Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
NITRIC OXIDE (UNII: 31C4KY9ESH) (NITRIC OXIDE - UNII:31C4KY9ESH)
Linde Gas & Equipment Inc
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Noxivent™ is a vasodilator 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. Neonates dependent on right-to-left shunting of blood ( 4). Noxivent™ is a vasodilator 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. Noxivent™ 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
Noxivent™ (nitric oxide) is available in the following sizes: Store at 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. All regulations concerning handling of pressure vessels must be followed. Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition. Occupational Exposure The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO 2 the limit is 5 ppm. Distributed by Linde Gas & Equipment 10 Riverview Drive Danbury, CT 06810-6268 © 2021 Linde Inc. MDI-7003 (Rev.01)
Abbreviated New Drug Application
NOXIVENT 101- NOXIVENT 101 GAS LINDE GAS & EQUIPMENT INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NOXIVENT™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOXIVENT™. NOXIVENT™ (NITRIC OXIDE) GAS, FOR INHALATION INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Dosage and Administration ( 2.2) 10/2015 INDICATIONS AND USAGE Noxivent™ is a vasodilator 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. DOSAGE AND ADMINSTRATION The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved ( 2.1). Doses greater than 20 ppm are not recommended ( 2.1, 5.2) Administration: • Use only with a NOxBOXi operated by trained personnel ( 2.2) • Avoid abrupt discontinuation ( 2.2, 5.1). DOSAGE FORMS AND STRENGTHS Noxivent™(nitric oxide) is a gas available in 100 ppm and 800 ppm concentrations ( 3). CONTRAINDICATIONS Neonates dependent on right-to-left shunting of blood ( 4). WARNINGS AND PRECAUTIONS Rebound: Abrupt discontinuation of Noxivent™ may lead to worsening oxygenation and ® increasing pulmonary artery pressure ( 5.1). Methemoglobinemia: Methemoglobin increases with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours ( 5.2). Elevated NO Levels: Monitor NO levels ( 5.3). Heart Failure: In patients with pre-existing left ventricular dysfunction, Noxivent™ may increase pulmonary capillary wedge pressure leading to pulmonary edema ( 5.4). ADVERSE REACTIONS The most common adverse reaction is hypotension. ( 6). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LINDE, INC. AT 1-800- 772-9247 AND HTTP://WWW.L Lire le document complet