NOXAP 800 PPM MOL/MOL MEDICINAL GAS COMPRESSED
Active substance(s): NITRIC OXIDE
NOXAP 800 ppm mol/mol, medicinal gas, compressed
Active substance: Nitric Oxide
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, please ask your doctor or other healthcare professionals.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or other healthcare professionals. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
What NOXAP is and what is it used for
What do you need to know before you are given NOXAP
How NOXAP is given
Possible side effects
How to store NOXAP
Contents of the pack and other information
1. WHAT NOXAP IS AND WHAT IS IT IS USED FOR
NOXAP is a gas mixture for inhalation use.
NOXAP is a medicinal gas, compressed, consisting of a mixture of gases that contains 800 ppm mol/mol
of nitric oxide.
What are its uses?
NOXAP must be administered exclusively by healthcare professionals and it is only for strict hospital use
NOXAP is indicated in the following conditions:
1. In newborns with a shortage of oxygen in the blood (hypoxemic respiratory failure) related to
different causes. NOXAP improves oxygenation and reduces the need for extracorporeal circulation.
2. In pediatric and adult cardiac surgery patients with acute high blood pressure within the lung
(pulmonary hypertension). NOXAP reduces the high blood pressure in the lung and reduces the risk of
failure of the right heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NOXAP
Do not use NOXAP in the following situations :
- Newborns with known dependency to right-left blood shunt or suffer from a significant left-right
- Patients with congenital or acquired deficiency of methemoglobin reductase (MetHb reductase) or
glucose 6 phosphate dehydrogenase (G6PD).
Take special care with NOXAP:
- In patients with left ventricular dysfunction, NOXAP could lead to cardiac insufficiency and
- In patients with complex congenital heart defects.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Oxygen: In the presence of oxygen, nitric oxide oxidises rapidly producing substances that are toxic
for the lungs. To avoid this situation, continuous monitoring will be undertaken during NOXAP
NO donors: Cardiologic medicines such as Sodium Nitroprusside and Nitroglycerine, can have an
additive effect to NOXAP increasing the risk of developing methemoglobinemia.
Drugs that increase methemoglobin concentrations: When drugs such as alkyl nitrates, sulphonamides
and prilocaine are administrated along with nitric oxide there is increased risk of methemoglobinemia.
Synergic effects have been reported with the administration of vasoconstrictors (almitrine,
phenylephrine), prostacyclin and phosphodiesterase inhibitors, without increasing adverse effects.
Inhaled nitric oxide has been used concomitantly with tolazoline, dopamine, dobutamine,
norepinephrine, steroids and surfactants, with no drug interactions observed.
The doctor will decide if NOXAP can be used with other medications and will closely monitor your
Pregnancy and breast-feeding
NOXAP should not be used during pregnancy unless the clinical condition of the woman requires
treatment with NOXAP.
Harmful effects may be expected as methemoglobin is considered detrimental to the foetus and nitric
oxide has shown genotoxic potential by inducing structural alterations on DNA.
Breastfeeding should be discontinued during treatment with NOXAP.
Driving and using machines
Adverse effects on the ability to drive and use machines have not been communicated.
HOW NOXAP IS GIVEN
NOXAP must be administered exclusively by healthcare professionals and it is only for strict hospital use.
NOXAP is administered via inhalation which relies on a system that provides the lungs with the
prescribed nitric oxide concentration by diluting NOXAP in a mixture of oxygen and air.
Your doctor will determine the dosage and duration of your NOXAP treatment.
If you receive more NOXAP than you should the delivery system will activate a warning signal. Your
doctor will then reduce or stop the administration of NOXAP and subsequently will determine the most
suitable treatment to be followed.
If you stop receiving NOXAP
Your doctor will gradually reduce your NOXAP dosage towards the end of the treatment.
NOXAP treatment should not be abruptly interrupted but slowly reduced and so allow the lungs to adapt
to the normal oxygen concentration in the air.
If you have any further questions on the use of this product, ask your doctor or other health professionals.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will notice and closely monitor any side effects. It is not likely that you will experience these
side effects yourself.
Blood system disorders
elevated concentration of nitric oxide in the blood may run the risk of developing
methemogobinemia. In this case, blood oxygen transport capacity may be reduced. If this occurs, your
doctor will immediately reduce the nitric oxide dosage to allow the blood to achieve its normal
oxygen transport capacity. In pediatric patients and other with reduced levels of the enzyme,
methemoglobin reductase, this risk may increase. The formation of methemoglobin at a serum level of
>5% with inhaled nitric oxide at a concentrations of <20ppm is very rare (<1/10,000)
- Bleeding time: In a preclinical study has been found that inhaled nitric oxide increases the bleeding
time. However, in controlled clinical trials no significant differences have been found between the
control group and the treatment group regarding hemorrhagic complications.
General disorders and administration site conditions
- No response to the treatment can be observed in 30 to 45% of the cases.
- Significant elevations of NO2 levels at low therapeutic doses (<20 ppm) of inhaled NO, as well as
evidence of clinical toxicity by NO2 is a very rare (<1/10,000) complication.
- Abrupt interruption of the inhaled nitric oxide therapy, leads very frequently (>1/10) to rapid rebound
reactions presenting with intensified pulmonary vasoconstriction and hypoxemia. .
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or other healthcare professionals.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V*. By reporting side effects you can help provide more information on the safety of this
5. HOW TO STORE NOXAP
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the gas cylinder label after “EXP”.
All regulations concerning handling of pressurised gas cylinders must be followed.
Storage is supervised by the local specialists at the hospital. Gas cylinders are to be stored in wellventilated rooms or in ventilated sheds where they are protected from rain and direct sunlight.
Protect the gas cylinders from shocks, falls, oxidising and flammable materials, moisture, sources of heat
Storage in the pharmacy department
The gas cylinders should be kept in a place designated exclusively for medicinal gas storage that is well
ventilated, clean and under lock and key. This place should house a separate, special facility for the
storage of nitric oxide cylinders.
Storage in the medical department
The gas cylinders should be stored in a place with the appropriate equipment to ensure that it stays in a
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What NOXAP contains
NOXAP is a combination of gases.
The active substance is: nitric oxide 800 ppm (mol/mol)
The other ingredient is: nitrogen
What NOXAP looks like and contents of the pack
NOXAP is a medicinal gas, compressed.
NOXAPis stored in high pressure gas cylinders made out of aluminium or aluminium with an external
elastomers layer. The valves which close the gas cylinders are made out of stainless steel. The pack sizes
of the gas cylinders are 2L, 5L, 10L, 20L and 40L
NOXAP is filled as a gas in these gas cylinders to a pressure of 200 bar. Not all pack sizes may be
Litres Quantity of the
mixture 800 ppm NO/N2
m3 Quantity of the
mixture 800 ppm NO/N2
The colour coding of the cylinder is a turquoise blue shoulder on a white cylinder body.
Marketing Authorisation Holder and Manufacturer
Air Products Plc
2 Millennium Gate
S.E. de Carburos Metálicos, S.A.
Polígon Nord-Est, C-35 km 59
08470 Sant Celoni (Barcelona)
This medicinal product is authorised in the Member States of the EEA under the following names :
Belgium: NOXAP 800 ppm mol/mol, medicinaal gas, samengeperst
The Netherlands : NOXAP 800 ppm mol/mol, medicinaal gas, samengeperst
France : NOXAP 800 ppm mol/mol, gaz médicinal comprimé
Portugal: NOXAP 800 ppm mol/mol, gás medicinal comprimido
Czech Republic : NOXAP 800 ppm mol/mol, medicinální plyn, stlačený
Germany : NOXAP 800 ppm Mol/Mol Gas zur medizinischen Anwendung, druckverdichtet
United Kingdom: NOXAP 800 ppm mol/mol, medicinal gas, compressed
Spain : NOXAP 800 ppm moles/mole, gas medicinal comprimido
Poland: NOXAP 800 ppm mol/mol, gaz medyczny, sprężony
Italy: NOXAP 800 ppm mol/mol, gas medicinale compresso
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