Nitric oxide Messer 800 ppm (v/v) medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Nitric oxide Messer 800ppm (v/v) medicinal compressed gas

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nitric oxide Messer is and what it is used for
2. What you need to know before starting treatment with Nitric oxide Messer
3. How to use Nitric oxide Messer
4. Possible adverse 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 for the treatment of:

• Newborns with respiratory failure associated with high pulmonary arterial pressure, a condition known as hypoxic respiratory failure. When inhaled, this gas mixture can improve blood flow through the lungs, which may help increase the amount of oxygen reaching your child's blood.
• Newborns, infants, children, adolescents from 0 to 17 years of age, and adults with pulmonary hypertension associated with cardiac surgery. This gas mixture may improve cardiac function and increase blood flow through the lungs, which may help increase the amount of oxygen reaching the blood.

Nitric Oxide Messer must only be administered by healthcare professionals.

2. What you need to know before starting treatment with Nitric Oxide Messer

Do not use Nitric Oxide Messer

• If you (as patient) or your child (as patient) are allergic (hypersensitive) to nitric oxide or to any of the other components of this medicine (listed in section 6);
• If you have been told that you (as patient) or your child (as patient) have abnormal blood circulation in the heart.

Warnings and precautions

Talk to your doctor or nurse before you or your child are administered Nitric Oxide Messer.

Inhaled nitric oxide is not always effective, and therefore other treatments may need to be considered for you or your child.

Inhaled nitric oxide may affect the blood's ability to carry oxygen (formation of so-called "methemoglobin"). This will be monitored through blood tests, and if necessary, the dose of inhaled nitric oxide should be reduced.

Nitric oxide may react with oxygen to form nitrogen dioxide, which can cause irritation of the airways. Your doctor or your child's doctor will monitor nitrogen dioxide levels, and if high levels occur, treatment with Nitric Oxide Messer will be adjusted and reduced accordingly.

Inhaled nitric oxide may slightly affect the blood platelets (components of blood involved in clotting) in you or your child, and signs of bleeding or bruising should be monitored. If you notice any signs or symptoms that may be associated with bleeding, inform the doctor immediately.

Cases of fluid retention in the lungs have been reported with nitric oxide in patients who have a disease caused by a blocked or narrowed vein in the lungs. If you (as patient) or your child (as patient) experience shortness of breath or difficulty breathing, contact your doctor immediately.

Children

No effect of inhaled nitric oxide has been documented in newborns with a birth defect in which the diaphragm is not fully formed, called "congenital diaphragmatic hernia".

In newborns with special heart malformations, what doctors call "congenital cardiac defects", inhaled nitric oxide may cause worsening of circulation.

Nitric Oxide Messer must not be used in premature newborns less than 34 weeks gestational age.

Use of Nitric Oxide Messer with other medicines

The doctor will decide when to treat you or your child with Nitric Oxide Messer and other medicines, and will carefully monitor the treatment.

Inform your doctor if you (as patient) or your child (as patient) are taking or have recently taken or used any other medicines.

Some medicines may affect the blood's ability to carry oxygen. These include prilocaine (a local anesthetic to relieve pain associated with minor painful procedures, e.g., suturing and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain). Your doctor will ensure that the blood can carry sufficient oxygen when these medicines are being used.

Concomitant use of nitric oxide and vasodilators (medicines used to widen blood vessels) such as sildenafil may have additive effects on blood circulation, pulmonary pressure, or heart activity.

Pregnancy and breastfeeding

Nitric Oxide Messer is not recommended during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.

Consult your doctor or pharmacist before taking this medicine.

Driving and use of machines

Not applicable

Nitric Oxide Messer contains nitrogen.

3. How to use Nitric Oxide Messer

Your doctor will decide what the correct dose of Nitric Oxide Messer is.

Nitric Oxide Messer is administered at a dose of 10 to 20 ppm (parts per million) of the gas inhaled by you or your child. The maximum dose is 20 ppm in children and 40 ppm in adults. The lowest effective dose will be administered.

Method of administration

Your doctor will administer Nitric Oxide Messer into your lungs or those of your child using a system designed to deliver this gas. This delivery system will ensure the correct dose of nitric oxide is administered by diluting Nitric Oxide Messer with an oxygen/air mixture immediately before administration. For your safety or that of your child, delivery systems intended for Nitric Oxide Messer administration are equipped with devices that continuously measure the amount of nitric oxide, oxygen, and nitrogen dioxide (a chemical compound formed when nitric oxide and oxygen are mixed) delivered to the lungs.

Duration of treatment

Your doctor will decide how long you or your child should receive treatment with Nitric Oxide Messer.

Treatment usually lasts about 4 days in newborns with pulmonary failure associated with high pulmonary arterial pressure. In children and adults with high pulmonary arterial pressure following cardiac surgery, Nitric Oxide Messer is typically administered for 24–48 hours. However, treatment with Nitric Oxide Messer may last longer.

If you or your child uses more Nitric Oxide Messer than you should

Excessive inhaled nitric oxide may affect the blood's ability to carry oxygen. This will be monitored through blood tests, and if necessary, the dose of Nitric Oxide Messer will be reduced and medications such as vitamin C, methylene blue, or ultimately a blood transfusion may be considered to improve oxygen-carrying capacity.

