Podtlenek Azotu Medihni Spavmet

Leaflet attached to the packaging: patient information

Medical Nitrous Oxide SPAWMET

(Dinitrogen oxide)

98%, medical gas, liquefied

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on 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 or pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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

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

Medical Nitrous Oxide is a medicinal product and belongs to the group of other general anesthetics. For medical use only. Administered by inhalation. It is a colorless, odorless gas with a sweet smell and oxidizing properties. It is found in a cylinder or container in a liquefied state.
Indications:

• auxiliary drug in general anesthesia, in combination with other anesthetic agents administered intravenously or by inhalation,
• auxiliary analgesic drug in shallow anesthesia without loss of consciousness during short, painful medical procedures, e.g. injuries, burns, autoanalgesia during childbirth, dental procedures, dermatological procedures, otolaryngological surgery.

2. Important information before using Medical Nitrous Oxide

Nitrous oxide should not be administered without the addition of oxygen and in a breathing mixture containing less than 30% oxygen.

When not to use Medical Nitrous Oxide :

• to patients requiring ventilation with pure oxygen;
• in any pathological conditions where air is trapped inside the body and its excessive expansion could be dangerous (e.g. pneumothorax or pneumoperitoneum);
• to a patient who has recently been given eye gases (SF, CF, CF) during eye surgery, as the gas bubble remains in the eye for a period of at least 3 months; severe postoperative complications related to increased intraocular pressure may occur.

in the eye;

• disorders of consciousness that make it difficult to cooperate with the patient;
• increased intracranial pressure;
• acute intestinal obstruction;
• facial injuries in the area where the mask is to be placed.

Warnings and precautions:

• intraocular injection, after which you should wait for a certain amount of time to avoid the risk of vision disorders,
• in patients with heart failure, if hypotension or heart failure occurs during nitrous oxide administration, nitrous oxide administration should be stopped immediately,
• during bleomycin treatment, as increased oxygen levels during inhalation sedation increase the risk of lung toxicity,
• sickle cell anemia,
• Addison-Biermer anemia, Crohn's disease,
• during childbirth, when it is not recommended to administer the medicinal product in combination with opioids, as it lowers the level of consciousness,
• after nasal or middle ear surgery.

Medical Nitrous Oxide and other medicines

• Orally or intravenously administered sedatives or anesthetics enhance the effect of Medical Nitrous Oxide.
• Opioid derivatives (opioids) have an additive analgesic and sedative effect in relation to Medical Nitrous Oxide.
• Benzodiazepines and barbiturates (a group of drugs with a sedative and/or muscle relaxant effect) enhance the effect of Medical Nitrous Oxide.
• Certain muscle relaxants (e.g. pancuronium, vecuronium) enhance the effect of Medical Nitrous Oxide.
• Medical Nitrous Oxide deactivates vitamin B12, which increases the toxicity of sodium nitroprusside (a medicine for hypertension) and methotrexate (a medicine used, among others, in rheumatism and cancer).
• Bleomycin (an anticancer drug) increases the risk of lung damage associated with increased oxygen levels during anesthesia.

Medical Nitrous Oxide with food and drink

If Medical Nitrous Oxide is used as an anesthetic, you should avoid taking food or drinks from the previous day's midnight. Medical Nitrous Oxide, used alone or with other medicines, may cause nausea or vomiting.

Pregnancy, breastfeeding, and fertility

Animal studies have shown a harmful effect of long-term administration of nitrous oxide on the development of offspring. The potential risk to humans is not known. Nitrous oxide should not be used during pregnancy (especially in the first and second trimester), unless it is absolutely necessary. Frequent or prolonged administration should be avoided. There is no data on the penetration of nitrous oxide into breast milk. After short-term administration of nitrous oxide, it is not necessary to interrupt breastfeeding.

Driving and using machines

Nitrous oxide significantly reduces the ability to drive vehicles and operate machines. After completing short-term administration of nitrous oxide for pain relief, you should wait until you regain full consciousness before the administration of nitrous oxide. After complete anesthesia with nitrous oxide in combination with another anesthetic or analgesic, it is recommended to wait 24 hours.

