Prospect: Information for the user

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

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor, pharmacist, or nurse.
• If you experience adverse effects,consult your doctor, pharmacist, or nurse, eveniftheydo not appear in this prospect. See section 4.

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

2.What you need to knowbeforestarting treatment with Nitric Oxide Messer

3.How to useNitric Oxide Messer

4.Possible adverse effects

5.Storage ofNitric Oxide Messer

6. Contents of the package and additional information

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

• Newborns with pulmonary hypertension associated with high pulmonary arterial pressure, a disease known as hypoxic respiratory failure. When inhaled, this gas mixture may improve blood flow through the lungs, which may help increase the amount of oxygen that reaches the baby's blood.
• Newborns, infants, children, adolescents from 0 to 17 years and adults with high pulmonary arterial pressure 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 that reaches the blood.

Messer Nitric Oxide can only be administered by healthcare professionals.

No use Óxido nítrico Messer

• If you (as a patient) or your child (as a patient) are allergic (hypersensitive) to nitric oxideor to any of the other components of this medication (listed 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 administeredNitric Oxide Messer.

Nitric oxide inhalation is not always effective, and other treatments may be necessary for you or your child.

Nitric oxide inhalation may affect the blood's ability to transport oxygen (formation of the so-called “methemoglobin”). This will be monitored through blood tests, and the dose of nitric oxide inhalation will be reduced if necessary.

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

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

Children

No adverse effects of nitric oxide inhalation have 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,” nitric oxide inhalation may cause a worsening of circulation.

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

Use of Nitric Oxide Messer with other medications

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

Inform your doctorif you (as a patient) or your child (as a patient)are taking orhave taken orrecently usedany other medication.

Some medications may affect the blood's ability to transport oxygen. These include prilocaine (a local anesthetic to relieve pain associated with minor procedures, e.g., sutures and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain). Your doctor will check that the blood can transport enough oxygen when you are taking these medications.

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

Pregnancy and lactation

It is not recommended to use Nitric Oxide Messer during pregnancy or during lactation.

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

Consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Not applicable

Nitric Oxide Messer contains nitrogen.

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

Messer Nitric Oxide 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 effective minimum dose will be administered.

Administration Form

Your doctor will administer Messer Nitric Oxide to your lungs or your child's lungs through a system designed to administer this gas. This administration system will ensure that the correct dose of nitric oxide is administered by diluting Messer Nitric Oxide with a mixture of oxygen/air immediately before administering it. For your safety or your child's safety, administration systems intended for the administration of Messer Nitric Oxide 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.

Treatment Duration

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

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

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

Inhaling excess nitric oxide can affect the blood's ability to transport oxygen. This will be monitored through blood tests, and if necessary, the dose of Messer Nitric Oxide will be reduced and medications such as vitamin C, methylene blue, or, if necessary, a blood transfusion, will be considered to improve oxygen transport capacity.

The treatment with Messer Nitric Oxide should not be suddenly stopped. It is known that sudden cessation of treatment with Messer Nitric Oxide can cause low blood pressure or an increase in rebound pulmonary pressure if the treatment is stopped without first reducing the dose.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.The doctor will closely examine you or your child to detect any adverse effects.

Frequent adverse effects(may affect more than 1 in 10people)observed in relation to treatment with nitric oxide are:

• Low platelet count.

Common adverse effects(may affect up to 1 in 10people)observed in relation to treatment with nitric oxide are:

• Hypotension, collapsed or airless lung.

Rare adverse effects(may affect up to 1 in 100people)that may be observed are:

• Increased methemoglobin, therefore reduced oxygen-carrying capacity.

Adverse effects of unknown frequency(cannot be estimated from available data)that may be observed are:

• Bradycardia (slow heart rate) or a low amount of oxygen in the blood (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 or cartridge leak).

You must inform the staff directly if you experience a headache while near the child receiving nitric oxide Messer treatment.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human UseWebsite: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Store below 50°C.

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

• Nitric Oxide Messer cartridges must be stored securely to prevent falls and, therefore, the risk of causing damage.

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

All guidelines for handling pressurized containers must be followed.

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

Store gas cartridges in well-ventilated interior rooms or outdoor shelters and protect them from rain and direct sunlight.

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

Conservation in the pharmacy department

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

Conservation in the medical department

The gas cartridge must be placed in a location equipped with appropriate material to maintain it upright.

Transportation of gas cartridges

Gas cartridges must be transported with the appropriate 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, gas cartridges must be securely fastened to maintain them upright and prevent the risk of falling or improper medication administration. Special attention must also be paid to securing the pressure regulator to prevent accidental failures.

Do not dispose of the gas cartridge when it is empty. The supplier will collect empty gas cartridges.

Composition of Nitric Oxide Messer

The active principle isnitric oxide 800ppm (v/v).

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

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

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

The other component isnitrogen.

Appearance of the product and contents of the container

Nitric Oxide Messer is a medicinal compressed gas.

Aluminum gas cylinders of 2liters, 10liters, and 20 liters (identification with blue-green top and white body) filled to a pressure of 200bars, equipped with a stainless steel pressure relief valve with a specific outlet connection

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

Marketing Authorization Holder

Messer Ibérica de Gases S.A.U.

Autovía Tarragona-Salou, km. 3,8

E-43480, Vilaseca (Tarragona)

Spain

Responsible for manufacturing

Messer Austria GmbH

Industriestraße 5

2352 Gumpoldskirchen

Austria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyStickstoffmonoxid Messer 800 ppm (V/V) Gas for medical use, compressed

AustriaStickstoffmonoxid Messer 800 ppm (V/V) Gas for medical use, compressed

BelgiumStikstofmonoxide Messer 800 ppm (V/V), medicinal gas, compressed

CroatiaDušikov (II) oksid Messer 800 ppm (V/V) medicinski plin, compressed

SloveniaMedicinski dušikov oksid Messer 800ppm (V/V) medicinski plin, compressed

SpainNitric Oxide Messer 800ppm (v/v) medicinal compressed gas

FranceMonoxyde d'azote Messer 800 ppm (V/V) medicinal compressed gas

HungaryNitrogén monoxid Messer 800 ppm (V/V) túlnyomásos orvosi gáz

PolandTlenek azotu Messer, 800 ppm (V/V), medicinal compressed gas

RomaniaMonoxid de azot Messer 800 ppm (V/V) medicinal compressed gas

Czech RepublicOxid dusnatý Messer 800 ppm (V/V) medicinální plyn, stlačený

Slovak RepublicOxid dusnatý Messer 800 ppm (V/V) medicinálny plyn stlačený

Date of the last review of this leaflet :January 2018

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