PATIENT INFORMATION LEAFLET

INOmax 400 ppm mol/mol, inhalation gas

Nitric Oxide

Read this 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, ask your doctor.
• If you experience any side effects, ask your doctor, even if they are not listed in this leaflet. See Section 4.

INOmax contains nitric oxide, a gas used for the treatment of:

• Newborns with pulmonary hypertension associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure. When inhaled, this gas mixture may improve blood flow through the lungs, which may contribute to increasing the amount of oxygen that reaches the baby's blood.

• Newborns, infants, children, and adolescents aged 0-17 years and adults with pulmonary hypertension related to cardiac surgery. This gas mixture may improve cardiac function and increase blood flow through the lungs, which may help to increase the amount of oxygen that reaches the blood.

No use INOmax:

• If you (as a patient) or your child (as a patient) are allergic (hypersensitive) to nitric oxide or to any of the components of INOmax (see the complete list of ingredients in section 6 “Additional Information”).
• If you have been informed that you (as a patient) or your child (as a patient) have abnormal heart circulation.

Tenga especial cuidado con INOmax

Inhaled nitric oxide may not always be effective, so other treatments may sometimes be considered for you or your child.

Inhaled nitric oxide may affect the blood's ability to transport oxygen. This will be monitored through blood tests, and if necessary, the dose of inhaled nitric oxide will be reduced.

Inhaled 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 nitrogen dioxide levels and, if high levels are detected, will reduce the INOmax treatment accordingly.

Inhaled nitric oxide may have a mild effect on your platelets (components that help blood to clot) or your child's platelets, so any signs of bleeding or hematoma should be closely monitored. If you observe any signs or symptoms that may be associated with bleeding, you should inform your doctor directly.

No adverse effects of inhaled nitric oxide have been documented in newborns with a congenital diaphragmatic hernia, also known ascongenital diaphragmatic hernia.

In newborns with special heart malformations, which doctors callcongenital heart disease, inhaled nitric oxide may worsen circulation.

Niños

INOmax should not be administered to premature babies with <34

Uso de INOmax con otros medicamentos:

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

Inform your doctor if you (as a patient) or your child (as a patient) are taking or have taken or recently used any other medication, including over-the-counter medications.

Some medications may affect the blood's ability to transport oxygen, such as prilocaine (a local anesthetic used to relieve pain in minor procedures, such as sutures or minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat angina). Your doctor will check that the blood contains sufficient oxygen when taking these medications.

Embarazo y lactancia

The use of INOmax is not recommended during pregnancy and lactation. Inform your doctor if you are pregnant, if you think you may be pregnant, or if you are breastfeeding before starting INOmax treatment.

Consult your doctor or pharmacist before taking a medication.

Conducción y uso de máquinas

Not relevant

INOmax contains nitrogen

Your doctor will determine the correct dose of INOmax and administer INOmax to your lungs or your child's lungs through a system designed for the administration of this gas. This administration system will ensure that the correct amount of nitric oxide is administered by diluting INOmax with a mixture of oxygen and air immediately before administration.

For your safety or your child's safety, the systems designed for the administration of INOmax are equipped with constant measurement devices for the amount of nitric oxide, oxygen, and nitrogen dioxide (a chemical substance obtained by mixing nitric oxide and oxygen) that will be administered to the lungs.

Your doctor will determine how long the treatment with INOmax should last.

INOmax is administered in doses of 10 - 20 ppm (parts per million) (maximum dose: 20 ppm in children and 40 ppm in adults) of the gas that you or your child inhale. The effective minimum dose will be sought.

Normally, a treatment of approximately 4 days is needed in newborns with pulmonary failure associated with pulmonary hypertension. In children and adults with pulmonary hypertension associated with cardiac surgery, INOmax is normally administered for 24-48 hours. However, INOmax treatment may be prolonged.

If you or your child receive more INOmax than you should

An excessive amount of inhaled nitric oxide can affect the ability of the blood to transport oxygen. This value will be evaluated through blood analysis, and if necessary, the dose of INOmax and medications such as vitamin C, methylene blue, or, if necessary, a blood transfusion will be considered to improve oxygen transport.

