Nitrous oxide medical spawmet

Package leaflet: Information for the patient

Nitrous Oxide Medical SPAWMET
(Dinitrogenii oxidum)
98 %, medicinal gas, liquefied
Read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Nitrous Oxide Medical is a medicinal product and belongs to the group of other general anaesthetics. For medical use only. Administered by inhalation. It is a colourless, odourless gas with a slightly sweet odour and oxidizing properties. It is contained in a cylinder or container in liquefied form.
Indications:

• Adjuvant in general anaesthesia, in combination with other intravenous or inhalational anaesthetic agents;
• Analgesic adjuvant in superficial anaesthesia without loss of consciousness during short-term, painful medical procedures, e.g. trauma, burns, labour analgesia, dental procedures, dermatological procedures, otolaryngological surgery.

2. Important information before using the medicinal product Nitrous Oxide

Nitrous oxide must not be administered without the addition of oxygen or in a breathing mixture containing less than 30% oxygen.
When not to use Nitrous Oxide Medicinal:

• to patients requiring ventilation with pure oxygen;

• in any pathological conditions where air is trapped within the body and its excessive expansion could be dangerous (e.g. pneumothorax or pulmonary emphysema);

• to patients who have recently undergone intraocular gas injection (SF_, C__F_, C__F_) during eye surgery, as the gas bubble remains in the eye for at least 3 months; serious postoperative complications related to increased intraocular pressure may occur;

• impaired consciousness, which makes cooperation with the patient difficult;

• 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 an appropriate amount of time should be waited to avoid the risk of visual disturbances;
• in patients with heart failure, if hypotension or cardiac failure occurs during administration of nitrous oxide, administration of nitrous oxide must be immediately discontinued;
• during treatment with bleomycin, because increased oxygen concentration during inhalational sedation increases the risk of pulmonary toxicity;
• sickle cell anemia;
• Addison-Biermer anemia (pernicious anemia), Crohn's disease;
• during childbirth, when administration of the medicinal product in combination with opioids is not recommended, as it reduces the level of consciousness;
• after sinus or middle ear surgery.

Nitrous Oxide Medicinal SPAWMET and other medicinal products

• Intravenous or inhalational anesthetics or sedatives enhance the effect of Nitrous Oxide Medicinal.
• Morphine derivatives (opioids) exhibit additive analgesic and sedative effects with Nitrous Oxide Medicinal.
• Benzodiazepines and barbiturates (a group of medicinal products with sedative and/or muscle relaxant effects) enhance the effect of Nitrous Oxide Medicinal.
• Some muscle relaxants (e.g. pancuronium, vecuronium) enhance the effect of Nitrous Oxide Medicinal.
• Nitrous Oxide Medicinal deactivates vitamin B_, thereby enhancing the toxicity of sodium nitroprusside (a medicinal product for hypertension) and methotrexate (a medicinal product used, among others, in rheumatism and neoplastic diseases).
• Bleomycin (an antineoplastic medicinal product) increases the risk of lung damage due to increased oxygen concentration during anesthesia.

Nitrous Oxide Medicinal with food and drink
If Nitrous Oxide Medicinal is used as an anesthetic, intake of food or drink should be avoided from midnight on the day preceding the procedure. Nitrous Oxide Medicinal, used alone or in combination with other medicinal products, may cause nausea or vomiting.
Pregnancy, breastfeeding and fertility
Animal studies have shown harmful effects of prolonged administration of nitrous oxide on offspring development. The potential risk to humans is unknown. Nitrous oxide must not be used during pregnancy (especially in the first and second trimesters) unless absolutely necessary. Frequent or prolonged administration should be avoided.
There are no data on the passage of nitrous oxide into breast milk. After short-term administration of nitrous oxide, interruption of breastfeeding is not necessary.
Driving and operating machinery
Nitrous oxide significantly impairs the ability to drive and operate machinery. After short-term administration of nitrous oxide for pain relief, one should wait until full consciousness prior to administration is regained. After general anesthesia with nitrous oxide in combination with another anesthetic or analgesic, it is recommended to wait 24 hours.

