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VASOKINOX 450 PPM MOL/MOL MEDICINAL GAS COMPRESSED

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Vasokinox
450 ppm mol/mol,
medicinal gas, compressed.
Nitric oxide
Last revision : 03/2015

PACKAGE LEAFLET :
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

What is in this leaflet :

1. What Vasokinox 450 ppm mol/mol, medicinal gas, compressed is and what it is used for
2. What you need to know before you use Vasokinox 450 ppm mol/mol, medicinal gas, compressed
3. How to use Vasokinox 450 ppm mol/mol, medicinal gas, compressed
4. Possible side effects
5. How to store Vasokinox 450 ppm mol/mol, medicinal gas, compressed
6. Contents of the pack and other information

1. WHAT Vasokinox
USED FOR

IS AND WHAT

IT

IS

Vasokinox is a gas mixture, composed of nitric oxide and
nitrogen, used :
- to treat newborn infants with lung failure associated with an
increase in blood pressure in the pulmonary blood circulation
- to treat acute pulmonary hypertension (increase in blood
pressure in the pulmonary circulation), which can occur
during heart surgery in adults and newborn infants, infants
and toddlers, children and adolescents, ages 0-17 years.

They can increase the blood concentration of methaemoglobin.
- Prostacyclin and its analogues

• Tell your doctor if you are taking, have recently taken any other
medicines.
• It is the doctor who will decide whether it is necessary to treat you
with Vasokinox and with other medicines at the same time.

Pregnancy, breast-feeding and fertility :

Pregnancy :
The effect of the administration of Vasokinox in pregnant women is
unknown.
2. WHAT YOU NEED TO KNOW BEFORE YOU As a precautionary measure, it is preferable to avoid the use of
Vasokinox during pregnancy.
USE Vasokinox
Breast-feeding :
DO NOT USE Vasokinox :
It is unknown whether nitric oxide/metabolites are excreted in
human milk.
• If you suffer from hypersensitivity to nitric oxide,
A decision must be made whether to discontinue breast-feeding or to
• In newborns with certain heart defects, such as abnormal discontinue Vasokinox therapy taking into account the
circulation within the heart (right-to-left shunt, or with a benefit of breast feeding for the child and the benefit of therapy for
"malignant" left-right arterial canal).
the woman.
Fertility :
WARNINGS AND PRECAUTIONS
No fertility studies have been performed.
• Vasokinox treatment should not be stopped abruptly.
If you are pregnant or breast-feeding, think you may be pregnant or
• Blood samples are taken before treatment, then regularly during are planning to have a baby, ask your doctor for advice before
administration, to monitor certain parameters.
taking this medicine.
Other medicines and Vasokinox
3. HOW TO USE Vasokinox
• Vasokinox must be administered with caution if the medicines
mentioned hereafter are taken at the same time :
• Vasokinox is a medical gas only administered in hospitals by
healthcare professionals.
- “nitric oxide donors” (such as drugs containing sodium
nitroprusside and nitroglycerine). Their effect can be added to • Your doctor will determine the appropriate dose of Vasokinox
that of Vasokinox.
as well as the length of treatment, depending on your clinical
- Methaemoglobin-generating drugs (such as drugs containing
status and age.
alkylated nitrates and sulphamides, prilocaine).

• Vasokinox is administered by inhalation, by mechanical 5. HOW TO STORE Vasokinox
ventilation after dilution in an air/oxygen mixture for patients in
Intensive Care Units under respiratory assistance and also in the • The storage of Vasokinox cylinders is undertaken in hospital.
operating room.
• Keep this medicine out of the sight and reach of children.
• On contact with oxygen, nitric oxide can be converted into • The cylinder must be protected to avoid breakage or falling and
nitrogen dioxide, which is an irritant for the bronchial tubes. This
must be kept away from any inflammable or combustible materials
is why, throughout administration, the concentrations of inhaled
and from humidity, at a temperature of between -10°C and +50°C.
nitric oxide and nitrogen dioxide are continuously measured.
• The cylinders must be firmly secured to hold them in a vertical
• In certain clinical circumstances, administration of nitric oxide by
position and must be stored in a well-ventilated area.
ventilation through a mask is possible for a very short duration
• Do not use this medicine after the expiry date which is stated on
(5 to 10 mn).
the batch label.

If you have received more Vasokinox than you should have : • When the gas cylinder is empty, do not discard. Empty gas
Your doctor will take the appropriate measures.

Discontinuation of Vasokinox treatment :

cylinders will be collected by the supplier.

At the end of the treatment in intensive care, the doctor will gradually
INFORMATION
reduce the dose of Vasokinox administered (withdrawal stage), by
monitoring the change in your condition.
What Vasokinox contains
In fact, a sudden halt in the treatment after several hours of
• The active substance is nitric oxide, its dosage
administration may result in the deterioration of your clinical status :
450 ppm mol/mol
this is called the “rebound effect”.
• The other ingredient is nitrogen
If you have other questions on the use of this medicine, ask your
doctor for more information.
What Vasokinox looks like and contents of the pack

6. CONTENTS OF THE PACK AND OTHER

is

A 5-liter cylinder filled to 200 bar supplies 0.94 m3 of gas
at a pressure of 1 bar at 15°C.
Like all medicines, this medicine can cause side effects, although A 11-liter cylinder filled to 200 bar supplies 2.1 m3 of gas
not everybody gets them.
at a pressure of 1 bar at 15°C.
Side effects that are very commonly seen (affects more than 1 user A 20-liter cylinder filled to 200 bar supplies 3.8 m3 of gas
at a pressure of 1 bar at 15°C.
in 10) in association with Vasokinox therapy include:
• Low level of blood platelets.
Marketing Authorisation Holder and Manufacturer

4. POSSIBLE SIDE EFFECTS

Side effects that are commonly seen (affects more than 1 user in Marketing Authorisation Holder
100) in association with Vasokinox therapy include:
AIR LIQUIDE Santé INTERNATIONAL
• Low blood pressure, airless or collapsed lung.
75 Quai d’Orsay
Side effects that may be seen, but uncommonly (affects between 75341 PARIS Cedex 07 France
1 user in 100 and 1 user in 1000) are:
Manufacturer
• Increased amount of methaemoglobin (a form of haemoglobin AIR LIQUIDE Santé FRANCE
unable to carry oxygen) that reduces the release of oxygen to body “Les Petits Carreaux”
tissues.
2, avenue du Lys
Side effects that may be seen but the frequency is not known 94380 BONNEUIL-SUR-MARNE. France
(frequency cannot be estimated from the available data) are:
Marketing authorisation number :
• Bradycardia (low heart beat) or too low amount of oxygen in the
blood (oxygen desaturation/hypoxemia) due to sudden withdrawal PL number 27513/0002
of the treatment,
This medicinal product is authorised in the Member States of
• Headache, dizziness, dry throat or shortness of breath following the EEA under the following names :
accidental exposure to nitric oxide (e.g. leakage from equipment or - Austria : VasoKINOX 450 ppm mol/mol Gas zur medizinischen
cylinder).
Anwendung, druckverdichtet
You should directly inform the personnel if you experience - Belgium : VasoKINOX
headache while being in close proximity to your child or a patient - Denmark : Vasokinox
- Germany: VasoKINOX 450 ppm (mol/mol) Gas zur medizinischen
receiving Vasokinox.
Anwendung, druckverdichtet
Reporting of side effects
- Italy : VasoKINOX
If you get any side effects, talk to your doctor. This includes any
- Luxemburg : VasoKINOX
possible side effects not listed in this leaflet. You can also report side
- Poland : VasoKINOX
effects directly via the Yellow Card Scheme at :
- Portugal : VasoKINOX
www.mhra.gov.uk/yellowcard
- Spain : VasoKINOX
By reporting side effects you can help provide more information on
- United Kingdom : Vasokinox 450 ppm mol/mol, medicinal gas,
the safety of this medicine.
compressed
Conditions of prescription and issue :
On medical prescription

This leaflet was last revised in 03/2015.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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