Vasokinox

B. PATIENT LEAFLET

2018-03-EU-4947-BE/H/134/001/IB/026

Leaflet included in the packaging: information for the user

VasoKINOX, 450 ppm mol/mol, medical gas, compressed

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

• You should keep this leaflet, so that 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 the leaflet, you should tell your doctor.

Table of contents of the leaflet:

• 1. What is VasoKINOX, 450 ppm mol/mol - medical gas, compressed and what is it used for
• 2. Important information before using VasoKINOX, 450 ppm mol/mol, medical gas, compressed
• 3. How to use VasoKINOX, 450 ppm mol/mol, medical gas, compressed
• 4. Possible side effects
• 5. How to store VasoKINOX, 450 ppm mol/mol, medical gas, compressed
• 6. Contents of the packaging 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 newborns, infants and young children, children and adolescents from 0-17 years old.

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 (left-to-right or "bad" left-to-right shunt associated with the presence of a patent ductus arteriosus).

Warnings and precautions

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

Other medicines and VasoKINOX

• Caution should be exercised when administering VasoKINOX in combination with 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 (such as medicines containing alkyl nitrates and sulfonamides, prilocaine). They may increase methemoglobin levels in the blood.

and sulfonamides, prilocaine). They may increase methemoglobin levels in the blood.

• prostacyclin and its analogues
• You should inform your doctor about all medicines you have taken recently.
• It is up to the doctor to decide whether VasoKINOX and another medicine can be used at the same time.

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 either stop breastfeeding or stop VasoKINOX treatment
after considering the benefits of breastfeeding for the baby and the benefits of treatment for the woman.
Fertility:
No studies have been conducted on the effects 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.
• The 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 overdose:

The doctor will take appropriate measures.

Stopping VasoKINOX treatment:

At the end of treatment in the intensive care unit, the doctor will gradually reduce the dose of VasoKINOX (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.
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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 people) associated with VasoKINOX therapy include:

• Low platelet count.

Common side effects (affecting more than 1 in 100 people) associated with VasoKINOX therapy include:

• low blood pressure, decreased air volume in the lung or lung collapse.

Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people) include:

• increased methemoglobin levels (a form of hemoglobin that cannot carry oxygen), which reduces oxygen release to the body's tissues.

Rare side effects (frequency cannot be estimated from the 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 equipment leak or cylinder leak).

If you experience any side effects, including any possible side effects not listed in the 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 of the Office for Registration 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: [email protected]
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

• • The storage of VasoKINOX cylinders is ensured by the hospital.
• • Store in a place inaccessible and invisible to children.
• • Protect the cylinder from damage or falling and keep it away from flammable substances and materials and moisture.
• There are no special recommendations for the storage temperature of the medicine.
• • Securely fasten the cylinders to keep them in a vertical position and store them in a well-ventilated room.
• Do not use this medicine after the expiry date stated on the label.
• Do not dispose of the cylinder after it has been emptied. Empty cylinders will be collected by the supplier.

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6. Contents of the packaging and other information

What VasoKINOX contains

• The active substance is nitric oxide, with a concentration of 450 ppm mol/mol
• The other ingredient is nitrogen

What VasoKINOX looks like and what the pack contains

5-liter cylinder filled to 200 bar delivers 0.94 m
of gas at a pressure of 1 bar at a temperature of 15°C
11-liter cylinder filled to 200 bar delivers 2.1 m
of gas at a pressure of 1 bar at a temperature of 15°C
20-liter cylinder filled to 200 bar delivers 3.8 m
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 S antéINTERNATIONAL
75 Quai d’Orsay
75341 PARIS Cedex 07
FRANCE

Manufacturer

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

Marketing authorization number

21898

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

• Austria: VasoKINOX, 450 ppm mol/mol Gas zur medizinischen Anwendung, druckverdichtet
• 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
• Sweden: Vasokinox
• Netherlands: VasoKINOX

Prescription and dispensing conditions: 07/2018

Rpz - medicinal product dispensed with a doctor's prescription for restricted use.

Date of last revision of the leaflet:

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2018-03-EU-4947-BE/H/134/001/IB/026
The following information is intended exclusively for healthcare professionals:
In order to avoid accidents, you should carefully follow the following instructions:

• check if the device is ready for use before using it.
• securely fasten the cylinders using straps and hooks on the stand to prevent accidental falling
• never open the valve suddenly: the valve should be slowly opened in the opposite direction to the clockwise direction until the end, and then turned in the clockwise direction.
• never handle cylinders that do not have a protective cap and protective foil.
• You should use a specific connector ISO 5145 (2004): 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)
• when using the device for the first time, you should vent the pressure regulator/flow meter using the nitric oxide/nitrogen mixture
• do not attempt to repair a faulty valve
• do not tighten the pressure regulator/flow meter using wrenches, as this may cause the gasket to be crushed and the device to be damaged
• exhaled gases should be discharged outside (avoiding areas where they may accumulate). Before use, you should ensure that the room has an appropriate ventilation system to discharge gases in case of an emergency 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.
• 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) In order to meet the above recommendations, it is necessary to analyze the content of nitric oxide and nitrogen dioxide in the atmosphere.
• it is forbidden to install a permanent pipeline system supplying nitric oxide, including the station with reserve cylinders, stationary network, and inhalation sets.

2018-03-EU-4947-BE/H/134/001/IB/026