3. How to use Medical Nitrous Oxide

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor.
The agent can only be administered by qualified personnel in a well-ventilated room. Current guidelines and safety and hygiene regulations regarding Medical Nitrous Oxide should be followed, especially among pregnant women belonging to the personnel.

• Medical Nitrous Oxide, as an auxiliary drug in general anesthesia, in combination with other anesthetic agents administered intravenously or by inhalation, should be administered only by inhalation after mixing with oxygen (at least 21%). If a second inhaled anesthetic is used, its dosage depends on the amount of nitrous oxide administered (% by volume). The dosage of the second inhaled anesthetic can be calculated from the formula: Dosage = MAC (100% - % nitrous oxide).
• Medical Nitrous Oxide, as an auxiliary analgesic drug in shallow anesthesia without loss of consciousness during short, painful medical procedures, e.g. injuries, burns, autoanalgesia during childbirth, dental procedures, dermatological procedures, otolaryngological surgery, should be administered by inhalation, in a mixture with oxygen, at a concentration between 50 and 70%. When using the medicinal product Medical Nitrous Oxide outside the operating room, the risk of loss of consciousness and coma increases. In such a situation, the administration of the medicinal product Medical Nitrous Oxide as an analgesic is only allowed in a mixture with medical oxygen. Equipment that allows the safe administration of mixtures containing medical nitrous oxide and medical oxygen, while maintaining a minimum of 30% medical oxygen, should be used. The induction time is 2 to 5 minutes. The administration time in a mixture with oxygen should not be longer than 24 hours.

Personnel handling nitrous oxide cylinders should be properly trained and aware of the hazards resulting from the physicochemical properties of the product. Before use, the cylinder should be placed in a vertical position at room temperature (15-20°C) for at least 6 hours. Before screwing the threaded connector of the reducer onto the cylinder, the valve should be opened briefly to remove any dust particles. After mounting the reducer on the cylinder, the sealing ring of the threaded connector should be checked. Then, the valve on the cylinder should be opened and the flowmeter adjusted to the required flow rate during the applied therapy (2-6 l/min). The valves of empty cylinders should be closed. A cylinder should be considered empty when the pressure in the cylinder at room temperature drops to 2 bar and the weight of the cylinder approaches the net weight stamped on the packaging. Residual pressure should be left in the cylinder to prevent contamination. Empty or partially used cylinders should be returned to the manufacturer. In case of cylinder damage or valve leakage, the valve should be closed and the reducer disconnected. The damaged cylinder should be marked and returned to the supplier. Using cylinders and containers not in accordance with their intended purpose and filling them by the user or third parties is prohibited.

Using a higher dose of Medical Nitrous Oxide than recommended

In case of overdose, the administration of the medicinal product should be stopped immediately and the patient should be ventilated actively or passively with air or oxygen until normal oxygen saturation is achieved.

Stopping the use of Medical Nitrous Oxide

After completing the administration of Medical Nitrous Oxide with medical oxygen, acute hypoxia may occur, caused by the removal of Medical Nitrous Oxide 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 medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, Medical Nitrous Oxide can cause side effects.
Known side effects have been classified according to the system and organ classification. It is difficult to present these side effects according to their frequency, as no systematic studies have been conducted on this subject. Each group of side effect frequency has been classified in order from the most severe to the mildest effect.
Frequency of side effects:

• very common (in more than 1 in 10 patients)
• common (in more than 1 in 100 patients, but less than 1 in 10 patients)
• uncommon (in more than 1 in 1,000 patients, but less than 1 in 100 patients);
• rare (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients)
• very rare (in less than 1 in 10,000 patients)
• unknown (frequency cannot be determined based on available data)

Very common:

Gastrointestinal disorders:
nausea and vomiting
Respiratory, thoracic, and mediastinal disorders:
hypoxia (for a few minutes after the end of administration)

Common:

Ear disorders:
temporary increase in pressure and/or volume of the middle ear
Eye disorders:
temporary increase in pressure and/or volume of the eye, eye pain, blockage of the retinal artery (supplies blood to the back of the eye) and vision loss
Gastrointestinal disorders:
temporary increase in pressure and/or volume of the intestines and spaces in the abdominal cavity

Uncommon:

Psychiatric disorders:
false or distorted sensory perceptions (hallucinations), which may occur if other anesthetic agents are not used concurrently; however, nitrous oxide is usually used in combination, as it only supports the anesthetic effect

Rare:

Nervous system disorders:
paralysis, degeneration (subacute combined degeneration) of the spinal cord, simultaneous damage to several peripheral nerves (polyneuropathy)

Very rare:

Blood and lymphatic system disorders:
decrease in red blood cell count, caused by a deficiency of vitamin B12 and/or folic acid (megaloblastic anemia), decrease in white blood cell count in the blood (granulocytopenia) after administration for more than 24 hours; it is believed that a single exposure not longer than 6 hours does not pose a risk
Cardiac disorders:
arrhythmias and heart failure
Congenital, familial, and genetic disorders:
occurrence of congenital defects in children of medical and paramedical personnel with repeated exposure.
General disorders and administration site conditions:
gait disturbances
Hepatobiliary disorders:
liver cell death (necrosis)
Injury, poisoning, and procedural complications:
hyperperfusion syndrome of the brain and complications related to the medical equipment used (increased pressure in gas-filled balloons)
Metabolism and nutrition disorders:
vitamin B12 deficiency and increased homocysteine levels in the blood (hyperhomocysteinemia) (may occur after a single exposure not longer than 6 hours)
Musculoskeletal and connective tissue disorders:
muscle weakness occurs
Nervous system disorders:
in people without vitamin B12 deficiency, after a single exposure not longer than 6 hours, weakness of both legs (paraparesis), spinal cord disorders (myelopathy), and peripheral nerve damage (peripheral neuropathy) have been observed
seizures, increased intracranial pressure, brain disorders (encephalopathy), sensory disturbances, abnormal reflexes, headache, and decreased level of consciousness
Psychiatric disorders:
psychoses (severe mental disorders, limiting control over one's own behavior and actions), confusion, euphoria, and anxiety
Reproductive system and breast disorders:
infertility of medical and paramedical personnel with repeated exposure.
Respiratory, thoracic, and mediastinal disorders:
lung collapse and air in the thoracic cavity (pneumothorax)
Vascular disorders:
hypotension, shock

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Medical Nitrous Oxide

Store in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the specified month.
Cylinders should be stored in a ventilated area, away from heat sources and flammable gases and other flammable substances. Cylinders should be protected from overheating. Cylinders secured against tipping over should be stored in a vertical position. Store at a temperature below +50°C. Protect valves and reducers from contamination with fats or oils.
Nitrous oxide is a non-toxic, flammable gas, heavier than air. It can form explosive mixtures with flammable anesthetic gases or vapors, even in the absence of oxygen.
Before taking the cylinder for use, check if the heat-shrinkable film is intact. The content of nitrous oxide in the cylinder should be checked by weight. Valves should be opened without using pliers or other tools to avoid pressure shock. Only equipment suitable for nitrous oxide should be used. After use, the valves of empty cylinders should be closed. After use, the cylinder should be returned to the supplier. Using cylinders and containers not in accordance with their intended purpose and filling them by the user or third parties is prohibited.

6. Contents of the packaging and other information

What does Medical Nitrous Oxide contain

• The active substance of the medicine is nitrous oxide, not less than 98.0% by volume.
• The medicine does not contain any other substances.

What does Medical Nitrous Oxide look like and what does the packaging contain

Nitrous oxide is stored exclusively in cylinders and containers that meet the requirements of the Office of Technical Inspection or Transport Technical Inspection:

• cylinders with a capacity of 0.4 l - 50 l,
• pressure vessels 50 kg - 45 tons.

Cylinders made of steel, aluminum, or other materials intended for contact with nitrous oxide (composites) that meet the requirements of the Office of Technical Inspection or Transport Technical Inspection. Cylinders equipped with a valve with a standardized connector socket. Conversion to mass at 15°C: 1 liter of nitrous oxide corresponds to 0.75 kg of this gas. Standardized color: cylinder head painted blue. Not all packaging sizes may be on the market. For detailed information, please contact the marketing authorization holder.

Marketing authorization holder and manufacturer

SPAWMET Sp. z o.o.
ul. Zakładowa 8
89-600 Chojnice

Date of last update of the leaflet: