Vasokinox 450 ppm mol/mol, medicinal gas, compressed Nitric oxide

Last revision : 03/2015

package leaflet : information for the user

1.    WHAT Vasokinox IS AND WHAT IT IS USED FOR

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.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE Vasokinox

DO NOT USE Vasokinox :

•    If you suffer from hypersensitivity to nitric oxide,

•    In newborns with certain heart defects, such as abnormal circulation within the heart (right-to-left shunt, or with a "malignant" left-right arterial canal).

WARNINGS AND PRECAUTIONS

•    Vasokinox treatment should 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 if the medicines mentioned hereafter are taken at the same time :

-    “nitric oxide donors” (such as drugs containing sodium nitroprusside and nitroglycerine). Their effect can be added to that of Vasokinox.

-    Methaemoglobin-generating drugs (such as drugs containing alkylated nitrates and sulphamides, prilocaine).

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.

As a precautionary measure, it is preferable to avoid the use of Vasokinox during pregnancy.

Breast-feeding :

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

A decision must be made whether to discontinue breast-feeding or to discontinue Vasokinox therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility :

No fertility studies have been performed.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

3. HOW TO USE Vasokinox

•    Vasokinox is a medical gas only administered in hospitals by healthcare professionals.

•    Your doctor will determine the appropriate dose of Vasokinox as well as the length of treatment, depending on your clinical status and age.

•    Vasokinox is administered by inhalation, by mechanical ventilation after dilution in an air/oxygen mixture for patients in Intensive Care Units under respiratory assistance and also in the operating room.

•    On contact with oxygen, nitric oxide can be converted into nitrogen dioxide, which is an irritant for the bronchial tubes. This is why, throughout administration, the concentrations of inhaled nitric oxide and nitrogen dioxide are continuously measured.

•    In certain clinical circumstances, administration of nitric oxide by ventilation through a mask is possible for a very short duration (5 to 10 mn).

If you have received more Vasokinox than you should have :

Your doctor will take the appropriate measures.

Discontinuation of Vasokinox treatment :

At the end of the treatment in intensive care, the doctor will gradually reduce the dose of Vasokinox administered (withdrawal stage), by monitoring the change in your condition.

In fact, a sudden halt in the treatment after several hours of administration may result in the deterioration of your clinical status : this is called the “rebound effect”.

If you have other questions on the use of this medicine, ask your doctor for more information.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that are very commonly seen (affects more than 1 user in 10) in association with Vasokinox therapy include:

•    Low level of blood platelets.

Side effects that are commonly seen (affects more than 1 user in 100) in association with Vasokinox therapy include:

•    Low blood pressure, airless or collapsed lung.

Side effects that may be seen, but uncommonly (affects between 1 user in 100 and 1 user in 1000) are:

•    Increased amount of methaemoglobin (a form of haemoglobin unable to carry oxygen) that reduces the release of oxygen to body tissues.

Side effects that may be seen but the frequency is not known

(frequency cannot be estimated from the available data) are:

•    Bradycardia (low heart beat) or too low amount of oxygen in the blood (oxygen desaturation/hypoxemia) due to sudden withdrawal of the treatment,

•    Headache, dizziness, dry throat or shortness of breath following accidental exposure to nitric oxide (e.g. leakage from equipment or cylinder).

You should directly inform the personnel if you experience headache while being in close proximity to your child or a patient receiving Vasokinox.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at : www.mhra.gov.uk/yellowcard

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 undertaken in hospital.

•    Keep this medicine out of the sight and reach of children.

•    The cylinder must be protected to avoid breakage or falling and must be kept away from any inflammable or combustible materials and from humidity, at a temperature of between -10°C and +50°C.

•    The cylinders must be firmly secured to hold them 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 batch label.

•    When the gas cylinder is empty, do not discard. Empty gas cylinders will be collected by the supplier.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vasokinox contains

•    The active substance is nitric oxide, its dosage is 450 ppm mol/mol

•    The other ingredient is nitrogen

What Vasokinox looks like and contents of the pack

A 5-liter cylinder filled to 200 bar supplies 0.94 m³ of gas at a pressure of 1 bar at 15°C.

A 11-liter cylinder filled to 200 bar supplies 2.1 m³ of gas at a pressure of 1 bar at 15°C.

A 20-liter cylinder filled to 200 bar supplies 3.8 m³ of gas at a pressure of 1 bar at 15°C.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

AIR LIQUIDE Sante INTERNATIONAL

75 Quai d’Orsay

75341 PARIS Cedex 07 France

Manufacturer

AIR LIQUIDE Sante FRANCE

“Les Petits Carreaux”

2, avenue du Lys

94380 BONNEUIL-SUR-MARNE. France Marketing authorisation number :

PL number 27513/0002

This medicinal product is authorised in the Member States of the EEA 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

-    Luxemburg : VasoKINOX

-    Poland : VasoKINOX

-    Portugal : VasoKINOX

-    Spain : VasoKINOX

-    United Kingdom : Vasokinox 450 ppm mol/mol, medicinal gas, compressed

Conditions of prescription and issue :

On medical prescription

This leaflet was last revised in 03/2015.