INOMAX GAS

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

NITRIC OXIDE

Dostupné s:

INO THERAPEUTICS

ATC kód:

R07AX01

INN (Mezinárodní Name):

NITRIC OXIDE

Dávkování:

100PPM

Léková forma:

GAS

Složení:

NITRIC OXIDE 100PPM

Podání:

INHALATION

Jednotky v balení:

353/1963L

Druh předpisu:

Prescription

Terapeutické oblasti:

NITRATES AND NITRITES

Přehled produktů:

Active ingredient group (AIG) number: 0151361001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2015-07-31

Charakteristika produktu

INOmax
®
(nitric oxide) for Inhalation
INO Therapeutics
PRODUCT MONOGRAPH
INOMAX
®
NITRIC OXIDE FOR INHALATION
100 ppm
800 ppm
Distributed by:
C.R.I.
4 Innovation Drive
Dundas ON
Canada L9H 7P3
Manufactured by:
INO Therapeutics,
a subsidiary of Ikaria, Inc.
Perryville III Corporate Park,
53 Frontage Road, Third Floor
Hampton, NJ 08827-9001
CONTROL NUMBER:
Date of Revision:
167232
February 12, 2014
INOmax
®
(nitric oxide) for Inhalation
INO Therapeutics
Page 2 of 27
PRODUCT MONOGRAPH
INOMAX
®
NITRIC OXIDE FOR INHALATION
100 ppm
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 i