Vasokinox

B. PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

VasoKINOX, 800 ppm mol/mol, medical gas, compressed

Nitric oxide

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the user.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor.

Table of contents of the leaflet:

• 1. What is VasoKINOX, 800 ppm mol/mol - medical gas, compressed, and what is it used for
• 2. Important information before using VasoKINOX, 800 ppm mol/mol, medical gas, compressed
• 3. How to use VasoKINOX, 800 ppm mol/mol, medical gas, compressed
• 4. Possible side effects
• 5. How to store VasoKINOX, 800 ppm mol/mol, medical gas, compressed
• 6. Package contents and other information

1. What is VasoKINOX and what is it used for

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

• • to treat newborns with respiratory failureassociated with increased pressure in the pulmonary circulation
• • in the treatment of acute pulmonary hypertension(increase in blood pressure in the pulmonary circulation), which may occur during heart surgery in adults and children and adolescents aged 0-17 years.

2. Important information before using VasoKINOX

VasoKINOX should not be used:

• in case of hypersensitivity to nitric oxide,
• in newborns with certain heart defects, such as abnormal circulation in the heart (right-to-left or "malignant" left-to-right shunt associated with the presence of a patent ductus arteriosus).

Warnings and precautions

• VasoKINOX treatment should not be stopped abruptly.
• Blood samples will be taken before starting treatment, and then regularly during administration of the medicine to monitor certain parameters.

Other medicines and VasoKINOX

You should tell your doctor about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take.

• You should be cautious when administering VasoKINOX in case of concomitant use of the following medicines:
• "nitric oxide donors" (such as medicines containing sodium nitroprusside and nitroglycerin). Their effect may be additive to the effect of VasoKINOX.
• medicines that increase methemoglobin levels in the blood, such as medicines containing alkyl nitrates and sulfonamides, prilocaine.
• prostacyclin and its analogs
• You should inform your doctor about all medicines you have taken recently.
• The decision to treat with VasoKINOX and another medicine at the same time will be made by your doctor.

Pregnancy, breastfeeding, and fertility:

Pregnancy:
The effect of using VasoKINOX in pregnant women is unknown.
As a precautionary measure, it is recommended to avoid using VasoKINOX during pregnancy.
Breastfeeding:
It is not known whether nitric oxide/metabolites pass into human milk.
A decision should be made to stop breastfeeding or stop VasoKINOX treatment
after considering the benefits of breastfeeding for the child and the benefits of treatment for the woman.
Fertility:
No studies have been conducted on the effect on fertility.
In case of pregnancy or breastfeeding, or if you are planning to become pregnant, you should consult your doctor before using this medicine.

3. How to use VasoKINOX

• VasoKINOX is a medical gas administered exclusively in hospitals by medical personnel.
• Your doctor will determine the appropriate dose of VasoKINOX, as well as the duration of treatment, depending on the patient's clinical condition and age.
• VasoKINOX is administered by inhalation using mechanical ventilationafter dilution of the air/oxygen mixture to patients in intensive care units as part of assisted breathing, as well as in the operating room.
• After coming into contact with oxygen, nitric oxide can be converted into nitrogen dioxide, which has an irritating effect on the bronchi. Therefore, during therapy, the concentrations of inhaled nitric oxide and nitrogen dioxide are constantly measured.
• In some clinical situations, administration of nitric oxide using a maskis possible for a very short period (5 to 10 minutes).

In case of receiving more VasoKINOX than prescribed:

Your doctor will take appropriate measures.

Stopping VasoKINOX treatment:

At the end of treatment in the intensive care unit, your doctor will gradually reduce the dose of VasoKINOX administered (weaning phase) while monitoring changes in the patient's condition.
In fact, sudden discontinuation of therapy after several hours of administration may affect the worsening of the patient's clinical condition, which is called the "rebound effect".
If you have any further questions about using this medicine, you should ask your doctor for additional information.

