Podtlenek azotu Messer

Leaflet attached to the packaging: patient information

NITROUS OXIDE MESSER, not less than 98.0% (V/V), medical gas liquefied

Dinitrogenii oxidum

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Nitrous Oxide Messer and what is it used for
• 2. Important information before using Nitrous Oxide Messer
• 3. How to use Nitrous Oxide Messer
• 4. Possible side effects
• 5. How to store Nitrous Oxide Messer
• 6. Package contents and other information

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

Nitrous Oxide Messer (chemical formula: N2O) is a colorless and odorless gas.
It is used to induce and maintain general anesthesia.
Nitrous Oxide Messer is always administered in a mixture with oxygen or other inhalational or intravenous anesthetics.
The mixture of Nitrous Oxide Messer with oxygen, commonly known as "laughing gas",
is used to achieve a pain-relieving effect caused by shallow anesthesia without loss of consciousness (e.g., obstetric analgesia).

2. Important information before using Nitrous Oxide Messer

When not to use Nitrous Oxide Messer

• if the patient is allergic to nitrous oxide;
• without added oxygen or in a breathing mixture containing less than 30% oxygen;
• in a mixture with oxygen used for more than 24 hours;
• in case of vitamin B12 deficiency;
• during methotrexate therapy;
• in patients with impaired consciousness;
• in case of air embolism;
• in case of head injuries associated with increased intracranial pressure;
• in case of maxillofacial injuries;
• in case of decompression sickness;
• in patients with increased intracranial pressure;
• in case of untreated pneumothorax, regardless of type;
• during middle ear, inner ear, or paranasal sinus surgery;
• in case of significant abdominal distension (e.g., acute intestinal obstruction);
• in patients who have undergone intraocular gas injection (e.g., SF6 or C3F8), until the gas bubble is absorbed from the eye or for 3 months after the last gas injection into the eye;
• in case of upper respiratory tract inflammation and other disorders limiting the patency of the nasal airway (common cold, pharyngitis, otitis, sinusitis);
• in case of tonsil hypertrophy and associated oral breathing;
• in case of eating a meal immediately before the procedure;
• in case of bronchiectasis, pulmonary emphysema;
• in case of alcoholism, psychosis;
• in case of congenital heart defects;
• in case of multiple sclerosis;
• in case of porphyria;
• in case of muscle fatigue;

Warnings and precautions

The doctor will exercise particular caution when using Nitrous Oxide Messer and will take appropriate action in patients:

• with severe lung function disorders (hypoxemia);
• with severe heart failure;
• with increased intracranial pressure;
• with hypovolemia (reduced circulating blood volume);
• in shock. Nitrous oxide has the ability to penetrate body cavities filled with air (e.g., paranasal sinuses, middle ear, existing pneumothorax) causing an increase in their volume or pressure. Nitrous oxide penetrates through plastic elements, e.g., during anesthesia with intubation (insertion of a plastic tube into the patient's trachea), entering the cuff of the endotracheal tube. This may consequently lead to airway obstruction. If ventilation is performed with air and not pure oxygen, in the final phase of anesthesia, when nitrous oxide quickly penetrates from the blood into the alveolar space, diffusive hypoxia may occur. If the patient abuses drugs currently or has abused them in the past, 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 Messer. Repeated 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 attending physician may order a blood test before and after treatment to assess the effects of possible vitamin B12 deficiency. Rooms where nitrous oxide is used must be equipped with an appropriate gas disposal or ventilation system to keep the nitrous oxide concentration at a minimal level and below the established national occupational exposure limits. In Poland, the NSD (Maximum Permissible Concentration) value at the workplace for nitrous oxide has been established and is 90 mg/m

Nitrous Oxide Messer and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take, if possible and your condition allows.
The effect of Nitrous Oxide Messer on the action of other medicines:

• Nitrous oxide enhances the action of medicines that act depressively on the central nervous system. Concurrent use of nitrous oxide and opioids (very strong painkillers such as morphine or similar) weakens the strength of heart contractions (negative inotropic effect).
• Nitrous oxide enhances the chemotherapeutic effect of methotrexate.

