NITRIC OXIDE MESSER 800 PPM (V/V) COMPRESSED MEDICAL GAS

Introduction

Package Leaflet: Information for the User

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

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

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

Contents of the pack

1. What is Nitric Oxide Messer and what is it used for
2. What you need to know before you start treatment with Nitric Oxide Messer
3. How to use Nitric Oxide Messer
4. Possible side effects
5. Storage of 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 for the treatment of:

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

Nitric Oxide Messer can only be administered by healthcare professionals.

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

Do not use Nitric Oxide Messer

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

Warnings and precautions

Consult your doctor or nurse before you are given Nitric Oxide Messer.

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

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

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

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

There have been reports of fluid retention in the lungs with nitric oxide in patients who have a disease caused by a blocked or narrow vein in the lungs. If you (as a patient) or your child (as a 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 malformation in which the diaphragm is not fully complete, called "congenital diaphragmatic hernia".

In newborns with special heart malformations, which doctors call "congenital heart defects", inhaled nitric oxide can cause a worsening of circulation.

Nitric Oxide Messer should not be used in premature newborns under 34 weeks of gestational age.

Use of Nitric Oxide Messer with other medicines

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

Tell your doctor if you (as a patient) or your child (as a patient) are taking or have recently taken or used any other medicine.

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

The simultaneous 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 breast-feeding

It is not recommended to use Nitric Oxide Messer during pregnancy or breast-feeding.

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

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Not applicable

Nitric Oxide Messer contains nitrogen.

3. How to use Nitric Oxide Messer

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

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

Method of administration

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

Duration of treatment

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

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

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

Excess inhaled nitric oxide can affect the ability of the blood to carry oxygen. This will be monitored by means of blood tests and, if necessary, the dose of Nitric Oxide Messer will be reduced and the administration of medicines such as vitamin C, methylene blue, or, ultimately, a blood transfusion will be considered to improve oxygen-carrying capacity.

Do not stop treatment with Nitric Oxide Messer suddenly. It is known that low blood pressure or a rebound increase in pulmonary pressure occurs if treatment with Nitric Oxide Messer is stopped suddenly without first reducing the dose.

At the end of treatment, your doctor will gradually reduce the amount of Nitric Oxide Messer that is administered to you or your child, so that pulmonary circulation can adjust to oxygen/air without Nitric Oxide Messer. Therefore, it may take a day or two until you or your child stop receiving treatment with Nitric Oxide Messer.

If you have any other 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. Your doctor will examine you or your child closely to detect any side effects.

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

• Low platelet count.

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

• Low blood pressure, lung without air or collapsed.

The uncommon side effects (may affect up to 1 in 100 people)that may be observed are:

• Increased methemoglobin, therefore less ability to carry oxygen.

The side effects with frequency not known (cannot be estimated from the available data)that may be observed are:

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

You should inform the staff directly if you experience a headache while you are near the child receiving treatment with Nitric Oxide Messer.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System Website: www.notificaRAM.es. By reporting side 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 which is stated on the label after EXP. The expiry date is the last day of the month shown.

Store below 50°C.

Therapy with Nitric Oxide Messer should only be used and handled by hospital personnel.

• The Nitric Oxide Messer cylinders must be kept secured to avoid falls and, therefore, the possibility of causing damage.

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

All rules related to the handling of pressure vessels 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 outdoor shelters, protected from rain and direct sunlight.

Protect gas cylinders from impacts, falls, oxidizing and flammable materials, humidity, and heat or ignition sources.

Storage in the pharmacy department

The gas cylinders must be stored in a ventilated, clean, and locked place, exclusively for the storage of medical gas, protected from rain and direct sunlight. Within this place, there must be a separate special 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 suitable material to keep it upright.

Transport of gas cylinders

The gas cylinders must be transported with suitable material to protect them from the risk of impacts or falls.

During the transfer of patients treated with Nitric Oxide Messer, between different hospitals or within the same hospital, the gas cylinders must be well secured to keep them upright and avoid the risk of falls or inappropriate changes in medication administration. Special attention should also be paid to the fixation of the pressure regulator to avoid the risk of accidental failures.

Do not dispose of the gas cylinder when it is empty. The supplier will collect the empty gas cylinders.

6. Contents of the pack and other information

Composition of Nitric Oxide Messer

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

A 2-liter gas cylinder filled to 200 absolute bars contains 381 liters of gas at a pressure of 1 bar at 15°C.

A 10-liter gas cylinder filled to 200 absolute bars contains 1903 liters of gas at a pressure of 1 bar at 15°C.

A 20-liter gas cylinder filled to 200 absolute bars contains 3806 liters of gas at a pressure of 1 bar at 15°C.

The other component is nitrogen.

Appearance and packaging

Nitric Oxide Messer is a compressed medical gas.

Aluminum gas cylinders of 2 liters, 10 liters, and 20 liters (identified with a turquoise blue top and white body) filled to a pressure of 200 bars, equipped with a stainless steel residual pressure valve with a specific outlet connection.

Nitric Oxide Messer is available in aluminum gas cylinders of 2 liters, 10 liters, and 20 liters.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area 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 Óxido nítrico Messer 800 ppm (v/v) gas comprimido medicinal

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 sprezony

Romania Monoxid de azot Messer 800 ppm (V/V) gaz medicinal, comprimat

Czech Republic Oxid dusnatý Messer 800 ppm (V/V) medicinální plyn, stlacený

Slovak Republic Oxid dusnatý Messer 800 ppm (V/V) medicinálny plyn stlacený

Date of last revision of this leaflet:May 2025

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