4. Possible side effects

Like all medicines, VasoKINOX can cause side effects, although not everybody gets them.
Very common side effects (affecting more than 1 in 10 patients) associated with VasoKINOX therapy include:

• Low platelet count. Common side effects (affecting more than 1 in 100 patients) associated with VasoKINOX therapy include:
• low blood pressure, decreased lung volume or lung collapse. Uncommon side effects (affecting more than 1 in 1000 patients and less than 1 in 100) include:
• increased methemoglobin levels (a form of hemoglobin unable to carry oxygen), which reduces oxygen release to body tissues. Side effects that may occur, but whose frequency is unknown (cannot be estimated from available data), include:
• bradycardia (slow heart rate) or low oxygen levels in the blood (hypoxemia) due to sudden discontinuation of treatment,
• headache, dizziness, dry throat, and shortness of breath following accidental exposure to nitric oxide (e.g., due to leakage from equipment or cylinders). If you experience headache while near a child or patient receiving VasoKINOX, you should immediately inform the medical staff.

Reporting side effects

If you experience any side effects, including any possible side effects not listed
in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects
can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301
fax: +48 22 49 21 309 e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VasoKINOX

• Storage of VasoKINOX cylinders is ensured by the hospital.
• Keep out of the reach and sight of children.
• Protect the cylinder from damage or falling and keep it away from flammable substances and materials, as well as moisture. There are no special recommendations for storage temperature.
• Securely fasten the cylinders to keep them in a vertical position and store them in a well-ventilated area.
• Do not use this medicine after the expiry date stated on the label.
• Do not dispose of the cylinder after it is empty. Empty cylinders will be collected by the supplier.

6. Package contents and other information

What VasoKINOX contains

• The active substance is nitric oxide, with a dose of 800 ppm mol/mol
• The other ingredient is nitrogen

What VasoKINOX looks like and what the package contains

Cylinder with a capacity of 2 L or 11 L.
The cylinder is made of aluminum alloy, equipped with a residual pressure valve made of stainless steel with a specific connector for the socket. The cylinder body is white, and the Turkish cap is blue.
A 2-liter cylinder filled to 200 bar delivers 0.4 mg of gas at a pressure of 1 bar at a temperature of 15°C
An 11-liter cylinder filled to 200 bar delivers 2.1 mg of gas at a pressure of 1 bar at a temperature of 15°C
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Air Liquide Santé International
75 Quai D’orsay
75007 Paris
France

Manufacturer

Air Liquide Santé France
“Les Petits Carreaux”
2, Avenue Du Lys
94380 Bonneuil-Sur-Marne
France

Marketing authorization number

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

Prescription and dispensing conditions:

RPz - Medicinal product available on prescription.

Date of last revision of the leaflet:

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The following information is intended for healthcare professionals only:
To avoid accidents, you should strictly follow the following instructions:

• check if the device is ready for use before using it.
• securely fasten the cylinders using chains and hooks on the stand to prevent accidental falling
• never open the valve abruptly: the valve should be slowly opened in the direction opposite to the direction of the clock hands until the end, and then turned a quarter turn clockwise.
• never handle a cylinder whose valve is not protected by a protective cap and foil.
• You should use a specific ISO 5145 (2004) connector: No. 29 intended for NO/N2 (100 ppm
• you should use a pressure regulator that provides a pressure of at least 1.5 times the maximum working pressure of the gas cylinder (200 bar)
• at each new use, you should purge the pressure regulator/flowmeter using a nitric oxide/nitrogen mixture
• do not attempt to repair a faulty valve
• do not tighten the pressure regulator/flowmeter using wrenches, as this may cause the gasket to be crushed and the administration device to be damaged.
• ventilate the exhaled gases outside (avoiding areas where they may accumulate). Before use, ensure that the room has a suitable ventilation system to vent gases in case of an accident or accidental leak.
• since nitric oxide is colorless and odorless, it is recommended to use a detection system in all rooms where it will be used or stored.
• The American (NIOSH) and European authorities responsible for occupational safety and health recommend the following exposure limits:
• NO: 25 ppm over 8 hours (30 mg/m3)
• NO2: 2 ppm (4 mg/m3) To meet these recommendations, it is necessary to analyze the content of nitric oxide and nitrogen dioxide in the atmosphere.
• It is forbidden to install a fixed pipeline system supplying nitric oxide, including a station with reserve cylinders, a stationary network, and inhalation units.