3. How to use Nitrous Oxide Medical

This medicine should always be used as directed by a physician. In case of doubt, consult your doctor.
The product must be administered only by trained personnel in a well-ventilated area. Current safety and occupational hygiene guidelines and regulations regarding Nitrous Oxide Medical must be strictly followed, especially among pregnant women who are part of the medical staff.

• Nitrous Oxide Medical, as an adjunctive agent in general anaesthesia, combined with other intravenous or inhalational anaesthetic agents, must be administered exclusively by inhalation after mixing with oxygen (at least 21%). When a second inhalational anaesthetic is used, its dosage depends on the amount of nitrous oxide administered (in % volume). The dosage of the second inhalational anaesthetic can be calculated using the formula: Dosage = MAC (100% – % nitrous oxide).
• Nitrous Oxide Medical, as an analgesic adjunct for pain relief during shallow anaesthesia without loss of consciousness during short-term, painful medical procedures—such as trauma, burns, peripartum self-analgesia, dental procedures, dermatological procedures, or otolaryngological surgery—should be administered by inhalation in a mixture with oxygen at a concentration between 50% and 70%. When Nitrous Oxide Medical is used outside the operating room, the risk of loss of consciousness and coma increases. In such cases, administration of Nitrous Oxide Medical as an analgesic is permitted only in a mixture with medical oxygen. Equipment must be used that ensures safe delivery of mixtures containing medical nitrous oxide and medical oxygen, maintaining a minimum of 30% medical oxygen. The induction time is 2 to 5 minutes. The duration of administration in an oxygen mixture should not exceed 24 hours.

Personnel handling nitrous oxide cylinders must be adequately trained and aware of the hazards associated with the product's physicochemical properties. Before use, the cylinder should be placed in an upright position at room temperature (15–20°C) for at least 6 hours. Before attaching the threaded connector of the pressure reducer to the cylinder, briefly open the valve to remove any dust particles. After mounting the reducer on the cylinder, check the sealing ring of the threaded connector. Then open the cylinder valve and adjust the flowmeter to the flow rate required for the therapy (2–6 L/min). Empty cylinders must be closed by closing the valves. A cylinder should be considered empty when the pressure inside the cylinder at room temperature drops to 2 bar and the cylinder weight approaches the tare weight stamped on the cylinder. A residual pressure must be left in the cylinder to prevent contamination. Empty or partially used cylinders must be returned to the manufacturer. In case of cylinder damage or valve leakage, close the valve, disconnect the reducer, clearly mark the damaged cylinder, and return it to the supplier. The use of cylinders and containers for purposes other than intended, as well as refilling by the user or third parties, is strictly prohibited.

Use of a higher than recommended dose of Nitrous Oxide Medical
In case of overdose, administration of the medicinal product must be immediately discontinued, and the patient should be actively or passively ventilated with air or oxygen until normal oxygen saturation is achieved.

Discontinuation of Nitrous Oxide Medical treatment
After discontinuation of Nitrous Oxide Medical with medical oxygen, acute hypoxia may occur due to the elimination of Nitrous Oxide Medical from the body into the lungs. Ventilation with 100% medical oxygen may be necessary to prevent hypoxia.

If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicinal product, Nitrous Oxide Medical may cause adverse reactions.
Known adverse reactions have been classified according to system organ classes. It is difficult
to present these reactions by frequency of occurrence, as there have been no systematic studies
on this subject. Each frequency category has been ordered from the most severe to the mildest reaction.
Frequency of occurrence of adverse reactions:

• 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 1000 patients, but less than 1 in 100 patients)
• rare (in more than 1 in 10,000 patients, but less than 1 in 1000 patients)
• very rare (in less than 1 in 10,000 patients)
• not known (frequency cannot be estimated from available data)

Very common:
Gastrointestinal disorders:
nausea and vomiting
Respiratory, thoracic and mediastinal disorders:
hypoxia (for several minutes after discontinuation of administration)

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

Uncommon:
Psychiatric disorders:
false or distorted sensory perceptions (hallucinations), which may occur if other anaesthetic agents are not additionally used; however, nitrous oxide is usually used in combination as an adjunct to anaesthesia