The effect of other medicines on the action of Nitrous Oxide Messer:

• Naloxone (a medicine with an effect opposite to that of opioids) weakens the pain-relieving effect of Nitrous Oxide Messer.

In case of concurrent use of Nitrous Oxide Messer and other inhalational anesthetics, the demand for the administered anesthetic is reduced.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a child, consult your doctor before using Nitrous Oxide Messer.
Nitrous Oxide Messer should not be used in the first and second trimester of pregnancy. Nitrous oxide penetrates the placenta, and the depth of fetal anesthesia corresponds to maternal anesthesia.
Avoid using nitrous oxide in breastfeeding women.
The use of Nitrous Oxide Messer during pregnancy and breastfeeding will be decided by the doctor.
Prolonged stay in the area where nitrous oxide is used may cause impaired fertility (concerns medical personnel).

Driving and using machines

After anesthesia with Nitrous Oxide Messer, do not drive vehicles or operate machines.
The period of inability to perform these activities will be decided by the doctor, individually for each case.

3. How to use Nitrous Oxide Messer

Nitrous Oxide Messer is always administered by trained personnel familiar with this form of the medicine. During the administration of Nitrous Oxide Messer, both the patient and the administration of the medicine should be monitored to ensure safe use. After the administration is completed, the patient should be under the supervision of competent personnel until full consciousness is regained.
The doctor should explain to the patient what the use of Nitrous Oxide Messer involves, how it works, and what its effects are.
Nitrous Oxide Messer is used inhalationally - the patient takes the medicine by inhaling it through a face mask or endotracheal tube.
Using Nitrous Oxide Messer:

• induction of general anesthesia - inhalation of a breathing mixture, 70% of which is nitrous oxide and 30% oxygen;
• maintaining general anesthesia - inhalation of a breathing mixture, 30-70% of which is nitrous oxide and the rest oxygen;
• in obstetrics (as a pain reliever) - inhalation of a breathing mixture, 25-50% of which is nitrous oxide and the rest oxygen.

Limitations in the method of dosing result from the adverse reactions caused by Nitrous Oxide Messer and concomitant diseases (severe heart failure, lung function disorders, increased intracranial pressure).

Using a higher dose of Nitrous Oxide Messer than recommended

Overdose is possible in case of improper monitoring of vital functions.
It manifests as cyanosis, bradycardia (slow heart rate), decreased blood pressure, and decreased arterial blood oxygen saturation. The procedure in case of overdose involves administering pure oxygen. There is no specific antidote.

4. Possible side effects

Like all medicines, Nitrous Oxide Messer can cause side effects, although they may not occur in everyone.

The following side effects of the medicine have been observed: Frequent (may affect up to 1 in 10 patients):

• nausea and vomiting
• euphoria, mood disorders, dizziness, or fainting
• decreased red blood cell oxygen saturation in children

Uncommon (may affect up to 1 in 100 patients):

• bloating
• feeling of pressure in the middle ear

Rare (may affect up to 1 in 1000 patients):

• heart rhythm disorders, bradycardia (slow heart rate), pulmonary hypertension, hypotension in newborns, diffuse myocardial hypoxia immediately after nitrous oxide inhalation
• in case of administration for more than 24 hours - decreased red blood cell count, caused by vitamin B12 and/or folate deficiency, decreased white blood cell count
• non-inflammatory spinal cord disease, non-inflammatory polyneuropathy, increased intracranial pressure, muscle spasms, headache
• temporary cessation of breathing, bronchospasm

Frequency not known (frequency cannot be estimated from available data)

• generalized seizures
• effect on nerve function, feeling of numbness and weakness, usually in the legs
• addiction

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Nitrous Oxide Messer

Nitrous Oxide Messer should be stored in a place inaccessible to children. Do not use the medicine after the expiration date stated on the label after "Expiration date".
Personnel handling the cylinders with the medicine should be properly trained and aware of the hazards resulting from the physicochemical properties of the product.

6. Package contents and other information

What Nitrous Oxide Messer contains

• The active substance is nitrous oxide. The content of nitrous oxide is not less than 98.0% (V/V).
• The medicine does not contain other ingredients.

What Nitrous Oxide Messer looks like and what the package contains

Nitrous Oxide Messer is a colorless and odorless medical gas in liquid form.
It is stored in steel cylinders with a capacity of 10 l and 40 l.

Marketing authorization holder:

Messer Polska Sp. z o.o., ul. Maciejkowicka 30, 41-503 Chorzów, tel. (32) 77 26 000, fax (32) 77 26 115, e-mail [email protected]

Manufacturer:

Messer Polska Sp. z o.o., ul. Maciejkowicka 30, 41-503 Chorzów. For more detailed information, please contact the representative of the marketing authorization holder. Messer Polska Sp. z o.o., ul. Maciejkowicka 30, 41-503 Chorzów, tel. (32) 77 26 000, fax (32) 77 26 115, e-mail: [email protected]

Date of last update of the leaflet:

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS:

NITROUS OXIDE MESSER, not less than 98.0% (V/V), medical gas liquefied

Dinitrogenii oxidum

Instructions for preparing the medicinal product for use and disposing of its residues

General recommendations:

Never use oils or lubricants - even if the cylinder valve is stuck or connecting the regulator is difficult. Valves and fittings should be handled with clean, non-greasy hands (e.g., no hand creams). Only use standard fittings dedicated to Nitrous Oxide Messer.
Before using the cylinder containing Nitrous Oxide Messer, check if the seal (heat-shrinkable foil) protecting the valve is intact.

Preparation for use:

Before use, the cylinder should be stored at a temperature of 15-20°C for at least 6 hours.
Before connecting the fittings, remove the seal (foil) protecting the valve.
Only use regulators intended for Nitrous Oxide Messer. Check if the valve and regulator nozzles are clean and in good condition.
Never use tools for securing pressure or flow regulators designed for manual securing, as this may damage the connection.
Open the cylinder valve slowly - open it for at least one turn.
According to the regulator's instructions, check if there is any gas leak.
Do not attempt to prevent leakage from the valve or fittings in any way other than by replacing the seals, using only original parts.
In case of persistent leakage, close the cylinder valve and disconnect the regulator. Mark the damaged cylinder, set it aside, and return it to the supplier.

Using the medical gas Nitrous Oxide Messer from a cylinder:

Nitrous Oxide Messer should be administered using appropriate fittings, ensuring gas flow through the airways and allowing, if necessary, immediate resuscitation of the patient.
Smoking and using open fire in areas where Nitrous Oxide Messer is used are strictly prohibited.
During use, the cylinder should be secured against tipping over in an appropriate holder.
After completing the use of the cylinder, close its valve using normal hand force. Release the gas remaining in the regulator or the hose connecting the regulator to the installation.
If the pressure in the cylinder drops significantly (to about 3 to 5 bar), consider it empty, close the valve, and disconnect the fittings. Leave the residual pressure in the cylinder to prevent contamination.

Special precautions for storing cylinders containing Nitrous Oxide Messer:

Nitrous Oxide Messer should be stored only in cylinders that meet the requirements of the Technical Supervision Authority.

• Cylinders with Nitrous Oxide Messer should be stored in a ventilated area, away from heat sources and flammable gases or other flammable substances.
• Cylinders should be stored and transported at a temperature below 50°C.
• Cylinders secured against tipping over should be stored in a vertical position.
• The warehouse organization should allow for the separation of different types of gases, as well as empty and full cylinders.
• A cylinder should be considered empty when the pressure in the cylinder at room temperature drops to 3 to 5 bar.