Podtlenek azotu Air Products

1. What is Nitrous Oxide AIR PRODUCTS and what is it used for

Product group

Nitrous Oxide AIR PRODUCTSis an inhalation gas and belongs to the group of other general anesthetics.

What is Nitrous Oxide AIR PRODUCTS used for?

• Nitrous Oxide AIR PRODUCTS, in a mixture with oxygen, is administered as a pain reliever with weak anesthetic properties for short, painful procedures, e.g., after an accident, with burns, dental procedures, childbirth, and otolaryngological surgery. Such a mixture always consists of 50% nitrous oxide and 50% oxygen.
• A mixture of Nitrous Oxide AIR PRODUCTS with oxygen is also used as a basic anesthetic in combination with other inhalation or intravenous anesthetics. In such cases, the composition of the mixture is different: the oxygen content in the mixture is at least 21% v/v.

2. Important information before using Nitrous Oxide AIR PRODUCTS

When not to use Nitrous Oxide AIR PRODUCTS

• If the patient regularly or constantly breathes medical oxygen.
• If air or another gas may accumulate in the body. Especially in the case of untreated pneumothorax, where gas accumulates in the pleural cavity, free gas in the abdominal cavity, pulmonary emphysema, decompression sickness.
• If the patient has consciousness disorders that prevent cooperation with the doctor.
• When there is acute intestinal obstruction.
• When there is increased blood pressure in the brain, characterized by severe headaches, loss of visual acuity, increased cerebrospinal fluid pressure, nerve paralysis symptoms, and consciousness disorders.
• When there are facial injuries in the area where the mask is to be placed.
• After injecting gas (SF, CF) into the eyeball, as there is a risk of further expansion of the gas, which may lead to vision loss.
• In the case of vitamin B deficiency in early pregnancy.

Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS

Warnings and precautions.

Before starting to use Nitrous Oxide AIR PRODUCTS, discuss it with your doctor

• if you have or have had a problem with drug abuse, there is a greater risk of dependence on nitrous oxide if you use it repeatedly. In such a case, the doctor will decide whether treatment with Nitrous Oxide AIR PRODUCTS is possible in your case.
• in case of vitamin B deficiency, pernicious anemia, Crohn's disease (recurring severe intestinal inflammation associated with diarrhea, abdominal pain, fever, and weight loss), or vegetarianism.
• in case of heart failure or other heart rhythm disorders.
• in case of significant blood pressure drop caused by shock or heart failure.
• in case of sickle cell anemia (a blood disease in which red blood cells have an abnormal shape).
• during childbirth, when it is not recommended to administer nitrous oxide with opioids (opium-containing medications), as it may lower the level of consciousness.
• after an eye injection, you should wait an appropriate amount of time to avoid the risk of vision disturbances.
• when using benzodiazepines (a group of medications with a relaxing, calming, and muscle-relaxing effect), as loss of consciousness may occur.
• when being treated with bleomycin (an anticancer medication).

Repeating or prolonged use of nitrous oxide may increase the risk of vitamin B12 deficiency, which can lead to bone marrow or nervous system damage. The doctor may decide to perform a blood test before and after treatment to assess the level of possible vitamin B12 deficiency.

Nitrous Oxide AIR PRODUCTS and other medications

Inform your doctor about all medications you are currently taking or have recently taken, including those available without a prescription.
NOTE: The following issues may also apply to medications used before administering Nitrous Oxide AIR PRODUCTS or for some time after its discontinuation.

• Intravenous or inhalation sedatives or anesthetics enhance the effect of Nitrous Oxide AIR PRODUCTS.
• Morphine derivatives (opioids) have an additive pain-relieving and calming effect compared to Nitrous Oxide AIR PRODUCTS.
• Benzodiazepines and barbiturates (a group of medications with a calming and/or muscle-relaxing effect) enhance the effect of Nitrous Oxide AIR PRODUCTS.
• Certain muscle relaxants (e.g., pancuronium, vecuronium) enhance the effect of Nitrous Oxide AIR PRODUCTS.
• Nitrous Oxide AIR PRODUCTS inactivates vitamin B12, which increases the toxicity of sodium nitroprusside (a medication for high blood pressure) and methotrexate (a medication used for rheumatism and cancer).
• Bleomycin (an anticancer medication) increases the risk of lung damage associated with increased oxygen concentration during anesthesia.