Nitric Oxide Messer treatment must not be stopped suddenly. It is known that sudden interruption of Nitric Oxide Messer treatment without prior dose reduction may cause low blood pressure or rebound increase in pulmonary pressure.

At the end of treatment, your doctor will gradually reduce the amount of Nitric Oxide Messer administered to you or your child, allowing the pulmonary circulation to adjust to oxygen/air without Nitric Oxide Messer. Therefore, it may take one or two days until you or your child stops receiving Nitric Oxide Messer treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Your doctor will closely monitor you or your child to detect any adverse effects.

The very common adverse effects (may affect more than 1 in 10 people) observed in connection with nitric oxide treatment are:

• Low platelet count.

The common adverse effects (may affect up to 1 in 10 people) observed in connection with nitric oxide treatment are:

• Low blood pressure, collapsed or airless lung.

The uncommon adverse effects (may affect up to 1 in 100 people) that may occur are:

• Increased methemoglobin, therefore reduced capacity to carry oxygen.

Adverse effects with unknown frequency (cannot be estimated from the available data) that may occur are:

• Bradycardia (slow heart rate) or abnormally low levels of oxygen in the blood (oxygen desaturation/hypoxemia) due to sudden withdrawal of treatment.
• Headache, dizziness, dry throat, or breathing difficulty following accidental exposure to nitric oxide in ambient air (e.g., equipment or cylinder leakage).

You should inform the medical staff directly if you experience headache while being near the child receiving Nitric Oxide Messer treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nitric Oxide Messer

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Store below 50°C.

Nitric Oxide Messer therapy must only be used and handled by hospital personnel.

• Nitric Oxide Messer gas cylinders must be kept secured to prevent falling and, therefore, the risk of causing injury.

• Nitric Oxide Messer must only be used and administered by personnel specifically trained in the use and handling of Nitric Oxide Messer.

All regulations concerning the handling of pressurized containers must be followed.

Store in the original gas cylinder. Do not transfer the contents of the original gas cylinder to another gas cylinder.

Store gas cylinders in well-ventilated indoor rooms or ventilated outdoor shelters, protected from rain and direct sunlight.

Protect gas cylinders from impact, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.

Storage in the pharmacy department

Gas cylinders must be stored in a well-ventilated, clean, and locked area, exclusively designated for the storage of medicinal gases, protected from rain and direct sunlight. Within this area, there must be a separate, dedicated installation for the storage of nitric oxide gas cylinders.

Storage in the medical department

The gas cylinder must be placed in a location equipped with appropriate equipment to ensure it remains upright.

Transport of gas cylinders

Gas cylinders must be transported using appropriate materials to protect them from the risk of impact or falling.

During patient transfer treated with Nitric Oxide Messer, either between different hospitals or within the same hospital, gas cylinders must be securely fastened to remain upright and to avoid the risk of falling or unintended changes in medication administration. Special attention must also be paid to securing the pressure regulator to prevent the risk of accidental malfunction.

Do not dispose of the gas cylinder when empty. Empty gas cylinders will be collected by the supplier.

6. Contents of the container and other information

Composition of Nitric Oxide Messer

The active substance is nitric oxide 800 ppm (v/v).

A 2-litre gas cylinder filled at 200 bar absolute contains 381 litres of gas under a pressure of 1 bar at 15 °C.

A 10-litre gas cylinder filled at 200 bar absolute contains 1903 litres of gas under a pressure of 1 bar at 15 °C.

A 20-litre gas cylinder filled at 200 bar absolute contains 3806 litres of gas under a pressure of 1 bar at 15 °C.

The other component is nitrogen.

Appearance of the product and contents of the container

Nitric Oxide Messer is a compressed medicinal gas.

Aluminium gas cylinders of 2 litres, 10 litres, and 20 litres (identified by turquoise upper part and white body), filled at a pressure of 200 bar, equipped with a stainless steel residual pressure valve with a specific outlet connection.

Nitric Oxide Messer is available in aluminium gas cylinders of 2 litres, 10 litres, and 20 litres.

Marketing Authorisation Holder

Messer Ibérica de Gases S.A.U.
Autovía Tarragona-Salou, km. 3.8
E-43480, Vilaseca (Tarragona)
Spain

Manufacturer

Messer Austria GmbH
Industriestraße 5
2352 Gumpoldskirchen
Austria

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Stickstoffmonoxid Messer 800 ppm (V/V) Gas zur medizinischen Anwendung, druckverdichtet
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, stlacen
Slovenia: Medicinski dušikov oksid Messer 800 ppm (V/V) medicinski plin, stisnjeni
Spain: Nitric Oxide Messer 800 ppm (v/v) compressed medicinal gas
France: Monoxyde d'azote Messer 800 ppm (V/V) gaz médicinal comprimé
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
Czech Republic: Oxid dusnatý Messer 800 ppm (V/V) medicinální plyn, stlačený
Slovakia: Oxid dusnatý Messer 800 ppm (V/V) medicinálny plyn stlačený

Date of the most recent revision of this leaflet: May 2025