NOXIVENT GAS

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

NITRIC OXIDE

Tilgængelig fra:

PRAXAIR CANADA INC

ATC-kode:

R07AX01

INN (International Name):

NITRIC OXIDE

Dosering:

800PPM

Lægemiddelform:

GAS

Sammensætning:

NITRIC OXIDE 800PPM

Indgivelsesvej:

INHALATION

Enheder i pakken:

348L/2239L

Recept type:

Prescription

Terapeutisk område:

NITRATES AND NITRITES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2016-01-25

Produktets egenskaber

_PR_
Noxivent™ (nitric oxide for Inhalation)
Praxair Canada Inc.
Page 1 of 29
PRODUCT MONOGRAPH
_PR_
_NOXIVENT_

NITRIC OXIDE FOR INHALATION
100 ppm and
800 ppm
Medical Gas
Praxair Canada Inc.
1 City Centre Drive, Suite 1200,
Mississauga, ON L5B 1M2
Control Number:
175320
Date of Preparation:
January 22, 2016
_PR_
Noxivent™ (nitric oxide for Inhalation)
Praxair Canada Inc.
Page 2 of 29
PRODUCT MONOGRAPH
_PR_
_NOXIVENT_

NITRIC OXIDE FOR INHALATION
100 ppm and
800 ppm
Medical Gas
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
con