Inomax 400 ppm mol, medicinal compressed gas

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

INOmax 800 ppm mol/mol, medicinal compressed gas

nitric oxide

Read the 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.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What INOmax is and what it is used for
2. What you need to know before using INOmax
3. How to use INOmax
4. Possible adverse 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 respiratory failure 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 may help increase the amount of oxygen delivered to the child's blood.

• newborns, infants, children, adolescents aged 0–17 years, and adults with pulmonary hypertension related to heart surgery. This gas mixture can improve cardiac function and increase blood flow in the lungs, which may help raise the amount of oxygen delivered to the blood.

2. What you need to know before using INOmax

Do not 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 section 6 “Additional Information” for the complete list of ingredients).
• If you have been informed that you (as a patient) or your child (as a patient) have abnormal blood circulation in the heart.

Take special care with INOmax

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

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

Inhaled nitric oxide may react with oxygen and form nitrogen dioxide, which can cause irritation of the airways. Your doctor or your child's doctor will monitor nitrogen dioxide levels and, if elevated levels are detected, will appropriately reduce the INOmax treatment.

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

There is no documented effect of inhaled nitric oxide in newborns with a malformation in which the diaphragm is incomplete, known as congenital diaphragmatic hernia.

In newborns with specific heart malformations, what doctors call congenital heart disease, inhaled nitric oxide may worsen circulation.

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 a patient) or your child (as a patient) experience shortness of breath or difficulty breathing, contact your doctor immediately.

Children

INOmax must not be administered to premature infants with < 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 drugs, and will carefully monitor the treatment.

Inform your doctor if you (as a patient) or your child (as a patient) are taking, have taken, or have recently used any other medications, including medicines obtained without a prescription.

Some medicines may affect the blood's ability to carry oxygen, such as prilocaine (a local anesthetic used to relieve pain during minor painful procedures, such as suturing or minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat angina). Your doctor will check that the blood contains sufficient oxygen when these medicines are being used.

Pregnancy and breastfeeding

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 medicine.

Driving and using machines

Not applicable

INOmax contains nitrogen

3. How to use INOmax

Your doctor will determine the correct dose of INOmax and will administer INOmax to your lungs or to those of your child through a system designed for the delivery of this gas. This delivery 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, systems intended for the administration of INOmax are equipped with devices that continuously measure the amount of nitric oxide, oxygen, and nitrogen dioxide (a chemical formed when nitric oxide and oxygen are mixed) being delivered to the lungs.

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

INOmax is administered at doses of 10–20 ppm (parts per million) (maximum dose: 20 ppm in children and 40 ppm in adults) of the gas inhaled by you or your child. The lowest effective dose will be sought.

Treatment typically lasts approximately 4 days in newborns with lung 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 prescribed

An excessive amount of inhaled nitric oxide may affect the blood's ability to carry oxygen. This will be assessed by blood tests, and if necessary, the dose of INOmax will be reduced and medications such as vitamin C or methylene blue may be administered. In some cases, blood transfusion may be considered to improve oxygen-carrying capacity.

If treatment with INOmax is interrupted

Treatment with INOmax must not be stopped suddenly. Sudden interruption of INOmax therapy without prior dose reduction has been shown to cause hypotension or rebound pulmonary hypertension (a sudden increase in pressure in the lungs).

At the end of treatment, your doctor will gradually reduce the amount of INOmax administered to you or your child, allowing the pulmonary circulation to adjust to oxygen/air without the need for INOmax. This process may take one or two days before you or your child completely stop receiving INOmax.

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

4. Possible adverse effects

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

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

• Low platelet count.

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

• Hypotension, lung collapse, or difficulty breathing.

Adverse effects that may occur and are uncommon (affecting between 1 in 100 and 1 in 1,000 patients) are:

• Increased methemoglobin levels, resulting in reduced oxygen-carrying capacity.

Adverse effects observed but with unknown frequency (cannot be estimated from available data) are:

• Bradycardia (low heart rate) or excessively low blood oxygen levels (oxygen desaturation/hypoxemia) due to sudden interruption of treatment.
• Headache, dizziness, dry throat, or breathing difficulties following accidental exposure to nitric oxide in the environment (e.g., leaks from equipment or gas cylinders).

You should inform the medical staff immediately if you experience headache while being near your child during INOmax administration.

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

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 to the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of INOmax

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the label after CAD. The expiry date refers to the last day of the specified month.

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

• INOmax cylinders must be stored securely to prevent falls and potential damage.
• INOmax must be handled and administered only by personnel specifically trained in the use and handling of INOmax.

Regulations regarding the handling of pressurized gas cylinders must be strictly observed.

Storage must be supervised by hospital specialists. Store gas cylinders in well-ventilated rooms or ventilated shelters, protected from rain and direct sunlight.

Protect gas cylinders from impacts, falls, oxidation, 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, designated exclusively for the storage of medicinal gases. 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 in an upright position.

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

6. Contents of the pack and other information

Composition of INOmax

The active substance in INOmax is nitric oxide 400 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 1535 liters of gas at a pressure of 1 bar at 15°C.

The other ingredient is nitrogen.

Presentation and pack contents of INOmax

Medicinal compressed gas

Aluminum gas cylinder of 2 liters (identified with aquamarine-colored shoulder and white body), filled to a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve handwheel.

Aluminum gas cylinder of 2 liters (identified with aquamarine-colored shoulder and white body), filled to a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a valve handwheel fitted with an INOmeter device.

Aluminum gas cylinder of 10 liters (identified with aquamarine-colored shoulder and white body), filled to a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve handwheel.

Aluminum gas cylinder of 10 liters (identified with aquamarine-colored shoulder and white body), filled to a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a valve handwheel fitted with an INOmeter device.

INOmax is available 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: MM/YYYY

Other sources of information

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