be stored under a roof, protected from atmospheric factors and wind, kept dry and clean, away from flammable substances.
Recommended temperatures for long-term storage are -20 to +40°C.
Measures should be taken to protect against shocks and falls.
Gas cylinders containing different types of gas should be stored separately. Full and empty cylinders should be stored separately.
Gas cylinder transport
Gas cylinders must be transported using suitable protective materials to protect them from hazardous impacts and falls, as well as to keep them in a vertical position.

6. Contents of the pack and other information

Packaging

Note: The outlet valve screw has a G3/8'' thread

Color coding

The cylindrical part of the cylinder is white with a blue circular top of the cylinder.
Not all pack sizes may be marketed.

Marketing authorization holder

SIAD Czech spol. s r.o.
K Hájům 2606/2b
Praha 5, 155 00
Czech Republic
Tel.: +420 235 097 520
Fax: +420 235 097 525

Manufacturer

SIAD Czech spol. s r.o.
U Sýpky 417
Rajhradice
664 61
Czech Republic

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

In the place of use, the lowest possible concentration of nitrous oxide permitted by local regulations should be maintained.
At present, it is not possible to establish a clear causal relationship between exposure to low concentrations of nitrous oxide and health risks for medical staff. It cannot be entirely ruled out that prolonged exposure to low concentrations of nitrous oxide in poorly ventilated rooms may be associated with an increased incidence of cancer, certain chronic diseases, and reduced fertility. More information can be found in the Summary of Product Characteristics.
Operating rooms where nitrous oxide is frequently used must be equipped with ventilation or a system for removing excess gas, which allows maintaining the nitrous oxide concentration in the environment below national limits.
Nitrous oxide can only be administered when it is possible to connect it with oxygen and in the presence of staff trained to provide first aid.
Repeated administration or exposure to nitrous oxide may lead to dependence. Caution should be exercised in the case of medical staff with occupational exposure to nitrous oxide.

Special precautions for storage

Recommended temperatures for long-term storage are -20 to +40°C.
Gas cylinders should be stored in well-ventilated rooms intended for storing medical gases.
Gas cylinders should be stored under a roof, protected from atmospheric factors and wind, kept dry and clean, away from flammable substances.
Measures should be taken to protect against shocks and falls.
Gas cylinders containing different types of gas should be stored separately. Full and empty cylinders should be stored separately.

Instructions for use/handling of Nitrous Oxide SIAD

Never use greases, oils, or similar substances to lubricate blocked threads or when difficulties arise with fitting the administration device. Touch valves and associated devices with clean and degreased hands (e.g., do not use hand cream).

Preparation for use

Use only devices intended for medical nitrous oxide.
Ensure the connecting part is clean and the gasket or "O-ring", if installed, is in good condition.
Do not open the valve abruptly.
Check the tightness according to the regulator's instructions. Do not attempt to remove a leak from the valve or device in any way other than by replacing the gasket or "O-ring" with a new one.
In case of a leak, close the valve and remove the regulator.

Using the cylinder

In the place where nitrous oxide therapy is used, smoking and the use of open flames are prohibited.
Medical gases can only be used for medical purposes.
Cylinders should be secured during storage (e.g., with a chain) to prevent falls.
To avoid contamination, do not completely empty the cylinder. A residual pressure of 3-5 bar should be maintained in the cylinder.

Disposal instructions

Do not dispose of empty cylinders. Empty gas cylinders will be collected by the supplier.