Nitrous oxide messer

Package leaflet: Information for the user

Nitric Oxide Messer 800 ppm (V/V) medicinal compressed gas
Nitrogenii oxidum
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Nitric Oxide Messer contains nitric oxide, a gas used in the treatment of:

• newborns with hypoxic respiratory failure, i.e. lung failure associated with high blood pressure in the lungs. Inhaled gas mixture may improve blood flow in the lungs, thereby increasing the amount of oxygen delivered to the child's blood;
• newborns, infants, children and adolescents aged 0 to 17 years, and adults with high blood pressure in the lungs related to heart surgery. The gas mixture may improve heart function and increase blood flow through the lungs, thereby increasing the amount of oxygen delivered to the blood.

Nitric Oxide Messer may be administered only by qualified medical personnel.

2. Important information before using Tlenek azotu Messer

When not to use Tlenek azotu Messer

• If the patient is allergic (hypersensitive) to nitric oxide or any of the other ingredients of this medicine (listed in section 6).
• If the patient has been informed that they have abnormal blood circulation within the heart.

Warnings and precautions
Before starting treatment with Tlenek azotu Messer, discuss this with the doctor or nurse.
Inhaled nitric oxide may not always be effective; therefore, alternative therapy should be considered in adult or pediatric patients.
Inhaled nitric oxide may affect the blood's ability to carry oxygen (formation of so-called "methemoglobin"). This process will be monitored in blood samples, and if necessary, the dose of inhaled nitric oxide must be reduced.
Nitric oxide may react with oxygen, forming nitrogen dioxide, which may cause irritation of the respiratory tract. The physician will monitor nitrogen dioxide concentrations and, if elevated levels occur, the dose of Tlenek azotu Messer will be appropriately reduced.
Inhaled nitric oxide may slightly affect platelets (blood cells responsible for blood clotting); therefore, any signs of bleeding or bruising should be observed. If signs or symptoms possibly related to bleeding are observed, the physician should be informed immediately.
Cases of pulmonary fluid accumulation associated with nitric oxide use have been reported in patients with disease caused by blockage or narrowing of the pulmonary veins. If the patient (adult or child) develops shortness of breath or difficulty breathing, contact the physician immediately.

Children
Clinical studies have not demonstrated efficacy of inhaled nitric oxide in newborns with congenital diaphragmatic hernia.
In newborns with specific heart defects (congenital heart defects), inhaled nitric oxide may lead to deterioration of circulation.
Tlenek azotu Messer must not be used in preterm infants born before 34 weeks of gestation.

Tlenek azotu Messer and other medicines
The physician will decide when to administer Tlenek azotu Messer together with other medications in adult or pediatric patients and will closely monitor the treatment.
Inform the physician about all medicines currently used or recently used by the patient, including those obtained without a prescription.
Some medicines may affect the blood's ability to carry oxygen. These include prilocaine (a local anesthetic used to relieve pain during minor painful procedures such as suturing and minor surgical or diagnostic procedures) or nitroglycerin (used in the treatment of chest pain). The physician will check whether sufficient oxygen is being carried by the blood during treatment with these medicines.
Concomitant administration of nitric oxide with vasodilating drugs (e.g. sildenafil) may have an additive effect on the circulatory system, pulmonary pressure, and heart function.

Pregnancy and breastfeeding
Tlenek azotu Messer is not recommended for use during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her physician before using this medicine.
Before starting any medication, discuss it with the physician or pharmacist.

Driving and operating machinery
Not applicable.

Tlenek azotu Messer contains nitrogen.

3. How to use Tlenek azotu Messer

The appropriate dose of Tlenek azotu Messer will be determined by your doctor.
Tlenek azotu Messer is administered at a dose of 10 to 20 ppm (parts per million) of inhaled gas.
The maximum dose is 20 ppm in children and 40 ppm in adults. The dose will be adjusted to ensure
the lowest effective dose is used.

Method of administration
Your doctor will deliver Tlenek azotu Messer to the patient's lungs using a dedicated gas delivery system.
This system ensures the correct amount of nitric oxide is delivered by diluting Tlenek azotu Messer with a mixture of oxygen and air immediately before administration. For patient safety, Tlenek azotu Messer delivery systems are equipped with sensors that continuously monitor the levels of nitric oxide, oxygen, and nitrogen dioxide (a chemical compound formed when nitric oxide mixes with oxygen) delivered to the lungs.

Duration of treatment
Your doctor will decide how long the treatment with Tlenek azotu Messer will last for an adult or child.
Treatment typically lasts approximately 4 days in newborns with respiratory failure due to pulmonary hypertension. In children and adults with pulmonary hypertension associated with heart surgery, Tlenek azotu Messer is usually administered for 24 to 48 hours. However, therapy with Tlenek azotu Messer may last longer.

Overdose of Tlenek azotu Messer
Excessive amounts of inhaled nitric oxide may affect the blood's ability to carry oxygen. This will be monitored through blood samples, and if necessary, the dose of Tlenek azotu Messer will be reduced. Your doctor may consider administering medications such as vitamin C, methylene blue, or blood transfusions to improve the blood's oxygen-carrying capacity.

Discontinuation of Tlenek azotu Messer treatment
Treatment with Tlenek azotu Messer should not be stopped abruptly. It is known that sudden discontinuation of Tlenek azotu Messer without prior dose reduction may lead to low blood pressure or rebound pulmonary hypertension.
Towards the end of treatment, your doctor will gradually reduce the amount of Tlenek azotu Messer administered, allowing the pulmonary circulation to adapt to the oxygen-air mixture without Tlenek azotu Messer. Therefore, discontinuation of Tlenek azotu Messer therapy may take one or two days.

