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Indication & safety information Indication & safety info
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Indication & Safety Information

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 the treatment of neonates dependent on right-to-left shunting of blood.
  • Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
  • Methemoglobin, NO2 and PaO2 should be monitored during nitric oxide administration.
  • In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema. The most common adverse reaction is hypotension.
  • Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
  • Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.
  • See package insert for additional Important Safety Information.