Nitrous oxide messer

Package leaflet: Information for the patient

NITROUS OXIDE MESSER, not less than 98.0% (V/V), liquefied medical gas
Dinitrogenii oxidum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor, pharmacist, or nurse if you have any questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

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. Contents of the pack and other information

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

Nitrous Oxide Messer (chemical formula: N₂O) is a colourless and odourless gas.
It is used to induce and maintain general anaesthesia.
Nitrous Oxide Messer is always administered in combination with oxygen or with other inhalational or intravenous anaesthetic agents (anaesthetics).
The mixture of Nitrous Oxide Messer with oxygen, commonly known as "laughing gas", is used to achieve analgesic effect caused by light sedation without loss of consciousness (e.g. during labour analgesia).

2. Important information before using the medicinal product Nitrous Oxide Messer

When not to use Nitrous Oxide Messer

• if the patient is allergic to nitrous oxide;
• without the addition of oxygen or in a breathing mixture containing less than 30% oxygen;
• in a mixture with oxygen used for longer than 24 hours;
• in cases of vitamin B12 deficiency;
• during methotrexate therapy;
• in patients with impaired consciousness;
• in cases of air embolism;
• in head injuries associated with increased intracranial pressure;
• in maxillofacial injuries;
• in decompression sickness;
• in patients with elevated intracranial pressure;
• in untreated pneumothorax, regardless of type;
• during surgery of the middle ear, inner ear, or paranasal sinuses;
• in 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 remains in the eye or for 3 months after the last intravitreal gas injection; Page 1 of 7
• in upper respiratory tract infections and other conditions impairing nasal airway patency (e.g. cold, pharyngitis, otitis, sinusitis);
• in cases of tonsillar hypertrophy and associated mouth breathing;
• after eating a meal immediately before the procedure;
• in bronchiectasis, pulmonary emphysema;
• in alcohol-related disease, psychosis;
• in congenital heart defects;
• in multiple sclerosis;
• in porphyria;
• in muscle fatigue;

Warnings and precautions
The physician must exercise special caution when administering Nitrous Oxide Messer and take appropriate measures in patients:

• with severe pulmonary dysfunction (hypoxemia);
• with severe heart failure;
• with elevated intracranial pressure;
• with hypovolemia (reduced circulating blood volume);
• in shock.

Nitrous oxide has the ability to diffuse into body cavities filled with air (e.g. paranasal sinuses, middle ear, existing pneumothorax), causing an increase in volume or pressure. Nitrous oxide can permeate through components made of plastic materials, for example during anesthesia with intubation (insertion of a plastic tube into the patient’s trachea), diffusing into the inflatable cuff of the endotracheal tube. This may consequently lead to airway obstruction. If ventilation is performed with air rather than pure oxygen, in the final phase of anesthesia, when nitrous oxide rapidly diffuses from blood into alveolar spaces, diffusion hypoxia may occur. If the patient currently abuses or has previously abused drugs, there is an increased risk of developing dependence on nitrous oxide with repeated use. The attending physician will decide whether treatment with Nitrous Oxide Messer is appropriate for a given 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 attending physician may order blood tests before and after treatment to assess potential effects of vitamin B12 deficiency.

Rooms where nitrous oxide is used must be equipped with an appropriate gas evacuation system or ventilation to maintain nitrous oxide concentration at the lowest possible level and below established national occupational exposure limits. In Poland, the Maximum Allowable Concentration (MAC) for nitrous oxide at the workplace has been established at 90 mg/m³.

Nitrous Oxide Messer and other medicines
Inform the physician about all medicines currently used or recently used, as well as any medicines the patient plans to use, if possible and if the patient’s condition allows.

Effect of Nitrous Oxide Messer on the action of other medicines:

• Nitrous oxide enhances the effect of drugs that depress the central nervous system. Concurrent use of nitrous oxide and opioids (very strong analgesics such as morphine or similar drugs) reduces cardiac contractility (negative inotropic effect).
• Nitrous oxide enhances the chemotherapeutic effect of methotrexate.

Effect of other medicines on the action of Nitrous Oxide Messer:

• Naloxone (a drug that counteracts opioids) reduces the analgesic effect of Nitrous Oxide Messer.

When Nitrous Oxide Messer is used concurrently with other inhaled anesthetic agents, the requirement for the administered anesthetic agent is reduced.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a physician before using Nitrous Oxide Messer.

Nitrous Oxide Messer should not be used during the first and second trimesters of pregnancy. Nitrous oxide crosses the placenta, and the depth of fetal anesthesia corresponds to that of the mother. Use of nitrous oxide in breastfeeding women should be avoided.

The decision on using Nitrous Oxide Messer during pregnancy and breastfeeding will be made by the physician.

Prolonged exposure to nitrous oxide in the workplace may impair fertility (applies to medical personnel).

Driving and operating machinery
After anesthesia with Nitrous Oxide Messer, patients must not drive or operate machinery. The physician will determine the duration of inability to perform these activities on an individual basis for each case.
Page 2 of 7

3. How to use Nitrous Oxide Messer

Nitrous Oxide Messer is always administered by trained personnel familiar with this medicinal product. During administration of Nitrous Oxide Messer, both the patient and the administration process must be monitored to ensure safe use. After administration has ended, the patient should remain under the supervision of competent personnel until full consciousness is regained.

The physician should explain to the patient the nature of the use of Nitrous Oxide Messer, how it works, and what effects may occur.

Nitrous Oxide Messer is administered by inhalation – the patient inhales the gas through a face mask or endotracheal tube.

Use of Nitrous Oxide Messer:

• Induction of general anaesthesia – inhalation of a breathing mixture containing 70% nitrous oxide and 30% oxygen;
• Maintenance of general anaesthesia – inhalation of a breathing mixture containing 30% to 70% nitrous oxide and the remainder oxygen;
• In obstetrics (as an analgesic) – inhalation of a breathing mixture containing 25% to 50% nitrous oxide and the remainder oxygen.

Page 3 of 7
Dosing limitations arise from adverse effects caused by Nitrous Oxide Messer and from concomitant diseases (severe cardiac insufficiency, impaired lung function, increased intracranial pressure).

Administration of a higher than recommended dose of Nitrous Oxide Messer
Overdose is possible if vital functions are inadequately monitored. It manifests as cyanosis, bradycardia (slowing of heart rate), decreased arterial blood pressure, and reduced arterial oxygen saturation. Management of overdose consists of administering pure oxygen. There is no specific antidote.

4. Possible adverse reactions

Like all medicines, Podtlenek azotu Messer may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed with this medicine:
Common (may affect up to 1 in 10 patients):

• nausea and vomiting
• euphoria, mood disturbances, dizziness or fainting
• reduced oxygen saturation of haemoglobin in children

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

• abdominal distension
• sensation of pressure in the middle ear

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

• cardiac arrhythmias, bradycardia (slowing of the heart rate), pulmonary hypertension, arterial hypotension in newborns, diffuse myocardial hypoxia immediately after discontinuation of nitrous oxide inhalation
• when administered for longer than 24 hours – decreased red blood cell count due to vitamin B12 and/or folic acid deficiency, decreased white blood cell count in blood
• non-inflammatory spinal cord disease, non-inflammatory polyneuropathy, increased intracranial pressure (pressure within the skull), muscle spasms, headache
• transient respiratory arrest, bronchoconstriction

Frequency unknown (frequency cannot be estimated from available data):

• generalized epileptic seizures
• effects on nerve function, sensation of numbness and weakness, usually in the legs
• dependence

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 Adverse reactions can also be reported to the marketing authorization holder.

Page 4 of 7
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Podtlenek azotu Messer

Podtlenek azotu Messer should be stored in a place inaccessible to children. Do not use
the medicinal product after the expiry date stated on the label following: "Expiry date".
Persons handling cylinders containing the medicinal product should be adequately trained and aware of the
hazards arising from the physicochemical properties of the product.

6. Contents of the package and other information

What Podtlenek azotu Messer contains

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

What Podtlenek azotu Messer looks like and contents of the pack
Podtlenek azotu Messer is a colourless and odourless liquefied medical gas. It is stored in steel cylinders with a capacity of 10 l and 40 l.

Marketing Authorisation 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 Authorisation 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]

INFORMATION INTENDED EXCLUSIVELY FOR PROFESSIONAL MEDICAL PERSONNEL

NITROUS OXIDE MESSER, not less than 98.0% (V/V), liquefied medical gas
Dinitrogenii oxidum
Page 5 of 7
Instructions for preparation of the medicinal product prior to use and for disposal of residues

General recommendations:
Never use oils or greases—even if the cylinder valve sticks or connecting the reducer is difficult. Valves and connected equipment must be handled with clean, grease-free hands (e.g., without hand creams). Use only standard equipment dedicated for the medicinal product Nitrous Oxide Messer.

Before drawing from a cylinder containing Nitrous Oxide Messer, check that the valve seal (heat-shrink foil) is intact.

Preparation for use:
Before use, the cylinder should be kept at a temperature of 15–20°C for at least 6 hours.
Before connecting the equipment, remove the protective seal (foil) from the valve.
Use only pressure or flow regulators designed specifically for Nitrous Oxide Messer. Check that the valve outlet and regulator connections are clean and in good condition.
Never use tools to tighten pressure or flow regulators intended for hand-tightening only, as this may damage the connection.
Open the cylinder valve slowly—open it by at least one full turn.
Following the instructions provided with the regulator, check for any gas leakage.
Do not attempt to stop leaks from the valve or equipment by any method other than replacing seals, using only original spare parts.
If a leak persists, close the cylinder valve, disconnect the regulator, clearly mark the cylinder as damaged, set it aside, and return it to the supplier.

Administration of Nitrous Oxide Messer medical gas from cylinder:
Nitrous Oxide Messer must be administered using appropriate equipment ensuring gas flow through the respiratory tract and allowing, if necessary, immediate resuscitation of the patient.
Smoking and the use of open flames are strictly prohibited in areas where Nitrous Oxide Messer is used.
During use, the cylinder must be secured against falling in an appropriate holder.
After use, close the cylinder valve using normal hand force. Release the gas remaining in the regulator or connecting hose.
When cylinder pressure drops significantly (to approximately 3 to 5 bar), consider the cylinder empty, close the valve, and disconnect the equipment. A residual pressure of this level should be maintained in the cylinder to prevent contamination.

Page 6 of 7

Special precautions regarding storage of cylinders containing Nitrous Oxide Messer:

Nitrous Oxide Messer must be stored exclusively in cylinders meeting Technical Supervision requirements.

• Cylinders containing Nitrous Oxide Messer must be stored in a well-ventilated area, away from sources of heat, flammable gases, and other combustible materials.
• Cylinders must be stored and transported at temperatures below 50°C.
• Cylinders must be stored in an upright position and secured against falling.
• The storage facility layout should allow for segregation of different types of gases, as well as separation of empty and full cylinders.
• A cylinder should be considered empty when the pressure at room temperature drops to 3 to 5 bar.

Page 7 of 7