United States - English - NLM (National Library of Medicine)

ino therapeutics llc - nitric oxide (unii: 31c4ky9esh) (nitric oxide - unii:31c4ky9esh) - nitric oxide 0.98 mg in 1 l - inomax® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. inomax is contraindicated in neonates dependent on right-to-left shunting of blood. the safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see clinical studies (14.1)]. additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see clinical studies (14.3)]. no information about its effectiveness in other age populations is available. nitric oxide is not indicated for use in the adult population.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

messer belgium sa-nv - nitric oxide 800 ppm v/v - medicinal gas, compressed - 800 ppm v/v - nitric oxide - nitric oxide

Australia - English - Department of Health (Therapeutic Goods Administration)

ikaria australia pty ltd - nitric oxide, quantity: 0.08 % w/w - gas, medicinal - excipient ingredients: nitrogen - inomax?, in conjunction with ventilatory support and other appropriate agents, is indicated -,- for the treatment of term and near-term ( greater than 34 weeks) neonates 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.,- to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery

Australia - English - Department of Health (Therapeutic Goods Administration)

air liquide healthcare pty ltd - nitric oxide, quantity: 0.0004 mol - gas, medicinal - excipient ingredients: nitrogen - vasokinox is indicated in conjunction with ventilator support and other appropriate active substances to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery

United States - English - NLM (National Library of Medicine)

airgas specialty gases - nitric oxide (unii: 31c4ky9esh) (nitric oxide - unii:31c4ky9esh), nitrogen (unii: n762921k75) (nitrogen - unii:n762921k75) -

United States - English - NLM (National Library of Medicine)

vero biotech, inc. - nitric oxide (unii: 31c4ky9esh) (nitric oxide - unii:31c4ky9esh) - genosyl ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. genosyl is contraindicated in neonates dependent on right-to-left shunting of blood. the safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see clinical studies (14.1)] . additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see clinical studies (14.3)] . no information about its effectiveness in other age populations is available. nitric oxide is not indicated for use in the adult population.

United States - English - NLM (National Library of Medicine)

vero biotech, inc. - nitric oxide (unii: 31c4ky9esh) (nitric oxide - unii:31c4ky9esh) - genosyl® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. genosyl is contraindicated in neonates dependent on right-to-left shunting of blood. the safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see clinical studies (14.1)] . additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see clinical studies (14.3)] . no information about its effectiveness in other age populations is available. nitric oxide is not indicated for use in the adult population. vero biotech inc. 387 technology circle n

Ireland - English - HPRA (Health Products Regulatory Authority)

sol s.p.a. - nitric oxide - medicinal gas, compressed - 225 ppm mole(s) - other respiratory system products; nitric oxide

Ireland - English - HPRA (Health Products Regulatory Authority)

sol s.p.a. - nitric oxide - medicinal gas, compressed - 1000 ppm mole(s) - other respiratory system products; nitric oxide

Ireland - English - HPRA (Health Products Regulatory Authority)

sol s.p.a. - nitric oxide - medicinal gas, compressed - 450 ppm mole(s) - other respiratory system products; nitric oxide