Nitrogen suboxide siad

Package leaflet: Information for the user

Nitrous oxide SIAD, 100% medicinal liquid gas
Dinitrogenii oxidum
Please read all of this leaflet carefully before 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.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Nitrous oxide SIAD is and what it is used for
2. What you need to know before you use 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 Nitrous oxide SIAD is and what it is used for

The active substance is nitrous oxide (Dinitrogenii oxidum), 100% by volume, medicinal liquid gas.
No other substances are present in Nitrous oxide SIAD.
Nitrous oxide SIAD is a colourless gas with a slightly sweet odour. It is administered by inhalation.
It is supplied as a liquefied gas in a gas cylinder.
Nitrous oxide relieves pain (analgesic effect) and has anaesthetic properties.
The effect of nitrous oxide results from its influence on various chemical substances, known as neurotransmitters, which act as messengers in the nervous system.

Nitrous oxide SIAD is used:

• To induce artificial sleep (as an anaesthetic agent), either as an induction agent for general anaesthesia or in combination with other intravenous or inhaled anaesthetic agents to maintain anaesthesia during a medical procedure.
• For pain relief and sedation (analgesic/sedative agent), where rapid pain relief is desired and prolonged analgesic action is to be avoided.

Nitrous oxide SIAD may be administered to both children and adults.

2. Important information before using Nitrous Oxide SIAD

Do not use Nitrous Oxide SIAD:

• if the patient shows symptoms of increased intracranial pressure,
• if the patient is unconscious,
• in the case of pneumothorax,
• in diseases with anticipated accumulation of gases in body cavities (e.g. in intestines, nasal cavities),
• in pulmonary hypertension (elevated pressure),
• in vitamin B12 deficiency,
• in head injuries combined with loss of consciousness,
• in facial trauma,
• in decompression sickness (decompression illness),
• in depressed patients,
• during methotrexate therapy.

Warnings and precautions:
Before using Nitrous Oxide SIAD, consult a physician:

• if the patient suffers from vitamin B12 deficiency, as nitrous oxide may exacerbate this deficiency,
• if the patient has heart disorders or severe heart failure, nitrous oxide should be used with caution,
• nitrous oxide must not be used during laser surgery of the airways due to the risk of explosive combustion,
• nitrous oxide causes increased pressure in the middle ear,
• nitrous oxide may cause loss of laryngeal reflexes, and at higher concentrations, loss of consciousness,
• risk of hypoxia may occur following general anaesthesia. Respiratory function and signs of sedation will be monitored,
• if the patient is currently misusing drugs or has a history of drug abuse. There is an increased risk of developing dependence on nitrous oxide with repeated use. The treating physician will decide whether treatment with Nitrous Oxide SIAD is appropriate for the patient.

Repeated or prolonged use of nitrous oxide may increase the risk of vitamin B12 deficiency, which in turn may lead to bone marrow or nervous system damage. The treating physician may order blood tests before and after treatment to assess the potential effects of vitamin B12 deficiency.

Nitrous Oxide SIAD and other medicines
You should inform your doctor if you are currently taking, have recently taken, or might possibly take any other medicines.

General anaesthetics, sedatives, analgesics
Nitrous oxide, when combined with other inhaled anaesthetics, enhances their effect and reduces the required dosage. It also increases the effect of intravenous anaesthetics, sedatives, and analgesics, thereby allowing for reduction in their doses.

Local anaesthesia
N₂O enhances the analgesic effect of local anaesthesia used for mandibular (jawbone) anaesthesia, as well as in subarachnoid anaesthesia.

Methotrexate
N₂O acts similarly to methotrexate. Animal studies have shown that the chemotherapeutic effect of methotrexate, as well as its toxicity, increases.

N₂O acts similarly to non-depolarizing muscle relaxants (muscle relaxants).

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of nitrous oxide is not recommended during the first two trimesters of pregnancy.

Breastfeeding
Nitrous Oxide SIAD may be used in women who are breastfeeding.

Driving and operating machinery
Nitrous oxide affects mental functions.
If Nitrous Oxide SIAD is used as the sole analgesic and sedative agent, driving and operating machinery should not be undertaken for at least 30 minutes after administration, or until full recovery to normal state.
After anaesthesia with Nitrous Oxide SIAD, driving is not recommended for 24 hours following administration.

3. How to use Nitrous oxide SIAD

Nitrous oxide SIAD must always be administered by inhalation only, strictly in accordance with
the physician's instructions. In case of doubt, consult a physician.
Nitrous oxide should be administered only by healthcare personnel who have appropriate knowledge regarding the use of this medical gas.
Nitrous oxide may be administered only if equipment for airway clearance and initiation of life support (resuscitation) is immediately available.
Nitrous oxide is usually inhaled, with respiration being either spontaneous (independent) or supported by controlled ventilation. It is always administered as a gas mixture containing at least 21% oxygen by volume to prevent oxygen deficiency (so-called "hypoxia").
Nitrous oxide must be administered only in rooms with adequate ventilation and/or equipped with systems preventing excessive accumulation of nitrous oxide in the surrounding atmosphere, which could affect healthcare workers and other individuals near the patient receiving nitrous oxide.

Dosage

• For analgesic and sedative purposes (pain relief / sedation)

Inhaled nitrous oxide at concentrations up to 50% relieves pain and produces calming effects without impairing consciousness and while maintaining responsiveness to verbal communication.
At these concentrations, breathing, circulation, and protective reflexes are usually preserved safely.

• For induction of artificial sleep (anaesthesia)

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

Administration of a higher than recommended dose of Nitrous oxide SIAD
If too much Nitrous oxide SIAD is administered to a patient, hypoxia (oxygen deficiency in the blood) may occur. Hypoxia must be strictly avoided, as it may affect bodily functions and lead to loss of consciousness.
If an excessive amount of Nitrous oxide SIAD has been administered, administration must be stopped or the concentration reduced. If oxygen deficiency in the blood is suspected, fresh air must be inhaled immediately. In medical facilities, oxygen must be administered under continuous monitoring of blood oxygen levels using a pulse oximeter. Oxygen should be administered until improvement occurs and blood oxygen saturation is restored.
The drug will be administered to patients in medical facilities under strict supervision; therefore, overdose is unlikely.

Safety instructions

• Nitrous oxide SIAD is intended exclusively for inhalation use, as directed by a physician.
• Always use equipment specifically designed for nitrous oxide connection only.
• Like all anaesthetic gases, nitrous oxide requires adequate room ventilation where it is administered.
• Nitrous oxide is a combustion-supporting gas and is heavier than air.
• Healthcare professionals administering nitrous oxide should generally avoid inhaling exhaled air from patients directly, especially during prolonged procedures.
• Gas cylinders must not be exposed to excessively high temperatures.
• Smoking and open flames are strictly prohibited in rooms where Nitrous oxide SIAD is used due to increased fire risk.
• Never use oils, greases, or similar substances to lubricate blocked threads.
• Open the pressure regulator slowly and carefully.
• Handle the gas cylinder with care. Ensure it is protected from shocks and cannot fall over.
• When administering Nitrous oxide SIAD, the gas cylinder must be kept in an upright position with the pressure regulator on top. Nitrous oxide is withdrawn from the cylinder in gaseous phase due to pressure, although it is stored in liquid form inside the cylinder. If the cylinder is placed horizontally, liquid may escape and cause damage. The pressure regulator must be opened slowly and carefully to prevent release of liquid nitrous oxide.
• Keep the gas cylinder clean and dry.
• Store and transport the gas cylinder with the valve closed and protected by the safety cap.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reaction becomes serious, or if you notice any adverse reactions not listed in this leaflet, please inform your doctor.
The following adverse reactions have been most commonly observed:
Common (may affect up to 1 in 10 patients):
Gastrointestinal disorders:

• nausea and vomiting.
  Psychiatric disorders:
• unnaturally elevated mood, anxiety, dizziness or fainting.
  Disorders of the blood and lymphatic system:
• reduced oxygen saturation of haemoglobin in children.
  Uncommon (may affect up to 1 in 100 patients):
  Gastrointestinal disorders:
• abdominal distension.
  Ear and labyrinth disorders:
• sensation of pressure in the middle ear.
  Rare (may affect up to 1 in 1000 patients):
  Cardiac disorders:
• heart rhythm disorders, pulmonary hypertension, arterial hypotension in newborns.
  Blood and lymphatic system disorders:
• when administered for longer than 24 hours – reduced number of red blood cells caused by deficiency of vitamin B_(12) and (or) folic acid, reduced number of white blood cells in blood.
  Nervous system disorders:
• non-inflammatory spinal cord disease, non-inflammatory polyneuropathy, increased intracranial pressure (pressure within the skull), muscle spasms, headache.
  Respiratory, thoracic and mediastinal disorders:
• transient cessation of breathing, bronchoconstriction.
  Frequency not known (frequency cannot be estimated from the available data):
  Nervous system disorders:
• generalized seizures,
• effects on nerve function, sensation of numbness and weakness, usually in the legs.
  Psychiatric disorders:
• dependence.
  Reporting of adverse reactions
  If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 Adverse reactions can also be reported to the marketing authorisation holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Nitrous oxide SIAD

Keep this medicine out of sight and reach of children.
Gas cylinders must be stored in appropriately ventilated rooms intended for storage of medical gases.
Gas cylinders must be stored under cover, protected from weather conditions and wind, and kept dry and clean, away from flammable materials.
Recommended temperatures for long-term storage are -20 to +40°C.
Measures must be taken to protect against shocks and falls.
Cylinders containing different types of gas must be stored separately. Full and empty cylinders must be stored separately.
Transport of gas in cylinders
Gas cylinders must be transported using appropriate protective materials to safeguard them against dangerous impacts and falls, and to keep them in an upright position.

6. Contents of the package and other information

Packaging

Warning: the valve screw closing the outlet has a G3/8" thread
Colour marking
Cylindrical part of the cylinder white with a blue circular top of the cylinder.
Not all package sizes may be marketed.
Responsible person
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

Information intended exclusively for medical professionals:

Maintain the lowest possible concentration of nitrous oxide at the site of use
permitted by local regulations.
Currently, a definitive causal relationship between exposure to low concentrations of nitrous oxide and health risks for medical personnel cannot be established. However, it cannot be completely ruled out that chronic exposure to low concentrations of nitrous oxide in poorly ventilated areas may be associated with an increased incidence of neoplastic diseases, certain chronic diseases, and reduced fertility. More information is available in the Product Information Leaflet.

Operating rooms where nitrous oxide is frequently used must be equipped with ventilation or gas scavenging systems capable of maintaining ambient nitrous oxide concentrations below national exposure limits.

Nitrous oxide may only be administered when it can be mixed with oxygen and in the presence of trained personnel qualified to provide first aid.

Repeated administration or exposure to nitrous oxide may lead to dependence. Caution should be exercised in the case of medical professionals with occupational exposure to nitrous oxide.

Special precautions for storage
Recommended long-term storage temperature is -20 to +40°C.
Gas cylinders must be stored in appropriately ventilated rooms designated for medical gas storage.
Cylinders must be stored under cover, protected from weather conditions and wind, and kept dry and clean, away from flammable substances.
Precautions must be taken to protect cylinders from shocks and falls.
Cylinders containing different types of gases must be stored separately. Full and empty cylinders must be stored separately.

Instructions for use/handling of Nitrous Oxide SIAD
Never use greases, oils, or similar substances to lubricate stuck threads or when difficulties occur in attaching the delivery device. Handle valves and associated equipment only with clean, degreased hands (e.g., do not use hand cream).

Preparation for use
Use only delivery devices intended for medical nitrous oxide.
Ensure that the connecting part is clean and that the sealing washer or "O" ring, if fitted, is in good condition.
Do not open the valve abruptly.
Check for leaks according to the regulator instructions. Do not attempt to stop a leak from the valve or device by any method other than replacing the sealing washer or "O" ring with a new one.
In case of leakage, close the valve and remove the regulator.

Cylinder use
Smoking and the use of open flames are prohibited in areas where nitrous oxide therapy is administered.
Medical gases may only be used for medical purposes.
Gas cylinders must be secured during storage (e.g., with a chain) to prevent falling.
To avoid contamination, do not completely empty cylinders. Maintain a residual pressure of 3–5 bar in the cylinder.

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