VASOKINOX 800 PPM MOL/MOL MEDICINAL COMPRESSED GAS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VasoKINOX 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 or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What VasoKINOX 800 ppm mol/mol, medicinal compressed gas is and what it is used for
2. What you need to know before using VasoKINOX 800 ppm mol/mol, medicinal compressed gas
3. How to use VasoKINOX 800 ppm mol/mol, medicinal compressed gas
4. Possible side effects
5. Storage of VasoKINOX 800 ppm mol/mol medicinal compressed gas
6. Contents of the pack and other information

1. What VasoKINOX is and what it is used for

VasoKINOX is a gas mixture composed of nitric oxide and nitrogen, used for

the treatment of newborns with respiratory failure associated with increased blood pressure in the pulmonary circulation

the treatment of acute pulmonary hypertension (increased blood pressure in the pulmonary circulation) that may occur during cardiac surgery in adults, children, and adolescents from 0 to 17 years of age.

2. What you need to know before using VasoKINOX

Do not use VasoKINOX:

• if you are hypersensitive to nitric oxide
• in neonates with certain heart problems, such as abnormal blood flow within the heart (right-to-left shunt, or left-to-right arterial duct with "malignant" features)

Warnings and precautions

Consult your doctor or nurse before starting to use VasoKINOX.

• Treatment with VasoKINOX must not be stopped abruptly.
• Blood samples are taken before treatment and regularly during administration to monitor certain parameters.
• Cases of fluid accumulation in the lungs (pulmonary edema) have been reported with nitric oxide in patients who have a disease caused by a blocked or narrowed lung vein. If you (as a patient) or your child (as a patient) experiences shortness of breath or difficulty breathing, contact your doctor immediately.

Use of VasoKINOX with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

• VasoKINOX should be administered with caution if the following medicines are taken simultaneously:

• “Nitric oxide donors” (such as medications containing sodium nitroprusside and nitroglycerin). Their effect may add to that of VasoKINOX.

• Medications that may increase methemoglobin concentration in blood, such as those containing alkaloid nitrates, sulfonamides, and prilocaine.

• Prostacyclin and its analogs

  • Your doctor will decide whether it is necessary to treat you with VasoKINOX and other medications at the same time.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy:

The effect of administering VasoKINOX in pregnant women is unknown. As a precautionary measure, the use of VasoKINOX during pregnancy should be avoided.

Breastfeeding:

It is unknown whether nitric oxide/metabolites are excreted in human milk.

A decision must be made whether to discontinue breastfeeding or to discontinue therapy with VasoKINOX, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Fertility:

No studies on fertility have been conducted.

3. How to use VasoKINOX

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

• VasoKINOX is a medicinal gas administered only in hospitals by healthcare professionals.
• Your doctor will determine the appropriate dose of VasoKINOX, as well as the duration of treatment, depending on your clinical condition and age.
• VasoKINOX is administered by inhalation, via mechanical ventilation, after dilution in an air/oxygen mixture to patients in intensive care units requiring respiratory support, and also in the operating room.
• In contact with oxygen, nitric oxide may be converted into nitrogen dioxide, which irritates the bronchi. For this reason, during administration, inhaled concentrations of nitric oxide and nitrogen dioxide are continuously monitored.
• In certain clinical circumstances, nitric oxide may be administered via ventilation using a mask for a very brief period (5 to 10 minutes).

If you use more VasoKINOX than you should: Your doctor will take appropriate measures.

If you interrupt treatment with VasoKINOX:

At the end of treatment in intensive care, your doctor will gradually reduce the administered dose of VasoKINOX (weaning phase), monitoring any changes in your condition.

Indeed, abrupt interruption of treatment after several hours of administration may lead to worsening of the clinical condition: this is known as the "rebound effect".

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (affect more than 1 in 10 patients) associated with VasoKINOX therapies include:

. Low platelet count in blood

Common adverse effects (affect more than 1 in 100 patients) associated with VasoKINOX therapies include:

. Low blood pressure, lack of air, or pulmonary collapse.