Using Nitrous Oxide AIR PRODUCTS with food and drink

If Nitrous Oxide AIR PRODUCTS is used as an anesthetic, you should avoid eating or drinking from the previous night. Nitrous Oxide AIR PRODUCTS, used alone or with other medications, may cause nausea or vomiting.
See section 4 "Possible side effects".
Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medication.
Pregnancy
Limited data on short-term use of Nitrous Oxide AIR PRODUCTS in pregnant women do not confirm an increased risk of congenital anomalies. Nitrous Oxide AIR PRODUCTS may rarely cause respiratory disorders (decreased breathing frequency) in newborns. Nitrous Oxide AIR PRODUCTS should only be used during pregnancy if absolutely necessary. Frequent or prolonged use should be avoided.
Breastfeeding
There is no data on the excretion of Nitrous Oxide AIR PRODUCTS into human milk. After short-term administration of Nitrous Oxide AIR PRODUCTS, it is not necessary to interrupt breastfeeding.

Driving and using machines

Nitrous Oxide AIR PRODUCTS significantly impairs the ability to drive vehicles and operate machinery. You should wait 24 hours after complete anesthesia with Nitrous Oxide AIR PRODUCTS in combination with another anesthetic or pain reliever.
After short-term administration of Nitrous Oxide AIR PRODUCTS for pain relief, you should be under observation until all side effects have subsided and full consciousness has been regained before using Nitrous Oxide AIR PRODUCTS.

3. How to use Nitrous Oxide AIR PRODUCTS

Nitrous Oxide AIR PRODUCTS should always be used according to the doctor's instructions. In case of doubts, consult a doctor.
Dosing will be determined by the doctor.
Short-term use for pain relief
Nitrous Oxide AIR PRODUCTS is administered as a pain reliever with short-term action only in a mixture with an equal amount of oxygen (50% v/v nitrous oxide and 50% v/v oxygen).
Maximum administration time: no longer than 1 hour of continuous administration per day. The procedure should not be repeated for more than 15 consecutive days.
Use as a basic component of general anesthesia (anesthetic)
Nitrous Oxide AIR PRODUCTS is administered as a component of general anesthesia after mixing with at least 21% v/v oxygen. Nitrous Oxide AIR PRODUCTS at the maximum allowed concentration (79%) is not sufficient to achieve general anesthesia and is therefore used in combination with other anesthetics, inhalation or intravenous. The combination ensures faster absorption of both anesthetic gases and reduces the effective dose of the second anesthetic used (inhalation or intravenous). The effect usually starts within 2 to 5 minutes.
Before administering an intravenous anesthetic with nitrous oxide, the dose of that anesthetic should be calculated. In such a case, the maximum concentration of Nitrous Oxide AIR PRODUCTS administered is 70% v/v.

Follow the supplier's instructions, remembering in particular that:

• If the gas cylinder is visibly damaged or suspected of being damaged or exposed to extreme temperatures, it should not be used.
• Avoid contact with oils, fats, and other hydrocarbons.
• Use only cylinders intended for the specific gas with the appropriate equipment.

Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS

• When opening and closing the cylinder valve, do not use pliers or other tools; this will prevent damage.
• Do not modify the packaging.
• In case of a leak, immediately close the gas valve if it can be done safely. If the cylinder valve cannot be closed, leave the cylinder to empty in a safe outdoor location.
• Empty cylinders should be closed.
• Do not apply pressure to the administered gas.
• Before opening the cylinder valve, place it in a vertical position and keep it in this position during gas administration.
• Nitrous oxide can cause the sudden ignition of flammable or smoldering materials. Therefore, smoking or using open fire near the gas cylinder is prohibited.
• Nitrous oxide is a non-toxic gas, heavier than air, and increases the risk of fire. It can form explosive mixtures with flammable anesthetic gases or vapors, even in the absence of oxygen.
• Rooms where the gas is used, including central storage, distribution network, pipes, outlets, and connections, must comply with applicable regulations.
• Nitrous Oxide AIR PRODUCTS can only be administered if the pressure and flow rate of the gas from the cylinder to the patient are properly controlled.
• Nitrous Oxide AIR PRODUCTS should be administered simultaneously with medical oxygen through a secure gas mixer; the pressure of nitrous oxide in the pipes should always be lower than the pressure of oxygen.
• When using a variable mixer, it is recommended to monitor the gas concentration with an oxygen analyzer.
• After use, the cylinder should be returned to the supplier.