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

Very rare:
Blood and lymphatic system disorders:
reduction in red blood cells due to vitamin B_(12) and/or folic acid deficiency (megaloblastic anaemia), reduction in white blood cells in blood (granulocytopenia) after administration for more than 24 hours; single exposure not exceeding 6 hours is not considered a risk
Cardiac disorders:
cardiac arrhythmias and heart failure
Congenital, familial and genetic disorders:
occurrence of congenital malformations in children of medical and paramedical staff following repeated exposure
General disorders and administration site conditions:
gait disturbances
Hepatobiliary disorders:
liver cell death (necrosis)
Injury, poisoning and procedural complications:
cerebral hyperperfusion syndrome and complications related to medical equipment used (increased pressure in gas-filled balloons)
Metabolism and nutrition disorders:
vitamin B_(12) deficiency and increased blood concentration of the amino acid homocysteine (hyperhomocysteinaemia) (may occur after a single exposure not exceeding 6 hours)
Musculoskeletal and connective tissue disorders:
muscle weakness occurs
Nervous system disorders:
in individuals without vitamin B_(12) deficiency, after a single exposure not exceeding 6 hours, weakness of both legs (paraparesis), spinal cord disorders (myelopathy), and peripheral nerve damage (peripheral neuropathy) have been observed;
epilepsy, increased intracranial pressure, brain disorders (encephalopathy), sensory disturbances, abnormal reflexes, headache, and reduced level of consciousness
Psychiatric disorders:
psychoses (severe mental disorders limiting control over one's behaviour and actions), confusion, euphoria, and anxiety
Reproductive system and breast disorders:
infertility in medical and paramedical staff following repeated exposure
Respiratory, thoracic and mediastinal disorders:
lung collapse and presence of air in the chest cavity (pneumothorax)
Vascular disorders:
hypotension, shock

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Nitrous Oxide Medicinal

Keep out of the sight and reach of 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 must be stored in a well-ventilated area, away from heat sources, flammable gases, and other combustible substances. Cylinders must be protected from heating. Cylinders secured against overturning must be stored in an upright position. Store at temperatures below +50°C. Protect valves and pressure regulators from contamination with grease or oils.
Nitrous oxide is a non-toxic gas, heavier than air, which intensifies combustion. It may form explosive mixtures with flammable anaesthetic gases or vapours, even in the absence of oxygen.
Before removing the cylinder for use, check that the heat-shrinkable foil is intact. The nitrous oxide content in the cylinder should be checked by weighing. Open valves without using pliers or other tools to avoid pressure shock. Use only equipment compatible with nitrous oxide. After use, close the valves of empty gas cylinders. Return used cylinders to the supplier.
Nitrous oxide in mixture with oxygen and possibly other inhalational or intravenous anaesthetic agents is administered by inhalation via a face mask or endotracheal tube using specialized inhalation devices or anaesthesia equipment, and dosed with a flowmeter measuring in litres per minute.

6. Contents of the packaging and other information

What the medicinal product Podtlenek Azotu Medyczny contains

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

What Podtlenek Azotu Medyczny looks like and what the packaging contains
Nitrous oxide is stored exclusively in cylinders and pressure vessels meeting the requirements of the Technical Supervision Authority or Transport Technical Supervision Authority:

• Cylinders with capacity of 0.4 l - 50 l,
• Pressure vessels of 50 kg - 45 tons.

Cylinders made of steel, aluminium or other materials intended for contact with nitrous oxide (composites), meeting the requirements of the Technical Supervision Authority or Transport Technical Supervision Authority. Cylinders equipped with a valve with a standardized connection socket.
Conversion to mass at 15°C: 1 litre of nitrous oxide corresponds to 0.75 kg of this gas.
Standardized colour: cylinder head painted blue.
Not all pack sizes may be marketed.
For detailed information, please contact the responsible entity.

Responsible entity and manufacturer
SPAWMET Sp. z o.o.
ul. Zakładowa 8
89-600 Chojnice