If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects,
although not everyone will experience them. The doctor will carry out detailed examinations to monitor
for any adverse effects.
The following very common adverse effects (may occur in more than 1 in 10 people) are associated with
treatment with nitric oxide:

• Low platelet count.

The following common adverse effects (may occur in less than 1 in 10, but more than 1 in 100 people) are associated with treatment with nitric oxide:

• Low blood pressure, reduced air volume in the lungs, or lung collapse.

The following uncommon adverse effects (may occur in less than 1 in 100, but more than 1 in 1000 people) may occur:

• Increased methemoglobin concentration, which is associated with reduced ability of the blood to carry oxygen.

The following adverse effects may occur, but their frequency is unknown (frequency cannot be estimated from available data):

• Bradycardia (slow heart rate) or low oxygen levels in the blood (poor blood oxygenation: hypoxemia) as a result of sudden discontinuation of treatment.
• Headache, dizziness, dry throat, or shortness of breath following accidental exposure to nitric oxide in the environment (e.g. leakage from equipment or cylinder).

If someone near a child receiving Tlenek azotu Messer experiences headache, medical staff should be informed immediately.
If any of the adverse effects worsen, or if any adverse effects not listed in this leaflet occur—even after completion of treatment in hospital—inform the doctor.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store the medicinal product Tlenek azotu Messer

The medicinal product should be stored in a place inaccessible and not visible to children.
Do not use the medicinal product after the expiry date stated on the label following: Expiry date.
The expiry date refers to the last day of the stated month.
Store below 50°C.
Observe all regulations regarding the handling of pressurized containers.

• Cylinders containing the medicinal product Tlenek azotu Messer must be stored secured to prevent tipping over and potential injury.
• The medicinal product Tlenek azotu Messer must be administered and handled exclusively by personnel specially trained in the use and handling of Tlenek azotu Messer.

Keep in the original cylinder. Do not transfer the contents from the original cylinder to another cylinder.
Gas cylinders must be stored in well-ventilated areas indoors or outdoors in utility rooms with adequate ventilation, protected from rain and direct sunlight.
Cylinders must be protected from shocks, falls, oxidizing materials and flammable substances, moisture, and sources of heat or fire.
Storage in the hospital pharmacy
Gas cylinders must be stored in well-ventilated, clean, and lockable rooms intended exclusively for the storage of medicinal gases, protected from rain and direct sunlight. A separate area within the room must be designated for cylinders containing nitrous oxide.
Storage on medical wards
The gas cylinder must be placed in a location allowing the cylinder to remain in an upright position.
Transport of gas cylinders
During transport, gas cylinders must be properly secured to avoid the risk of shocks or falls. When transporting patients treated with Tlenek azotu Messer to another ward or hospital, gas cylinders must be appropriately secured in an upright position to prevent the cylinder from tipping over or changes in the amount of gas delivered. Particular attention must be paid to securing the pressure regulator properly to prevent accidental malfunction.
Do not dispose of empty cylinders. Empty cylinders must be returned to the supplier.

6. Package contents and other information

What Tlenek azotu Messer contains
The active substance is nitric oxide 800 ppm (V/V).
A two-litre cylinder filled under an absolute pressure of 200 bar provides 381 litres of gas at a pressure of 1 bar at a temperature of 15°C.
A ten-litre cylinder filled under an absolute pressure of 200 bar provides 1,903 litres of gas at a pressure of 1 bar at a temperature of 15°C.
A twenty-litre cylinder filled under an absolute pressure of 200 bar provides 3,806 litres of gas at a pressure of 1 bar at a temperature of 15°C.
The remaining component is nitrogen.

What Tlenek azotu Messer looks like and contents of the pack
Tlenek azotu Messer is a compressed medicinal gas.
The two-litre, ten-litre, and twenty-litre aluminium cylinder (dome in turquoise-blue colour, white body), filled under a pressure of 200 bar, equipped with a residual pressure valve made of stainless steel and a special outlet connector.
Tlenek azotu Messer is available in two-litre, ten-litre, and twenty-litre cylinders containing gas.

Marketing Authorisation Holder
Messer Polska Sp. z o.o.
ul. Maciejkowicka 30
41-503 Chorzów
Poland

Manufacturer
Messer Austria GmbH
Industriestraße 5
2352 Gumpoldskirchen
Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Stickstoffmonoxid Messer 800 ppm (V/V) Gas zur medizinischen Anwendung, druckverdichtet
Belgium Stikstofmonoxide Messer 800 ppm (V/V), medicinaal gas, samengeperst
Croatia Dušikov (II) oksid Messer 800 ppm (V/V) medicinski plin, stlačen
Czech Republic Oxid dusnatý Messer 800 ppm (V/V) medicinální plyn, stlačený
France Monoxyde d‘azote Messer 800 ppm (V/V) gaz médicinal comprimé
Germany Stickstoffmonoxid Messer 800 ppm (V/V) Gas zur medizinischen Anwendung, druckverdichtet
Hungary Nitrogén monoxid Messer 800 ppm (V/V) túlnyomásos orvosi gáz
Poland Tlenek azotu Messer, 800 ppm (V/V), gaz medyczny sprężony
Romania Monoxid de azot Messer 800 ppm (V/V) gaz medicinal, comprimat
Slovakia Oxid dusnatý Messer 800 ppm (V/V) medicinálny plyn stlačený
Slovenia Medicinski dušikov oksid Messer 800 ppm (V/V) medicinski plin, stisnjeni
Spain Óxido nítrico Messer 800 ppm (v/v) gas comprimido medicinal