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PATIENT INFORMATION LEAFLET

Information leaflet attached to the packaging: information for the user

Nitric Oxide Messer 800 ppm (V/V) compressed medical gas

Nitrogen oxide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

Nitric Oxide Messer contains nitric oxide, a gas used to treat:

• newborns with hypoxic respiratory failure, i.e., lung failure associated with high blood pressure in the lungs. Inhaling a mixture of gases can improve blood flow in the lungs, which in turn can increase the amount of oxygen delivered to the baby's blood;
• newborns, infants, children, and adolescents from 0 to 17 years of age and adults with high blood pressure in the lungs associated with heart surgery. The gas mixture can improve heart function and increase blood flow through the lungs, which can increase the amount of oxygen delivered to the blood.

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

2. Important information before using Nitric Oxide Messer

When not to use Nitric Oxide 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 circulation in the heart.

Warnings and precautions

Before starting treatment with Nitric Oxide Messer, discuss it with your doctor or nurse.
Nitric oxide inhaled may not always be effective, so other types of therapy may be considered for the adult or child patient.
Inhaling nitric oxide may affect the blood's ability to carry oxygen (forming so-called "methemoglobin"). This process will be monitored in blood samples and, if necessary, the dose of inhaled nitric oxide will be reduced.
Nitric oxide may react with oxygen to form nitrogen dioxide, which can cause respiratory irritation. The doctor will monitor the concentration of nitrogen dioxide and, if elevated concentrations occur, the dose of Nitric Oxide Messer will be reduced accordingly.
Inhaling nitric oxide may slightly affect blood platelets (cells responsible for blood clotting), so any signs of bleeding or bruising should be observed. If signs or symptoms that may be related to bleeding are noticed, the doctor should be informed immediately.
There have been reports of fluid retention in the lungs associated with the use of nitric oxide in patients with disease caused by blockage or narrowing of the pulmonary veins. If the patient (adult or child) experiences shortness of breath or difficulty breathing, they should contact their doctor immediately.

Children

Clinical trials have not shown the effectiveness of inhaled nitric oxide in newborns with a congenital defect, namely, incomplete closure of the diaphragm, so-called "congenital diaphragmatic hernia".
In newborns with certain heart defects (congenital heart defects), inhaled nitric oxide may lead to worsening circulation.
Nitric Oxide Messer should not be used in premature infants born before 34 weeks of gestation.

Nitric Oxide Messer and other medicines

The doctor will decide when to use Nitric Oxide Messer in an adult or child patient together with other medicines and will closely monitor the treatment.
Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription.
Some medicines may affect the blood's ability to carry oxygen. These include: prilocaine (a local anesthetic used to relieve pain in minor procedures, e.g., suturing, as well as minor surgical or diagnostic procedures) or nitroglycerin (used to treat chest pain). The doctor will check if the blood carries sufficient oxygen while taking these medicines.
Administering nitric oxide with vasodilating medicines (e.g., sildenafil) may have a supportive effect on the circulatory system, pulmonary pressure, and heart function.

Pregnancy and breastfeeding

Nitric Oxide Messer is not recommended for use during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Before taking any medicine, discuss it with your doctor or pharmacist.

Driving and using machines

Not relevant.

Nitric Oxide Messer contains nitrogen.

3. How to use Nitric Oxide Messer

The doctor will determine the correct dose of Nitric Oxide Messer.
Nitric Oxide Messer is administered in 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 find the smallest effective dose.

Method of administration

The doctor will introduce Nitric Oxide Messer into the patient's lungs using a system designed for administering this gas. This system ensures that the correct amount of nitric oxide is delivered by diluting Nitric Oxide Messer with a mixture of oxygen and air just before administration to the patient. For patient safety, systems for administering Nitric Oxide Messer are equipped with sensors that continuously monitor the amount of nitric oxide, oxygen, and nitrogen dioxide (a chemical compound formed by mixing nitric oxide and oxygen) delivered to the lungs.

Duration of treatment

The doctor will decide how long the adult or child patient will be treated with Nitric Oxide Messer.
Typically, treatment lasts about 4 days in newborns with lung failure associated with high blood pressure in the lungs. In children and adults with high blood pressure in the lungs associated with heart surgery, Nitric Oxide Messer is usually administered for 24 to 48 hours. However, therapy with Nitric Oxide Messer may last longer.

Using more than the recommended dose of Nitric Oxide Messer

Too much inhaled nitric oxide can affect the blood's ability to carry oxygen. This process will be monitored in blood samples and, if necessary, the dose of Nitric Oxide Messer will be reduced. The doctor will consider administering medicines such as vitamin C, methylene blue, or blood transfusion to improve oxygen delivery.

Stopping treatment with Nitric Oxide Messer

Treatment with Nitric Oxide Messer should not be stopped abruptly. It is known that sudden discontinuation of Nitric Oxide Messer without prior dose reduction may cause low blood pressure or a recurrence of increased pressure in the lungs.
At the end of treatment, the doctor will gradually reduce the amount of Nitric Oxide Messer administered to the patient so that the circulation in the lungs can adapt to a mixture of oxygen and air without Nitric Oxide Messer. Therefore, the completion of Nitric Oxide Messer therapy in a patient may take a day or two.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them. The doctor will conduct thorough examinations for the occurrence of side effects.
The following are side effects that occur very frequently (may occur in more than 1 in 10 people) in connection with nitric oxide treatment:

• Low platelet count.

