VASOKINOX 450 PPM Inhalation gas

Зміст інструкції

1. VasoKINOX 450 ppm mole/mole, medicinal gas, compressed
   1. What is VasoKINOX and what is it used for
   2. What you need to know before using VasoKINOX
   3. How to use VasoKINOX
   4. Possible side effects
   5. Contents of the pack and other information
2. VasoKINOX 800 ppm mole/mole, medicinal gas, compressed
   1. What is VasoKINOX and what is it used for
   2. What you need to know before using VasoKINOX
   3. How to use VasoKINOX
   4. Possible side effects
   5. Package contents and other information

VasoKINOX 450 ppm mole/mole, medicinal gas, compressed

Nitric oxide

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor.

Contents of this leaflet

• 1. What VasoKINOX is and what it is used for
• 2. What you need to know before using VasoKINOX
• 3. How to use VasoKINOX
• 4. Possible side effects
• 5. How to store VasoKINOX
• 6. Contents of the pack and other information

1. What is VasoKINOX and what is it used for

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

• treating newborns with pulmonary insufficiencyassociated with an increase in blood pressure in the pulmonary circulation;
• treating acute pulmonary hypertension( increased blood pressure in thepulmonary circulation) that may occur during a cardiac surgery inadults and newborns, infants, children and adolescents, aged between 0 and 17 years.

2. What you need to know before using VasoKINOX

Do not use VasoKINOX

• If you are hypersensitive to nitric oxide.
• In newborns with certain cardiac dysfunctions, such as abnormal blood circulation within the heart (right-to-left shunt or with malignant left-to-right arterial duct).

Warnings and precautions

• Treatment with VasoKINOX must not be stopped abruptly.
• Blood samples are taken before treatment, then regularly during administration to monitor certain parameters.

Other medicines and VasoKINOX

• VasoKINOX must be administered with caution when used simultaneously with the medicines indicated below:
• “Nitric oxide donors” (such as medicines containing sodium nitroprusside and nitroglycerin). Their effects may be additive to that of VasoKINOX.
• Medicines that can cause methemoglobinemia (such as medicines containing alkyl nitrates and sulfonamides, prilocaine). They may increase the blood concentration of methemoglobin.
• Prostacyclin and its analogues.
• Tell your doctor if you are taking, have recently taken, any other medicines.
• It is the doctor who decides whether it is necessary to be treated with VasoKINOX and with other medicines at the same time.

Pregnancy, breastfeeding and fertility
Pregnancy
The effect of administering VasoKINOX to pregnant women is not known.
As a precaution, it is preferable to avoid the use of VasoKINOX during pregnancy.
Breastfeeding
It is not known whether nitric oxide/metabolites are excreted in breast milk.
The decision must be made whether to discontinue breastfeeding or discontinue therapy with
VasoKINOX, taking into account the benefit of breastfeeding for the child and the benefit
of therapy for the woman.
Fertility
No studies on fertility have been conducted.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

3. How to use VasoKINOX

• VasoKINOX is a medicinal gas administered only in hospitals by healthcare professionals.
• The doctor will determine the appropriate dose ofVasoKINOX and the duration of treatment, based on your clinical condition and age.
• VasoKINOX is administered by inhalation, via mechanical ventilationfollowing dilution in a mixture of air/oxygen to patients undergoing assisted breathing who are hospitalised in intensive care units and in the operating room.
• Upon contact with oxygen, nitrous oxide can be converted into nitrogen dioxide, which is an irritant to the bronchi. For this reason, during administration, the concentrations of inhaled nitrous oxide and nitrogen dioxide are continuously monitored.
• In certain clinical circumstances, the administration of nitrous oxide via ventilation using a maskis possible for a very short duration (from 5 to 10 minutes).

If you take more VasoKINOX than you should
The doctor will take appropriate measures.

If you stop taking VasoKINOX
At the end of intensive care treatment, the doctor will gradually reduce the dose of VasoKINOX
administered (withdrawal phase) monitoring the change in conditions.
Indeed, a sudden interruption of treatment after many hours of administration may result
in worsening of your clinical condition: this is called a “rebound effect”.
For other questions about the use of the drug, ask your doctor for more information.
If you have any doubts about the use of VasoKINOX, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects observed very commonly (more than 1 in 10 patients) in relation to therapy with
VasoKINOX include:

• Low platelet count.

Side effects observable commonly (more than 1 in 100 patients) in relation to therapy with
VasoKINOX include:

• Low blood pressure, hypoxic or collapsed lung.

Side effects observable, but not commonly (between 1 in 100 and 1 in 1000 patients)
are:

• increased methemoglobin (a form of hemoglobin unable to carry oxygen) which reduces oxygen release to tissues. Side effects observable, but with unknown frequency (frequency cannot be defined based on available data) are:
• Bradycardia (slow heart rate) or too low oxygen levels in the blood (oxygen desaturation/hypoxia) due to sudden discontinuation of treatment.
• Headache, dizziness, dry throat or shortness of breath following accidental exposure to nitrous oxide (e.g. leaks from the device or cylinder). Inform staff directly if you experience headache when near your child or a patient undergoing therapy with VasoKINOX.

Reporting of side effects
If you get any side effects, talk to your doctor. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps to provide more information on the safety of this medicine.

5How to store VasoKINOX

• Storage of VasoKINOX cylinders is the responsibility of the hospital.
• Keep this medicine out of the sight and reach of children.
• The cylinder must be protected to prevent breakage or falling and must be kept away from flammable or combustible materials and humidity, at a temperature between -10°C and +50°C.
• The cylinders must be secured to be kept in a vertical position and must be stored in a well-ventilated area.
• Do not use this medicine after the expiry date which is stated on the label.
• When the gas cylinder is empty, do not throw it away. The empty gas cylinder will be collected by the supplier.

6. Contents of the pack and other information

What VasoKINOX contains

• The active ingredient is nitric oxide, its dosage is 450 ppm mole/mole.
• The excipient is nitrogen.

Description of the appearance of VasoKINOX and contents of the pack
A 5-liter cylinder filled to 200 bar delivers 0.94 m of gas at a pressure of 1 bar at 15°C.
An 11-liter cylinder filled to 200 bar delivers 2.1 m of gas at a pressure of 1 bar at 15°C.
A 20-liter cylinder filled to 200 bar delivers 3.8 m of gas at a pressure of 1 bar at 15°C.

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

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:

• 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

This leaflet was last updated on
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The following information is intended exclusively for healthcare professionals:
To avoid any accidents, strictly adhere to the instructions listed below:

• verify that the equipment is in good condition before use;
• securely fasten the cylinders with chains or locks in the rack to prevent any accidental falls;
• never open the valve abruptly: open it counterclockwise, slowly and completely, then turn the valve a quarter turn clockwise;
• do not handle a cylinder whose valve is missing the cap and protective cover;
• use a specific connector compliant with ISO 5145 (2004) standards: No. 29 specifically for NO/N (100 ppm < NO < 1000 ppm) W30x2 15.2-20.8 DR;
• a pressure regulator must be used that allows a pressure at least 1.5 times the maximum operating pressure (200 bar) of the gas cylinder;
• at each new use, purge the flowmeter/pressure reducer using the nitric oxide/nitrogen mixture;
• do not attempt to repair a faulty valve;
• do not tighten the pressure reducer/flowmeter using pliers, otherwise the gasket may break, damaging the delivery device;
• evacuate exhaled gases to the outside (avoiding areas where they could accumulate). Before use, check that the room has an adequate ventilation system for gases in case of accidents or accidental leaks;
• since nitric oxide is colorless and odorless, it is recommended to use a detection system in all rooms where it is used or stored;
• the American (NIOSH) and European agencies responsible for workplace safety and health recommend the following exposure limits for medical personnel:
• NO: 25 ppm for 8 hours (30 mg/m)
• NO₂: 2 ppm (4 mg/m) In order to comply with the above recommendations, an analysis of the concentrations of nitric oxide and nitrogen dioxide in the atmosphere is necessary. The construction of a piping system for the delivery of nitric oxide comprising a cylinder station (central plant), fixed network and terminal units at the patient's bed is prohibited.

VasoKINOX 800 ppm mole/mole, medicinal gas, compressed

Nitric oxide

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor.

Contents of this leaflet:

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

1. What is VasoKINOX and what is it used for

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

• treating newborns with pulmonary insufficiencyassociated with an increase in blood pressure in the pulmonary circulation
• treating acute pulmonary hypertension( increased blood pressure in thepulmonary circulation) which may occur during a cardiac surgery inadults, children and adolescents, aged between 0 and 17 years.

2. What you need to know before using VasoKINOX

Do not use VasoKINOX:

• If you are hypersensitive to nitric oxide
• In newborns with certain heart dysfunctions, such as abnormal blood flow within the heart (right-to-left shunt or with malignant left-to-right arterial duct).

Warnings and precautions:

• Treatment with VasoKINOX must not be stopped abruptly.
• Blood samples are taken before treatment, then regularly during administration to monitor certain parameters.

Other medicines and VasoKINOX:
Tell your doctor if you are taking, have recently taken or might take any other
medicine.

• VasoKINOX must be administered with caution when used simultaneously with the medicines indicated below:
• “Nitric oxide donors” (such as medicines containing sodium nitroprusside and nitroglycerin). Their effects may add up to that of VasoKINOX.
• Drugs that can cause methemoglobinemia (such as medicines containing alkyl nitrates and sulfonamides, prilocaine).
• Prostacyclin and its analogues.
• Tell your doctor if you are taking, have recently taken any other medicine.
• It is the doctor who decides whether it is necessary to be treated with VasoKINOX and with other drugs at the same time.