Instructions for using Nitrous Oxide AIR PRODUCTS

Nitrous Oxide AIR PRODUCTS can only be administered by properly trained personnel using appropriate equipment and a well-fitting face mask.
Administer only in well-ventilated rooms, using (central) gas extraction.

Overdose of Nitrous Oxide AIR PRODUCTS

Overdose of Nitrous Oxide AIR PRODUCTS may cause acute hypoxia. In case of overdose, administration of Nitrous Oxide AIR PRODUCTS should be stopped immediately and the patient should be ventilated actively or passively with air or oxygen to achieve normal oxygen concentration in the blood.

Discontinuation of Nitrous Oxide AIR PRODUCTS

After stopping the administration of Nitrous Oxide AIR PRODUCTS with medical oxygen, acute hypoxia may occur, caused by the removal of Nitrous Oxide AIR PRODUCTS from the body to the lungs. It may be necessary to ventilate with 100% medical oxygen to prevent hypoxia.
In case of any further doubts related to the use of the medication, consult a doctor.
Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS

4. Possible side effects

Like all medications, Nitrous Oxide AIR PRODUCTScan cause side effects, although they may not occur in everyone.
Frequency of side effects:

• Very common (may occur more frequently than in 1 in 10 patients)
• Common (may occur no more frequently than in 1 in 10 patients)
• Uncommon (may occur no more frequently than in 1 in 100 patients)
• Rare (may occur no more frequently than in 1 in 1000 patients)
• Very rare (may occur no more frequently than in 1 in 10,000 patients)
• Unknown (frequency cannot be determined based on available data)

These side effects are classified by system and organ. Exact data on the frequency of side effects are not available, but the frequency increases with the dose and frequency of administration. Nausea and vomiting are the most commonly observed side effects.
Blood and lymphatic system disorders:
There are reports of serious changes in the total number of blood cells (megaloblastic anemia, granulocytopenia) after administration for more than 24 hours. It is believed that single exposure not longer than 6 hours does not pose a risk.
Cardiac disorders:
Nitrous Oxide AIR PRODUCTS may rarely cause cardiac rhythm disorders and heart failure.
Congenital, familial, and genetic disorders:
There are reports of very rare cases of congenital anomalies in children of medical and paramedical personnel with repeated exposure.
Ear disorders:
Temporary increase in pressure and/or volume of the middle ear (frequent).
Eye disorders:
(Frequent) Temporary increase in pressure and/or volume of the eye, eye pain, blockage of the retinal artery (supplies blood to the retina) and vision loss.
Gastrointestinal disorders:
Nausea and vomiting (very common).
Temporary increase in pressure and/or volume of the intestines and abdominal cavity.
General disorders and administration site conditions:
Gait disturbances (very rare).
Hepatobiliary disorders:
Very rarely, liver cell death (necrosis) has been observed.
Injury, poisoning, and procedural complications:
Cerebral hyperperfusion syndrome and complications related to the medical equipment used (increased pressure in gas-filled balloons) (very rare).
Metabolism and nutrition disorders:
Very rarely, vitamin B12 deficiency and increased homocysteine levels in the blood (hyperhomocysteinemia) have been observed (may occur after single exposure not longer than 6 hours).
Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS
Musculoskeletal and connective tissue disorders:
Muscle weakness (very rare).
Nervous system disorders:
Paralysis, degeneration (subacute combined degeneration) of the spinal cord, simultaneous damage to multiple peripheral nerves (polyneuropathy) (rare).
Bardzo rzadko u osób bez niedoboru witaminy B12, po pojedynczej ekspozycji nie dłuższej niż 6 godzin, obserwowano osłabienie obu nóg (paraparezję), zaburzenia rdzenia kręgowego (mielopatię) i uszkodzenie nerwu obwodowego (neuropatię obwodową).
Padaczka, wzrost ciśnienia śródczaszkowego, zaburzenia mózgu (encefalopatia), zaburzenia czucia, nieprawidłowe odruchy, ból głowy i obniżony poziom przytomności (bardzo rzadkie).
Uogólnione napady padaczkowe o nieznanej częstości występowania
Wpływ na czynność nerwów, uczucie drętwienia i osłabienia, zwykle w nogach (częstość nieznana).
Psychiatric disorders:
Sometimes, false or distorted sensory perceptions (hallucinations) occur. Hallucinations may appear if other anesthetics are not used simultaneously. However, nitrous oxide is usually used in combination, as it only supports the anesthetic effect.
Psychoses (severe mental disorders limiting control over one's own behavior and actions), confusion, euphoria, and anxiety (very rare).
Dependence (frequency unknown)
Reproductive system and breast disorders:
There are reports of very rare cases of infertility in medical and paramedical personnel with repeated exposure.
Respiratory, thoracic, and mediastinal disorders:
For a few minutes after stopping the administration of nitrous oxide, hypoxia may occur (very common).
Collapse of the lungs and air in the thoracic cavity (pneumothorax) (very rare).
Vascular disorders:
Hypotension, shock (very rare).

