NOXIVENT®

(Nitric oxide) gas, for inhalation

noxivent

NOXIVENT (nitric oxide) gas, for inhalation and NOxBOX®i nitric oxide delivery and monitoring system for inhaled nitric oxide

Full NOXIVENT Prescribing Information

NOXIVENT Indication and Important Safety Information

NOxBOXi Nitric Oxide Delivery System Indication

Ventilator Capability List

 

Comprehensive Solution for Nitric Oxide Inhalation Therapy

NOXIVENT (nitric oxide) gas, for inhalation, along with the NOxBOXi delivery and monitoring system, offered with a customizable, consumption-based billing, is backed by Linde’s national network, responsive support, and a reputation for medical gas distribution. 

The Gas

NOXIVENT (nitric oxide) gas, for inhalation is a prescription drug available to healthcare professionals trained in the administration of inhaled nitric oxide therapy.

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.

The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from the NOXIVENT therapy. Doses greater than 20 ppm are not recommended. Monitor for PaO2 and inspired NO2, and methemoglobin during NOXIVENT administration.

The Delivery System

The NOxBOXi delivery device provides intelligent nitric oxide delivery with precise real-time monitoring of nitric oxide, nitrogen dioxide, and oxygen through a touch screen with a step-by-step guided interface to enable ease of use. It is designed for in-hospital use, with portable detachable head unit to provide uninterrupted treatment during transit and transfer situations, and may be used with invasive and non-invasive ventilation.

NOXIVENT gas requires patient monitoring and management to help avoid patient complications and risks. NOXIVENT gas should only be used with a calibrated NOxBOXi delivery system operated by trained personnel. Satisfactory completion of a training program provided by us is required. Only validated ventilator systems should be used in conjunction with NOXIVENT and NOxBOXi.

Our Commitment

Integrated gas delivery system for inhaled nitric oxide therapy

24/7 service and support

Simplified billing process

Reliable and responsive distribution network

Established reputation for quality and customer satisfaction

 

To learn more about these products, please call 1 (833) 669-8368 (1-833-NOX-VENT) or email LG.US.Noxivent@linde.com.

The information contained herein is offered for use by technically qualified personnel at their discretion and risk without warranty of any kind.

Noxivent  Indication and Important Safety Information

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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.

Contraindications

NOXIVENT is contraindicated in neonates dependent on right-to-left shunting of blood.

Warnings and Precautions

Rebound: Abrupt discontinuation of NOXIVENT may lead to worsening oxygenation and increasing pulmonary artery pressure.

Methemoglobinemia: Methemoglobin levels increase with the dose of NOXIVENT ; it can take 8 hours or more before steady-state methemoglobin levels are attained. If methemoglobin levels do not resolve with decrease in dose or discontinuation of NOXIVENT , additional therapy may be warranted to treat methemoglobinemia.

Airway injury from Nitrogen Dioxide: Monitor nitrogen dioxide (NO2) levels. Nitrogen dioxide may cause airway inflammation and damage to lung tissue.

Heart Failure: In patients with pre-existing left ventricular dysfunction, NOXIVENT may increase pulmonary capillary wedge pressure leading to pulmonary edema.

Adverse Reactions: The most common adverse reaction of NOXIVENT is hypotension.

Drug Interactions: Nitric Oxide donor compounds may increase the risk of developing methemoglobinemia.

Administration: Use only with a calibrated NOxBOXi delivery system operated by trained personnel. Only validated ventilator systems should be used in conjunction with NOXIVENT .

Please see full NOXIVENT prescribing information for additional NOXIVENT safety and risk information.

NOxBOXi Nitric Oxide Delivery System Indication

NOxBOXi Nitric Oxide Delivery system is intended for use by healthcare professionals for the delivery and monitoring of a constant (use set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing inhaled nitric oxide therapy (iNO). The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, contraindications, warnings, and precautions described in the nitric oxide drug packaging inserts and labelling (currently neonates). Refer to this material prior to use.