INOMAX 800 PPM MOL/MOL, COMPRESSED MEDICAL GAS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

INOmax 800 ppm mol/mol, medicinal gas

nitric oxide

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.
• If you experience any side effects, talk to your doctor, even if you think they are not related to this medicine, see section 4.

Contents of the pack:

1. What INOmax is and what it is used for
2. What you need to know before you use INOmax
3. How to use INOmax
4. Possible side effects
5. Storage of INOmax
6. Contents of the pack and other information

1. What INOmax is and what it is used for

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 can improve blood flow through the lungs, which can help increase the amount of oxygen that reaches the baby's blood.

• newborns, infants, children, and adolescents from 0 to 17 years and adults with pulmonary hypertension related to cardiac surgery.

This gas mixture can improve cardiac function and increase blood flow in the lungs, which can help increase the amount of oxygen that reaches the blood.

2. What you need to know before you use INOmax

Do not use INOmax:

• If you (as a patient) or your child (as a patient) are allergic (hypersensitive) to nitric oxide or any of the components of INOmax (see section 6 "Further information" for the complete list of ingredients).

Be cautious with INOmax

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

Inhaled nitric oxide can 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.

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 levels, and if high values are detected, the treatment with INOmax will be reduced accordingly.

Inhaled nitric oxide may have a mild effect on your platelets (components that help blood clot) or those of your child, so any signs of bleeding or bruising should be monitored. If you notice any signs or symptoms that may be associated with bleeding, you should inform your doctor immediately.

No effects of inhaled nitric oxide have been documented in newborns with a congenital diaphragmatic hernia.

In newborns with certain congenital heart defects, inhaled nitric oxide may worsen circulation.

Children

INOmax should not be administered to premature babies with less than 34 weeks of gestation.

Use of INOmax with other medicines:

Your doctor will decide when to treat you or your child with INOmax and other medications 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 any other medications, including those obtained without a prescription.

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Not relevant

INOmax contains nitrogen

3. How to use INOmax

Your doctor will determine the correct dose of INOmax and administer INOmax to your lungs or those of your child 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 that of your child, the systems intended 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 minimum effective dose will be sought. Normally, treatment is needed for approximately 4 days in newborns with pulmonary failure associated with pulmonary hypertension. In children and adults with pulmonary hypertension associated with cardiac surgery, INOmax is usually administered for 24-48 hours. However, treatment with INOmax may be extended.

If you or your child receive more INOmax than you should

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

If you stop using INOmax

Treatment with INOmax should not be stopped suddenly. It has been seen that hypotension or a rebound increase in pulmonary pressure can occur when treatment with INOmax is stopped abruptly without previously reducing the dose.

At the end of treatment, your 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 can take a day or two before you or your child have completely finished administering INOmax.

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

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 carefully to determine all side effects.

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

• Low platelet count.

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

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

Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 patients) are:

• Increased methemoglobin, and therefore reduced oxygen transport capacity.

Side effects with unknown frequency (cannot be estimated from available data) are:

• Bradycardia (low heart rate) or excessively low oxygen level in the blood (oxygen desaturation/hypoxemia) due to sudden interruption of treatment.

• Headache, dizziness, dry throat, or respiratory difficulties after accidental exposure to the nitric oxide environment (i.e., equipment leaks or gas cylinder leaks).

You should inform the staff directly if you suffer from headaches while near your child when they receive INOmax.

If you think any of the side effects are serious or if you notice any side effects not mentioned in this leaflet, including after you or your child have left the hospital, inform your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not mentioned in this leaflet. You can also report them directly to the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of INOmax

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 in question.

Treatment with INOmax should only be administered and handled by hospital personnel.

• The INOmax gas cylinders should be stored safely to avoid falls and, as a consequence, possible damage.

INOmax should only be handled and administered by personnel specially trained in the use and handling of INOmax.

The regulations regarding the handling of gas cylinders under pressure should be respected.

Storage is supervised by hospital specialists. Store the gas cylinders in well-ventilated rooms or sheds, protected from rain and direct sunlight.

Protect the gas cylinders from shocks, falls, oxidation, and flammable materials, humidity, and heat or ignition sources.

Storage in the pharmacy department

The gas cylinders should be stored in a well-ventilated, clean, and locked area, exclusively for the storage of medicinal gases. Within this area, there should be a separate installation for the storage of nitric oxide gas cylinders.

Storage in the medical department

The gas cylinder should be placed in an area equipped with suitable material to keep it upright.

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 INOmax

The active substance of INOmax is nitric oxide 800 ppm mol/mol. A 2-liter gas cylinder filled to 155 bar absolute contains 307 liters of gas at a pressure of 1 bar at 15°C.

A 10-liter gas cylinder filled to 155 bar absolute contains 1,535 liters of gas at a pressure of 1 bar at 15°C.

The other ingredient is nitrogen.

Presentation and contents of the pack of INOmax

Medicinal gas

2-liter aluminum gas cylinder (identified with a turquoise-colored shoulder and white body)

filled to a pressure of 155 bar, with a positive pressure (residual) valve made of stainless steel with a specific connection for outlet and a standard valve handle.

2-liter aluminum gas cylinder (identified with a turquoise-colored shoulder and white body)

filled to a pressure of 155 bar, with a positive pressure (residual) valve made of stainless steel with a specific connection for outlet and a valve handle equipped with an INOmeter device.

10-liter aluminum gas cylinder (identified with a turquoise-colored shoulder and white body)

filled to a pressure of 155 bar, with a positive pressure (residual) valve made of stainless steel with a specific connection for outlet and a standard valve handle.

10-liter aluminum gas cylinder (identified with a turquoise-colored shoulder and white body)

filled to a pressure of 155 bar, with a positive pressure (residual) valve made of stainless steel with a specific connection for outlet and a valve handle equipped with an INOmeter device.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Linde Healthcare AB

Rättarvägen 3

169 68 Solna

Sweden

Manufacturer

Linde France

Z.I. Limay-Porcheville

3 avenue Ozanne

78440 Porcheville

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet: MM/AAAA

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu