INOMAX GAS

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

NITRIC OXIDE

थमां उपलब्ध:

INO THERAPEUTICS

ए.टी.सी कोड:

R07AX01

INN (इंटरनेशनल नाम):

NITRIC OXIDE

डोज़:

100PPM

फार्मास्यूटिकल फॉर्म:

GAS

रचना:

NITRIC OXIDE 100PPM

प्रशासन का मार्ग:

INHALATION

पैकेज में यूनिट:

353/1963L

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

NITRATES AND NITRITES

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2015-07-31

उत्पाद विशेषताएं

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