If you interrupt the treatment with INOmax

The treatment with INOmax should not be interrupted suddenly. It has been seen that hypotension or a rebound increase in pulmonary pressure can occur when the treatment with INOmax is interrupted suddenly without having previously reduced the dose.

At the end of treatment, the doctor will gradually reduce the amount of INOmax administered to you or your child, so that the circulation in the lungs can adjust to oxygen/air without the need for INOmax. This process may take a day or two before you or your child have completed the administration of INOmax entirely.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Your doctor will examine you or your child thoroughly to determine all adverse effects.

Very frequent adverse effects(affecting more than 1 in 10 patients)associated with INOmax treatment include:

• Low platelet count.

Frequent adverse effects(affecting more than 1 in 100 patients)associated with INOmax treatment include:

• Hypotension, pulmonary collapse, or lack of air in the lungs.

Adverse effects that may be observed, which are infrequent(affecting between 1 in 100 and 1 in 1000 patients)are:

• Increased methemoglobin, and therefore reduced oxygen transport capacity.

Observed adverse effects of unknown frequency(cannot be estimated from available data)are:

• Bradycardia (low heart rate) or severely low oxygen levels in the blood (hypoxemia) due to sudden interruption of treatment.
• Headache, dizziness, dry throat, or respiratory difficulties after accidental exposure to nitric oxide environment (i.e., equipment or gas cylinder leaks).

You should inform the staff directly if you experience a headache while near your child when receiving INOmax.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this leaflet, even after you or your child leaves the hospital, inform your doctor.

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 leaflet. You can also report them directly tothe national reporting system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date indicated on the label below CAD. The expiration date refers to the last day of the month in question.

INOmax treatment should only be administered and managed by hospital personnel.

• INOmax vials must be stored safely to prevent falls and, as a consequence, possible damage.
• INOmax must be handled and administered only by personnel specifically trained in

the use and handling of INOmax.

Regulations related to the handling of compressed gas cartridges must be respected.

Storage is supervised by hospital specialists. Store gas cartridges in well-ventilated rooms or covered, ventilated shelters and protected from rain and direct sunlight.

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

Storage in the pharmacy department

Gas cartridges must be stored in a well-ventilated, clean, and locked area, exclusively for the storage of medicinal gases. Within this area, there must be a separate installation for the storage of nitrogen oxide gas cartridges.

Storage in the medical department

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

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

INOmax Composition

The active ingredient of INOmax is nitric oxide 400 ppm mol/mol. A 2-liter gas cylinder filled at 155 bar absolute contains 307 liters of gas at 1 bar pressure at 15°C.oC.

A 10-liter gas cylinder filled at 155 bar absolute contains 1535 liters of gas at 1 bar pressure at 15oC.

The other ingredient is nitrogen.

INOmax Presentation and Packaging

Inhalation gas

2-liter aluminum gas cylinder (identification with blue-green cap and white body) filled at 155 bar pressure, with stainless steel positive pressure (residual) valve with a specific connection for outlet and a standard valve handle.

2-liter aluminum gas cylinder (identification with blue-green cap and white body) filled at 155 bar pressure, with stainless steel positive pressure (residual) valve with a specific connection for outlet and a valve handle equipped with INOmeter device.

10-liter aluminum gas cylinder (identification with blue-green cap and white body) filled at 155 bar pressure, with stainless steel positive pressure (residual) valve with a specific connection for outlet and a standard valve handle.

10-liter aluminum gas cylinder (identification with blue-green cap and white body) filled at 155 bar pressure, with stainless steel positive pressure (residual) valve with a specific connection for outlet and a valve handle equipped with INOmeter device.

INOmax is presented in the form of 2-liter and 10-liter aluminum gas cylinders.

Authorized Representative and Manufacturer

Authorized Representative

Authorized Representative

Linde Healthcare AB

Rättarvägen 3

169 68 Solna

Sweden

Manufacturer

Linde France

Z.I. Limay-Porcheville 3 avenue Ozanne 78440 Porcheville France

Porcheville France

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: MM/AAAA

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu