INOMAX GAS

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

NITRIC OXIDE

Verfügbar ab:

INO THERAPEUTICS

ATC-Code:

R07AX01

INN (Internationale Bezeichnung):

NITRIC OXIDE

Dosierung:

800PPM

Darreichungsform:

GAS

Zusammensetzung:

NITRIC OXIDE 800PPM

Verabreichungsweg:

INHALATION

Einheiten im Paket:

353/1963L

Verschreibungstyp:

Prescription

Therapiebereich:

NITRATES AND NITRITES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0151361002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2005-09-23

Fachinformation

PRODUCT MONOGRAPH
INOMAX
®
NITRIC OXIDE FOR INHALATION
800 ppm
Distributed by:
C.R.I.
4 Innovation Drive
Dundas ON
Canada L9H 7P3
Manufactured by:
Mallinckrodt Manufacturing LLC
1060 Allendale Drive
Port Allen, LA 70767
Control Number:
Date of Revision:
199061
OCTOBER 4, 2017
Page 2 of 27
PRODUCT MONOGRAPH
INOMAX
®
NITRIC OXIDE FOR INHALATION
800 ppm
ACTIONS AND CLINICAL PHARMACOLOGY
Nitric oxide is a compound produced by many cells of the body. It
relaxes vascular
smooth muscle by binding to the heme moiety of cytosolic guanylate
cyclase, activating
guanylate cyclase and increasing intracellular levels of cyclic
guanosine
3’,5’-monophosphate, which then leads to vasodilation. When
inhaled, nitric oxide
produces selective pulmonary vasodilation. Nitric oxide is very
rapidly inactivated by
binding to hemoglobin. Thus, delivered via inhalation, nitric oxide
improves V/Q
matching and is a selective pulmonary vasodilation agent.
Inhaled nitric oxide appears to increase the partial pressure of
arterial oxygen (PaO
2
) by
dilating pulmonary vessels in better ventilated areas of the lung,
redistributing
pulmonary blood flow away from lung regions with low
ventilation/perfusion (V/Q) ratios
toward regions with normal ratios.
Effects on Pulmonary Vascular Tone in PPHN: Persistent pulmonary
hypertension of
the newborn (PPHN) occurs as a primary developmental defect or as a
condition
secondary to other diseases such as meconium aspiration syndrome
(MAS),
pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic
hernia
(CDH), and pulmonary hypoplasia. In these states, pulmonary vascular
resistance
(PVR) is high, which results in hypoxemia secondary to right-to-left
shunting of blood
through the patent ductus arteriosus and foramen ovale. Inhalation of
nitric oxide
reduces the oxygenation index (OI= mean airway pressure in cm H
2
O x fraction of
inspired oxygen concentration [FiO
2
] x 100 divided by systemic arterial concentration in
mm Hg [PaO
2
]) and increases PaO
2
.
CLINICAL STUDIES
The efficacy of INO