NOXAP 200 PPM MOL/MOL, COMPRESSED MEDICAL GAS
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How to use NOXAP 200 PPM MOL/MOL, COMPRESSED MEDICAL GAS
Introduction
Package Leaflet: Information for the User
NOXAP 200 ppm mol/mol, medicinal gas, compressed
Nitric oxide
Read this package leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this package leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
Contents of the package leaflet
- What is NOXAP and what is it used for
- What you need to know before you start using NOXAP
- How to use NOXAP
- Possible side effects
- Storage of NOXAP
- Package contents and further information
1. What is NOXAP and what is it used for
NOXAP is a mixture of gases for inhalation use.
NOXAP is a medicinal gas, compressed, consisting of a mixture of gases containing 200 ppm mol/mol of nitric oxide.
What are its uses?
NOXAP should be administered exclusively by healthcare professionals and is only for use in hospitals. NOXAP is indicated in the following cases:
In newborns with lack of oxygen in the blood (hypoxemic respiratory failure) related to different causes.
NOXAP improves oxygenation and reduces the need for circulation
In pediatric and adult patients undergoing cardiac surgery with acute high blood pressure in the lungs(pulmonary hypertension). NOXAP reduces pulmonary hypertension and the risk of right heart failure.
2. What you need to know before you start using NOXAP
Do not use NOXAP in the following cases:
- Newborns with proven dependence on right-to-left shunt or those with significant left-to-right shunt.
- Patients with congenital or acquired deficiency of methemoglobin reductase (MetHb reductase) or glucose-6-phosphate dehydrogenase (G6PD).
Be cautious when using NOXAP:
- In patients with left ventricular dysfunction, NOXAP may cause heart failure and pulmonary edema.
- In patients with complex congenital heart defects.
Use of other medicines
Tell your doctor if you are using or have recently used other medicines, including those obtained without a prescription.
Oxygen:In the presence of oxygen, nitric oxide is rapidly oxidized, producing substances that are toxic to the lungs. To avoid this situation, continuous monitoring should be performed during treatment with NOXAP.
NO donors:Cardiovascular medications such as sodium nitroprusside and nitroglycerin may have an additive effect to that of NOXAP, increasing the risk of methemoglobinemia.
Drugs that increase methemoglobin concentrations: When drugs such as alkyl nitrates, sulfonamides, and prilocaine are administered with nitric oxide, there is an increased risk of methemoglobinemia.
Synergistic effects have been reported with the administration of vasoconstrictors (almitrine, phenylephrine), prostacyclin, and phosphodiesterase inhibitors, without increasing adverse reactions.
Inhaled nitric oxide has been used at the same time as tolazoline, dopamine, dobutamine, norepinephrine, steroids, and surfactants, without any observed interactions.
Your doctor will decide if NOXAP can be used with other medicines and will closely monitor your treatment.
Pregnancy and breastfeeding
NOXAP should not be used during pregnancy unless the woman's clinical condition requires treatment with NOXAP.
Harmful effects may be expected since methemoglobin is considered harmful to the fetus and nitric oxide has demonstrated genotoxic potential through the induction of structural alterations in DNA.
Breastfeeding should be interrupted during treatment with NOXAP.
Driving and using machines
No studies have been reported on the ability to drive and use machines.
3. How to take NOXAP
NOXAP should be administered exclusively by healthcare professionals and is only for use in hospitals.
NOXAP is administered by inhalation through a system that delivers the prescribed concentration of nitric oxide to the lungs, by diluting NOXAP in a mixture of oxygen and air.
Your doctor will determine the dosage and duration of your treatment with NOXAP.
If you take more NOXAP than you should,the administration system will activate a warning signal. Then, your doctor will decrease or stop the administration of NOXAP and subsequently determine the most appropriate treatment to be followed.
If you stop treatment with NOXAP
Your doctor will gradually decrease the dosage of NOXAP until the end of treatment.
Treatment with NOXAP should not be stopped abruptly, but rather reduced slowly to allow the lungs to adapt to the normal oxygen concentration in the air.
If you have any further questions about the use of this product, ask your doctor or another healthcare professional.
4. Possible side effects
Like all medicines, NOXAP can cause side effects, although not everybody gets them.
Your doctor will observe and closely monitor any side effects. It is unlikely that you will experience these side effects.
Blood and lymphatic system disorders
- An increase in the concentration of nitric oxide in the blood may carry the risk of methemoglobinemia. In this case, the ability of the blood to transport oxygen may decrease. If this occurs, your doctor will immediately decrease the dosage of nitric oxide to allow the blood to reach its normal oxygen-carrying capacity. In pediatric patients and others with reduced levels of the enzyme methemoglobin reductase, this risk may increase. The formation of methemoglobin with a serum level of > 5% with inhaled nitric oxide concentrations of <20 ppm is very rare (< 1 10,000).< li>
- Bleeding time:In a preclinical study, it has been observed that inhaled nitric oxide increases bleeding time. However, in controlled clinical studies, no significant differences have been found between the test group and the treatment group regarding hemorrhagic complications.
General disorders and administration site conditions
- A lack of responseto treatment may be observed in 30 to 45% of cases.
- A significant increase in NO2 concentrations at low therapeutic doses (<20 ppm) of inhaled no, with evidence clinical toxicity due to no2, is a very rare complication (< 1 10,000).< li>
- The abrupt interruption of treatment with inhaled nitric oxide frequently (> 1/10) causes rebound reactions with an intensification of pulmonary vasoconstriction and hypoxemia.
Reporting of side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of NOXAP
Keep out of the reach and sight of children.
Do not use NOXAPafter the expiry date stated on the label, after "EXP".
All regulations regarding the handling of pressure vessels should be followed.
Storage is supervised by local hospital specialists. The vessels should be stored in well-ventilated rooms or covered, ventilated areas, protected from rain and direct sunlight.
Protect the vessels from impacts, falls, oxidizing and flammable materials, humidity, heat sources, or ignition.
Storage in the pharmacy department
The vessels should be stored in a designated area exclusively for the storage of medicinal gases, which is well-ventilated, clean, and locked. This area should have a separate and special place for the storage of nitric oxide vessels.
Storage in the medical department
The vessels should be kept in a place with the necessary equipment to ensure they remain in a vertical position.
6. Package contents and further information
Composition of NOXAP
NOXAP is a gas mixture.
- The active substance is: nitric oxide 200 ppm (mol/mol)
- The other component is: nitrogen.
Appearance and package contents
NOXAP is a compressed medicinal gas.
NOXAP is stored in high-pressure vessels made of aluminum or aluminum with an external layer of elastomers. The valves that close the vessels are made of steel. The vessel sizes are 2 l, 5 l, 10 l, 20 l, and 40 l.
NOXAP is filled as a gas in these gas cylinders at a pressure of 200 bar. Not all sizes are marketed.
Package sizes (liters) | Filling pressure (bar) | Quantity in liters of the 200 ppm NO/N2 mixture | Quantity in m3 of the 200 ppm NO/N2 mixture |
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 package color code is turquoise blue and white body.
Marketing authorization holder
S.E. de Carburos Metálicos, S.A.
Avda. de la Fama, 1
08940-Cornella de Llobregat
Spain
Manufacturer:
SE. Carburos Metálicos, S.A. |
Pol. Nord-Este C-35, Km. 59, 08470-Sant Celoni |
This medicine is authorized in the Member States of the European Economic Area under the following names:
Belgium: NOXAP 200ppm mol/mol, medicinal gas, compressed
Netherlands: NOXAP 200ppm mol/mol, medicinal gas, compressed
France: NOXAP 200 ppm mol/mol, medicinal gas, compressed
Portugal: NOXAP 200 ppm mol/mol, medicinal gas, compressed
Czech Republic: NOXAP 200 ppm mol/mol, medicinal gas, compressed
Germany: NOXAP 200 ppm Mol/Mol Gas zur medizinischen Anwendung, druckverdichtet
Spain: NOXAP 200 ppm mol/mol, medicinal gas, compressed
Poland: NOXAP 200 ppm mol/mol, medicinal gas, compressed
Italy: NOXAP 200 ppm mol/mol, medicinal gas, compressed
This package leaflet was approved inJanuary 2020
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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