INOmax 800 ppm mol/mol inhalation gas

INOmax contains nitric oxide, a gas used for the treatment of
- newborn babies with lung failure associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure. When inhaled, this gas mixture can improve the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches your baby?s blood.

newborn babies, babies, children, teenagers 0-17 years and adults with high blood pressure in the lungs, connected with heart surgery. This gas mixture can improve heart function and increase the flow of blood through the lungs.

Do not use INOmax

• If you (as the patient) or your child (as the patient) are allergic (hypersensitive) to nitric oxide or any other ingredients of INOmax. (see section 6 ?further information? where the full list of ingredients is provided).
• If you have been told that you (as the patient) or your child (as the patient) have an abnormal circulation within the heart.

Take special care with INOmax

Inhaled nitric oxide may not always be effective and thus other therapies may be considered necessary for you or your child.

Inhaled nitric oxide may influence the oxygen carrying capacity of the blood. This will be monitored by blood samples and if required the dose of inhaled nitric oxide must be reduced.

Nitric oxide may react with oxygen forming nitrogen dioxide that may cause airway irritation. Your or your child?s doctor will undertake monitoring of nitrogen dioxide and in case of elevated values the INOmax therapy will be adjusted, decreased accordingly.

Inhaled nitric oxide may have a mild but influence on the platelets (components that help the blood to clot) of you or your child and any signs of bleeding and or haematoma should be observed. If you see any signs or symptoms that may be associated to bleeding you should directly inform the doctor.

No effect of inhaled nitric has been documented in newborn babies with a malformation where the diaphragm is not fully complete, so called ?congenital diaphragmatic hernia?.

In newborn babies with special malformations of the heart, ?what doctors calls congenital heart defects? inhaled nitric oxide may cause a worsening of the circulation.

Children

INOmax should not be used in preterm baby < 34 weeks of gestational age.

Using other medicines

The doctor will decide when to treat you or your child with INOmax and with other medicines, and will carefully supervise the treatment.

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

Some medicines can affect the ability of blood to carry oxygen. These include prilocaine (a local anaestheticused for pain relief in association to minor painful procedures e.g. suturing, and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain). Your doctor will take care to check that the blood can carry enough oxygen when you are taking these medicines.

Pregnancy and breastfeeding

INOmax is not recommended for use during pregnancy and breastfeeding. Tell your doctor before treatment with INOmax if you are pregnant, think you could be pregnant or are breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Your doctor will decide the correct dose of INOmax and will administer INOmax to you or your child?s lungs through a system designed for delivering this gas. This delivery system will ensure that the correct amount of nitric oxide is delivered by diluting INOmax with an oxygen/air mixture immediately before giving it to you.

For you or your child?s safety, the delivery systems intended for administration of INOmax are fitted with devices that constantly 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 decide how long you or your child should be treated with INOmax.

INOmax is given in dose of 10 to 20 ppm, (maximal dose 20 ppm in children and 40 ppm in adults) part per million of the gas that you or your child inhale. The lowest effective dose will be sought. Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs. In children and adults with high blood pressure in the lungs, connected with heart surgery, INOmax is usually given for 24-48 hours. However, therapy with INOmax may last longer.

If you or your child receive more INOmax than you should

Too much of inhaled nitric oxide may influence the oxygen carrying capacity of the blood. This will be monitored by blood samples and if required the INOmax dose will be decreased and the administration of medicines such as vitamin C, methylene blue, or eventually blood transfusion, in order to improve the oxygen carrying capacity, may be considered.

Stopping treatment with INOmax

Treatment with INOmax should not be stopped suddenly. Low blood pressure or a rebound increase in pressure in the lungs has been known to occur if treatment with INOmax is stopped suddenly without first lowering the dose.

At the end of treatment, the doctor will slowly lower the amount of INOmax being given to you or your child, so that the circulation in the lungs is able to adjust to oxygen/air without INOmax. Thus it may take a day or two before you or your child is off INOmax therapy.

If you have any other questions on the use of this medicine, ask your doctor.

Like all medicines, INOmax can cause side effects, although not everybody gets them. The doctor will examine you or your child closely for all side effects.

Side effects that are very commonly seen (affects more than 1 user in 10) in association with INOmax therapy include:
- Low platelet count, abnormally low potassium concentration in the blood (hypokalemia), low blood pressure, airless or collapsed lung, abnormally high amounts of bile pigment (bilirubin) in the blood.

Side effects that may be seen but the frequency is not known (frequency cannot be estimated from the available data) are:
- Rebound high blood pressure in the lungs (increase in pulmonary artery pressure), and too low amount of oxygen in the blood (oxygen desaturation/hypoxemia) due to sudden withdrawal of the treatment, increase in methemoglobin, thus reduced oxygen carrying capacity.

Accidental ambient air exposure to nitric oxide, e.g. leakage from equipment or cylinder may cause headache.

You should directly inform the personnel if you experience headache while being in close proximity to your child receiving INOmax.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, even after you or your child leave the hospital, please tell your doctor.

Keep out of the reach and sight of children

Do not use INOmax after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

INOmax therapy should only be used and handled by hospital personnel.
- INOmax cylinders should be stored secured in order to avoid falling and thus potentially causing harm.

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

All regulations concerning handling of pressurised gas cylinders must be followed. Storage is supervised by the specialists at the hospital. Gas cylinders are to be stored in well-ventilated rooms or in ventilated sheds where they are protected from rain and direct sunlight.

Protect the gas cylinders from shocks, falls, oxidising and flammable materials, moisture, sources of heat or ignition.

Storage in the pharmacy department

The gas cylinders should be stored in an airy, clean and locked place, for storage of medicinal gas only. Inside this place, a separate premise should be dedicated to the storage of nitric oxide gas cylinders.

Storage in the medical department

The gas cylinder should be put in an equipped site with appropriate material in order to hold the cylinder vertically.

When the gas cylinder is empty, do not discard. Empty gas cylinders will be collected by the supplier.

What INOmax contains

The active substance in INOmax is nitric oxide 800 ppm mol/mol. A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15 oC. A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15 oC.

The other ingredient is nitrogen.

What INOmax looks like and contents of the pack

Inhalation gas

A 2 litre and 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection.

INOmax is available in 2 litre and 10 litre aluminium gas cylinder.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

INO Therapeutics AB
SE-181 81 Lidingo
Sweden

Manufacturer

Linde France
Zone Industrielle de Limay Porcheville
2 rue Gustave Eiffel - 3 avenue Ozanne
78440 Gargenville
France

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