Reporting side effects

If any side effect worsens or if any side effect not listed in the leaflet occurs, tell your doctor.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS

5. How to store Nitrous Oxide AIR PRODUCTS

The medication should be stored out of sight and reach of children.
Do not use Nitrous Oxide AIR PRODUCTSafter the expiration date stated on the label. The expiration date refers to the last day of the given month.

• The gas cylinders should be stored at a temperature between -25°C and +65°C. The gas cylinders should be stored in a vertical position. Cylinders with a rounded bottom should be stored in a vertical position in a lattice box.
• Protect the gas cylinders from falling or shocks, for example, by securing them or placing them in a lattice box.
• The gas cylinders should be stored in well-ventilated rooms. Do not store them in the same room as flammable materials.
• Store gas cylinders containing a different type of gas, e.g., medical oxygen, or gas composition separately.
• It is recommended to store empty and full cylinders separately.
• Do not store gas cylinders near heat sources.
• Cover the gas cylinders during storage and protect them from atmospheric influences.
• Do not allow contact with fats, oils, and hydrocarbons.
• The gas cylinder valves are equipped with a safety membrane that prevents the cylinder from bursting at high internal pressure. The safety membrane may be damaged by too high a temperature, which will cause the contents of the cylinder to escape. In such a case, do not enter the room where the cylinder is stored and ventilate it properly until the danger is removed by a specialist.

6. Contents of the packaging and other information

What does Nitrous Oxide AIR PRODUCTS contain

• The active substance is nitrous oxide, 100% v/v.
• The product does not contain other ingredients.

What does Nitrous Oxide AIR PRODUCTS look like and what does the packaging contain

• Liquefied Nitrous Oxide AIR PRODUCTS is supplied in cylinders under its own pressure. The cylinder body is blue.
• In cylinders containing x liters of Nitrous Oxide AIR PRODUCTS, there are y kilograms of this gas (converted to mass) at a temperature of 15°C.

Some packaging sizes may not be available in your country.
Leaflet accompanying the packaging of Nitrous Oxide AIR PRODUCTS

Marketing authorization holder and manufacturer

Marketing authorization holder:
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Air Products Sp. z o.o.
ul. Komitetu Obrony Robotników 48
02-146 Warsaw
Manufacturer:
Air Products spol. s r.o.

• J. Š. Baara 2063/21 405 02 Děčín Czech Republic

Air Products S.A.S.
Zone Industrielle de l’Epinoy – 59175 Templemars
France
Carburos Metálicos – Aranjuez
Carretera de Toledo 7 - 28300 Aranjuez (Madrid)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Distikstofoxide Medicinaal AIR PRODUCTS, 100% v/v, medicinaal gas, vloeibaar gemaakt - RVG 32959
Czech Republic:
Medicinální oxid dusný Air Products, 100% obj., plyn pro inhalaci v kapalném skupenství formě
Portugal: Protóxido de azoto medicinal da GASIN, 100% v/v, gás de inalação no estado liquefeito sob pressão
Slovakia: Oxid dusný medicinálny AIR PRODUCTS 100% V/V plyn na inhaláciu
Hungary:
Dinitrogén-oxid Air Products cseppfolyósított orvosi gáz, 100 térfogatszázalék, orvosi gáz, cseppfolyósított

Date of last revision of the leaflet: