Noxap 800 Ppm Mol/Mol Medicinal Gas Compressed
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOXAP 800 ppm mol/mol, medicinal gas, compressed
Active substance: Nitric Oxide
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other healthcare professionals.
In this leaflet :
1. What NOXAP is and what is it used for
2. Before you are given NOXAP
3. How N OXAP is given
4. Possible side effects
5. Storing N OXAP
6. Further 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. BEFORE YOU ARE GIVEN NOXAP
Do not use NOXAP in the following situations :
- Newborns with known de pendency to right-left blood shunt or suffer from a significant left-right shunt.
- Patients with congenital o r acquired deficiency of methemoglobin reductase (MetHb reductase) o r glucose 6 phosphate dehydrogenase (G6PD).
Take special care with NOXAP:
- In patients with left ventricular dysfunction, NOXAP could lead to cardiac insufficiency and pulmonary oedema.
- 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 treatment.
- 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 treatment.
Pregnancy and breast-feeding
NOXAP should not be used during pregnancy unless the clinical condition of the woman requires treatment with NOXAP.
Harmful effects m ay be e xpected 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.
3. HOW NOXAP IS GIVEN
NOXAP must be administered exclusively by healthcare professionals and it is only for strict hospital use. NOXAP is a dministered 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, NOXAP 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 others 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.
5. STORING NOXAP
Keep out of the reach and sight of children.
Do not use NOXAP 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 well-ventilated 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 or ignition.
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 vertical position.
6. FURTHER INFORMATION What NOXAPcontains
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 2 L, 5L, 10L, 20L and 40L
NOXAP is filled as a gas in these gas cylinders to a pressure of 200 bar. Not all pack si zes may be marketed.
|
Pack sizes litres) |
Filling Pressure (bar) |
Litres Quantity of the mixture 800ppm NO/N2 |
m3 Quantity of the mixture 800 ppm NO/N2 |
|
2 |
200 |
400 |
0.400 |
|
5 |
200 |
945 |
0.945 |
|
10 |
200 |
1890 |
1.890 |
|
20 |
200 |
3780 |
3.780 |
|
40 |
200 |
7560 |
7.560 |
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 Millenium Gate
Westmere Drive Crewe Cheshire CW 1 6AP United Kingdom
Manufacturer:
S.E. de CARBUROS METALICOS S.A.
C/ Aragon 300, 08009-Barcelona Spain
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 medicinal comprime
Portugal: NOXAP 800 ppm mol/mol, gas medicinal comprimido
Czech Republic : NOXAP 800 ppm mol/mol, medicinalm plyn, stlaceny
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
This leaflet was last approved in March 2013
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