Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Nitric oxide
SOL S.p.A.
R07AX; R07AX01
Nitric oxide
225 ppm mole(s)
Medicinal gas, compressed
Product subject to prescription which may not be renewed (A)
Other respiratory system products; nitric oxide
Marketed
2013-04-12
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. · 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. This includes any possible side effects not listed in this leaflet. See section 4 What is in this leaflet: 1. What Neophyr is and what it is used for 2. What you need to know before you use Neophyr 3. How to use Neophyr 4. Possible side effects 5. How to store Neophyr 6. Contents of the pack and other information 1. What Neophyr is and what it is used for Neophyr is a gas mixture for inhalation use. Neophyr is a medicinal gas, compressed, consisting of a mixture of gases that contains 225 ppm, 450 ppm or 1000 ppm mol/mol o f nitric oxide. What are its uses? Neophyr must be administered exclusively by healthcare professionals and it is only for strict hospital use. Neophyr is indicated in the following conditions: · newborn babies with lung failure associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure. When inhaled, this gas mixture can improve the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches your baby’s blood. · newborn babies, babies, children, teenagers 0-17 years and adults with high blood pressure in the lungs, connected with heart surgery. This gas mixture can improve heart function and increase the flow of blood through the lungs. 2. What you need to know before you use Neophyr Do not use Neophyr · If you (as the patient) or your child (as the patient) are allergic (hypersensitive) to nitric oxide or any of the other ingredients of this medicine (listed in section 6). · If you have been told that you (as the patient) or your child (as the patient) have an abnormal circulation withi Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 16 May 2023 CRN00CGX6 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neophyr 225 ppm mol/mol, medicinal gas, compressed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide 225ppm mol/mol. Nitric oxide (NO) 0.225 ml in Nitrogen (N 2 ) 999.775 ml. A 10-liter gas cylinder filled to 150 bar supplies 1500 lof gas at a pressure of 1 bar at 15°C. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicinal gas, compressed. Colourless and odourless gas. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neophyr, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ≥ 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation. as part of the treatment of perioperative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Persistent Pulmonary Hypertension in the Newborn (PPHN)_ Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care. Prescription should be limited to those neonatal units that have received adequate training in the use of a nitric oxide delivery system. Neophyr should only be delivered according to a neonatologist's prescription. Neophyr should be used in ventilated newborn infants expected to require support >24 hours. Neophyr should be used only after respiratory support has been optimised. This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure). _Pulmonary hypertension associ Olvassa el a teljes dokumentumot