The following are side effects that occur frequently (may occur in less than 1 in 10 but more than 1 in 100 people) in connection with nitric oxide treatment:

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

The following are side effects that occur not very frequently (may occur in less than 1 in 100 but more than 1 in 1,000 people):

• Increased methemoglobin concentration, which is associated with reduced blood oxygen-carrying capacity.

The following are side effects that 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 (low oxygenation: hypoxemia) due to sudden discontinuation of treatment.
• Headache, dizziness, dry throat, or shortness of breath after accidental exposure to nitric oxide in the environment (e.g., leak from a device or cylinder).

If a person near a child receiving Nitric Oxide Messer experiences a headache, they should immediately inform the staff.
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, even after hospital treatment, tell your doctor.
If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.

5. How to store Nitric Oxide Messer

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the label after: Expiry date.
The expiry date refers to the last day of the stated month.
Store in a temperature below 50°C.
Follow any guidelines for handling pressure vessels.

• Cylinders containing Nitric Oxide Messer should be stored securely to prevent them from being knocked over and causing injury.
• Nitric Oxide Messer should only be used and administered by personnel specially trained in the use and handling of Nitric Oxide Messer.

Store in the original cylinder. Do not transfer the contents of the original cylinder to another cylinder.
Cylinders with gas should be stored in well-ventilated areas inside buildings or outside in utility rooms with adequate ventilation, protected from rain and direct sunlight.

Cylinders with gas should be protected from shocks, falls, oxidizing materials, and flammable materials, moisture, and heat or fire sources.

Storage in a hospital pharmacy

Cylinders with gas should be stored in ventilated, clean, and lockable rooms, designated solely for storing medicinal gases, protected from rain and direct sunlight. A separate area should be designated for cylinders containing nitric oxide.

Storage on medical wards

The gas cylinder should be placed in a position that allows it to be kept upright.

Transporting gas cylinders

During transport, gas cylinders should be properly secured to prevent the risk of shocks or falls. When transporting patients treated with Nitric Oxide Messer to another ward or hospital, the gas cylinders should be properly secured in an upright position to prevent them from being knocked over or the amount of gas being administered from changing. Particular attention should be paid to properly securing the pressure regulator to prevent accidental failure.
Do not dispose of empty cylinders. Empty cylinders should be returned to the supplier.

6. Contents of the pack and other information

What Nitric Oxide Messer contains

The active substance is nitric oxide 800 ppm (V/V).
A 2-liter cylinder filled at an absolute pressure of 200 bar gives 381 liters of gas at a pressure of 1 bar at 15°C.
A 10-liter cylinder filled at an absolute pressure of 200 bar gives 1,903 liters of gas at a pressure of 1 bar at 15°C.
A 20-liter cylinder filled at an absolute pressure of 200 bar gives 3,806 liters of gas at a pressure of 1 bar at 15°C.
The other ingredient is nitrogen.

What Nitric Oxide Messer looks like and contents of the pack

Nitric Oxide Messer is a compressed medical gas.
The 2-liter, 10-liter, and 20-liter aluminum cylinder (turquoise-blue head, white body), filled at a pressure of 200 bar, is equipped with a stainless steel residual pressure valve with a special outlet nozzle.
Nitric Oxide Messer is available in 2-liter, 10-liter, and 20-liter gas cylinders.

Marketing authorization holder

Messer Polska Sp. z o.o.
Maciejkowicka Street 30
41-503 Chorzów
Poland

Manufacturer

Messer Austria GmbH
Industriestraße 5
2352 Gumpoldskirchen
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Names in other languages:

Austria
Nitric Oxide Messer 800 ppm (V/V) Gas zur medizinischen Anwendung, druckverdichtet
Belgium
Nitric Oxide Messer 800 ppm (V/V), medicinaal gas, samengeperst
Croatia
Nitric Oxide Messer 800 ppm (V/V) medicinski plin, stlačen
Czech Republic
Nitric Oxide Messer 800 ppm (V/V) medicinální plyn, stlačený
France
Nitric Oxide Messer 800 ppm (V/V) gaz médicinal comprimé
Germany
Nitric Oxide Messer 800 ppm (V/V) Gas zur medizinischen Anwendung, druckverdichtet
Hungary
Nitric Oxide Messer 800 ppm (V/V) túlnyomásos orvosi gáz
Poland
Nitric Oxide Messer 800 ppm (V/V) gaz medyczny sprężony
Romania
Nitric Oxide Messer 800 ppm (V/V) gaz medicinal, comprimat
Slovakia
Nitric Oxide Messer 800 ppm (V/V) medicinálny plyn stlačený
Slovenia
Nitric Oxide Messer 800 ppm (V/V) medicinski plin, stisnjeni
Spain
Nitric Oxide Messer 800 ppm (V/V) gas comprimido medicinal
Date of last revision of the leaflet:03.03.2025