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

. Increase in the amount of methemoglobin (a form of hemoglobin that cannot carry oxygen), which reduces the amount of oxygen delivered to tissues.

Adverse effects that may occur but whose frequency is unknown (frequency cannot be estimated from available data) are:

. Bradycardia (slow heart rate) or too low oxygen levels in the blood (oxygen desaturation/hypoxemia) due to abrupt discontinuation of treatment

. Headache, dizziness, dry throat, or difficulty breathing following accidental exposure to nitric oxide (e.g., equipment leak or cartridge)

You should inform the medical staff directly if you experience headache while being near your child during treatment with VasoKINOX.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VasoKINOX

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the label.

• This medicine does not require special temperature conditions for storage.

• Storage of VasoKINOX cylinders is carried out in the hospital.

• The cylinder must be protected to prevent breakage and falls, and must be kept away from any flammable or combustible materials and from moisture.

• Cylinders must be kept in an upright position, securely fastened, and stored in a well-ventilated area.

• When the gas cylinder is empty, do not dispose of it. Empty cylinders will be collected by the supplier.

6. Contents of the container and other information

Composition of VasoKINOX

• The active substance is nitric oxide; its concentration is 800 ppm mol/mol
• The other component is nitrogen

Appearance of the product and contents of the container

A 2-liter cylinder filled at 200 bar provides 0.4 m³ of gas at a pressure of 1 bar at 15°C.
An 11-liter cylinder filled at 200 bar provides 2.1 m³ of gas at a pressure of 1 bar at 15°C.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AIR LIQUIDE Santé INTERNATIONAL
75 Quai d’Orsay
75007 PARIS Cedex 07
FRANCE

Manufacturer

AIR LIQUIDE Santé FRANCE
“Les Petits Carreaux”
2, avenue du Lys
94380 BONNEUIL-SUR-MARNE
FRANCE

This medicinal product has been authorized in the EEA Member States under the following names:

• Austria: VasoKINOX
• Belgium: VasoKINOX
• Denmark: VasoKINOX
• Germany: VasoKINOX
• Italy: VasoKINOX
• Luxembourg: VasoKINOX
• Norway: Vasokinox
• Poland: VasoKINOX
• Portugal: VasoKINOX
• Spain: VasoKINOX
• Switzerland: Vasokinox
• Netherlands: VasoKINOX

Date of the most recent review of this summary: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es

This information is intended for healthcare professionals only:

To prevent any incidents, the following instructions must be strictly observed:

. Check that the equipment is in good condition before use

. Securely fasten cylinders using chains or hooks in the trolley to prevent accidental falls

. Never open a valve abruptly: open slowly and fully to the left, then turn the valve a quarter turn clockwise

. Do not handle a cylinder if the valve is not protected by a cap or protective device

. Use a specific ISO 5245 (2004) connector: No. 29 specific NO/N₂ (100 ppm <NO<1,000 ppm) W30x2 15.2-20.8 DR

. A pressure regulator must be used that supports a pressure of at least 1.5 times the maximum operating pressure (200 bar) of the gas cylinder

. For each new use, purge the pressure-reducing device/flowmeter using a nitric oxide/nitrogen mixture

. Do not attempt to repair a defective valve

. Do not tighten the pressure reducer/flowmeter with a wrench or pliers, as this may damage the seal and the delivery device

. Vent exhaled gases to the outside (avoiding areas where gases could accumulate). Before use, ensure that the room has adequate ventilation to remove gases in case of an accident or accidental leak

. Since nitric oxide is colorless and odorless, the use of a detection system is recommended in all rooms where the gas will be used or stored

. European regulatory agencies responsible for occupational safety and health recommend the following exposure limits for medical personnel over an 8-hour period:

• NO: 2 ppm (2.5 mg/m³)
• NO₂: 0.5 ppm (0.96 mg/m³)

To comply with the above recommendations, monitoring of nitric oxide and nitrogen dioxide levels in the atmosphere must be implemented.

. Installation of a piped nitric oxide system supplied by gas cylinders, fixed pipeline network, and terminal units is prohibited.