Pregnancy, breastfeeding and fertility
Pregnancy:
The effect of VasoKINOX administration on pregnant women is unknown.
As a precaution, it is preferable to avoid the use of VasoKINOX during pregnancy.
Breastfeeding:
It is not known whether nitric oxide/metabolites are excreted in breast milk.
A decision must be made whether to discontinue breastfeeding or discontinue therapy with
VasoKINOX taking into consideration the benefit of breastfeeding for the baby and the benefit
of therapy for the woman.
Fertility:
No studies on fertility have been conducted.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

3. How to use VasoKINOX

• VasoKINOX is a medicinal gas administered only in hospitals by healthcare professionals.
• The doctor will determine the appropriate dose ofVasoKINOX and the duration of treatment, based on your clinical condition and age.
• VasoKINOX is administered by inhalation, via mechanical ventilationfollowing dilution in a mixture of air/oxygen to patients undergoing assisted breathing who are hospitalized in intensive care units and in the operating room.
• Upon contact with oxygen, nitrous oxide can be converted into nitrogen dioxide, which is an irritant to the bronchi. For this reason, during administration, the concentrations of inhaled nitrous oxide and nitrogen dioxide are continuously monitored.
• In certain clinical circumstances, the administration of nitrous oxide via ventilation using a maskis possible for a very short duration (from 5 to 10 minutes).

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

If you stop taking VasoKINOX:
At the end of treatment in intensive care, the doctor will gradually reduce the dose of VasoKINOX
administered (withdrawal phase) monitoring the change in conditions.
In fact, a sudden interruption of treatment after many hours of administration can result
in worsening of your clinical condition: this is called a “rebound effect”.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects observed very commonly (more than 1 in 10 patients) in relation to therapy
with VasoKINOX include:

• Low platelet count.

Side effects observable commonly (more than 1 in 100 patients) in relation to therapy
with VasoKINOX include:

• Low blood pressure, hypoxic or collapsed lung.

Side effects observable, but not commonly (between 1 in 100 and 1 in 1000)
are:

• increased methemoglobin (a form of hemoglobin unable to carry oxygen) which reduces oxygen release to tissues.

Side effects observable, but with unknown frequency (frequency cannot be defined on the
basis of available data) are:

• Bradycardia (slow heart rate) or too low oxygen levels in the blood (oxygen desaturation/hypoxia) due to sudden discontinuation of treatment,
• Headache, dizziness, dry throat or shortness of breath following accidental exposure to nitrous oxide (e.g. leaks from the device or cylinder).

Inform staff directly if you notice a headache when near your child or a
patient undergoing therapy with VasoKINOX.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps to provide
more information on the safety of this medicine.

5How to store VasoKINOX

• The medicine does not require particular storage temperatures.
• Storage of VasoKINOX cylinders is the responsibility of the hospital.
• Keep this medicine out of the sight and reach of children.
• The cylinder must be protected to prevent breakage or falling and must be kept away from flammable or combustible materials and humidity,
• The cylinders must be secured so as to be kept in a vertical position and must be stored in a well-ventilated area.
• Do not use this medicine after the expiry date which is stated on the label.
• When the gas cylinder is empty, do not throw it away. The empty gas cylinder will be collected by the supplier.

6. Package contents and other information

What VasoKINOX contains:

• The active ingredient is nitric oxide, its dosage is 800 ppm mole/mole.
• The other component is nitrogen

Description of the appearance of VasoKINOX and package contents
A 2-liter cylinder filled to 200 bar delivers 0.4 m³ of gas at a pressure of 1 bar at 15°C.
An 11-liter cylinder filled to 200 bar delivers 2.1 m³ of gas at a pressure of 1 bar at 15°C.

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

This medicinal product is authorised in the Member States of the European Economic Area with the following denominations:

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

This leaflet was last updated on
---------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:
To avoid any accidents, strictly adhere to the instructions listed below:

• verify that the equipment is in good condition before use;
• secure the cylinders firmly with chains or locks in the rack to prevent accidental falls;
• never open the valve abruptly: open it counterclockwise, slowly and completely, then turn the valve a quarter turn clockwise
• do not handle a cylinder whose valve is missing the cap and protective cover;
• use a specific connector compliant with ISO 5145 (2004) standards: n°29 specific for NO/N (100 ppm < NO < 1000 ppm) W30x2 15.2-20.8 DR.
• a pressure regulator must be used that allows a pressure at least 1.5 times the maximum operating pressure (200 bar) of the gas cylinder
• with each new use, purge the flowmeter/pressure reducer using the nitric oxide/nitrogen mixture;
• do not attempt to repair a faulty valve;
• do not tighten the pressure reducer/flowmeter using pliers, otherwise the gasket may break, damaging the delivery device;
• evacuate exhaled gases outdoors (avoiding areas where they could accumulate). Before use, check that the room has an adequate ventilation system for gases in case of accidents or accidental leaks;
• since nitric oxide is colorless and odorless, it is recommended to use a detection system in all rooms where it is used or stored.
• The American (NIOSH) and European agencies responsible for workplace safety and health recommend the following exposure limits for medical personnel:
• NO: 25 ppm for 8 hours (30 mg/m³)
• NO₂: 2 ppm (4 mg/m³) In order to comply with the above recommendations, an analysis of the concentrations of nitric oxide and nitrogen dioxide in the atmosphere is necessary.
• The installation of a piping system for the delivery of nitric oxide comprising a cylinder supply station, a fixed network and terminal units is prohibited.