Vasokinox 450 ppm mol/mol, medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VasoKINOX 450 ppm mol/mol, medicinal compressed 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, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, 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.

Contents of the leaflet

1. What VasoKINOX 450 ppm mol/mol, medicinal compressed gas is and what it is used for
2. What you need to know before using VasoKINOX 450 ppm mol/mol, medicinal compressed gas
3. How to use VasoKINOX 450 ppm mol/mol, medicinal compressed gas
4. Possible side effects
5. How to store VasoKINOX 450 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 elevated 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 and in neonates, infants and young children, children and adolescents, from 0 to 17 years of age

2. What you need to know before starting VasoKINOX

Do not use VasoKINOX:

• if you are hypersensitive to nitric oxide
• in neonates with certain heart problems, such as abnormal circulation within the heart (right-to-left shunt, or right-to-left "malignant" ductus arteriosus)

Warnings and precautions

Consult your doctor or nurse before starting treatment with 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 pulmonary fluid retention 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 using, have recently used, or might need to use any other medicines.

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

  • "Nitric oxide donors" (such as medications containing sodium nitroprusside and nitroglycerin). Their effect may add to that of VasoKINOX.
  • Medications that generate methemoglobin (such as medicines containing alkaloid nitrates and sulfamides, prilocaine). They may increase methemoglobin concentration in the blood.
  • Prostacyclin and its analogues

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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, it is preferable to avoid the use of VasoKINOX during pregnancy.

Breastfeeding:

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

A decision should 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 have been conducted on fertility.

3. How to use VasoKINOX

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, please 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, inhaled concentrations of nitric oxide and nitrogen dioxide are continuously monitored during administration.

• Under certain clinical circumstances, nitric oxide may be administered via ventilation using a mask for a very short period of time (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 may cause adverse effects, although not everyone experiences 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 infrequently (affect between 1 in 100 and 1 in 1000 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 abnormally low oxygen levels in the blood (oxygen desaturation/hypoxemia) due to sudden interruption 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 through 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 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 gas 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, properly secured, 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 450 ppm mol/mol
  • The other component is nitrogen

Presentation of the product and contents of the container

A 5-litre cylinder filled at 200 bar provides 0.94 m³ of gas at a pressure of 1 bar and 15°C.

An 11-litre cylinder filled at 200 bar provides 2.1 m³ of gas at a pressure of 1 bar and 15°C.

A 20-litre cylinder filled at 200 bar provides 3.8 m³ of gas at a pressure of 1 bar and 15°C.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AIR LIQUIDE S*anté* INTERNATIONAL
75 Quai d’Orsay
75007 PARIS Cedex 07
FRANCE

Manufacturer

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

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

• Austria: VasoKINOX 450 ppm mol/mol Gas zur medizinischen Anwendung, druckverdichet
• Belgium: VasoKINOX
• Denmark: VasoKINOX
• Germany: VasoKINOX 450 ppm (mol/mol), Gas zur medizinischen Anwendung, druckverdichtet
• Italy: VasoKINOX
• Luxembourg: VasoKINOX
• Norway: Vasokinox
• Poland: VasoKINOX
• Portugal: VasoKINOX
• Spain: VasoKINOX
• Switzerland: Vasokinox
• Netherlands: VasoKINOX

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

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

This information is intended for healthcare professionals only:

To prevent any accidents, 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.

• Use a pressure regulator capable of withstanding a pressure of at least 1.5 times the maximum operating pressure (200 bar) of the gas cylinder.

• At each new use, purge the pressure reducer/flowmeter using a nitric oxide/nitrogen mixture.

• Do not attempt to repair a defective valve.

• Do not tighten the pressure reducer/flowmeter using a wrench, as this may damage the seal and the administration 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 colourless and odourless, the use of a detection system is recommended in all rooms where the gas will be used or stored.

• European reference 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 nitric oxide pipeline system supplied by gas cylinders, fixed piping, and terminal units is prohibited.