Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Nitric oxide
Linde Healthcare AB
R07AX
nitric oxide
Other respiratory system products
Hypertension, Pulmonary; Respiratory Insufficiency
INOmax, 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 peri- and post-operative 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.
Revision: 23
Authorised
2001-08-01
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER INOMAX 400 PPM MOL/MOL MEDICINAL GAS, COMPRESSED 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, ask your doctor - 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 INOmax is and what it is used for 2. What you need to know before you begin a treatment with INOmax 3. How INOmax is given 4. Possible side effects 5. How to store INOmax 6. Contents of the pack and other information 1. WHAT INOMAX IS AND WHAT IT IS USED FOR INOmax contains nitric oxide, a gas used for the treatment of 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, which may help to increase the amount of oxygen that reaches the blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU BEGIN A TREATMENT WITH INOMAX DO NOT USE INOMAX - If you (as the patient) or your child (as the patient) are allergic (hypersensitive) to nitric oxide or any other ingredients of INOmax (see section 6 ‘further information’ where the full list of ingredients is provided). - If you have been told that you (as the patient) or your child (as the patient) have an abnormal circulation within the heart. WARNINGS AND PRECAUTIONS Inhaled nitric oxide may not always be effective and thus other therapies may be considered necessary for you or your child. Inhaled n Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol medicinal gas, compressed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 400 ppm mol/mol. A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15 o C. A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15 o C. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Medicinal gas, compressed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INOmax, 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 peri- and post-operative 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. INOmax should only be delivered according to a neonatologist’s prescription. INOmax should be used in ventilated newborn infants expected to require support >24 hours. INOmax 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 a Lue koko asiakirja