INOmax nitric oxide 800 ppm medicinal gas for inhalation cylinder

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitric oxide, Quantity: 0.08 % w/w

Available from:

Ikaria Australia Pty Ltd

INN (International Name):

Nitric oxide

Pharmaceutical form:

Gas, medicinal

Composition:

Excipient Ingredients: nitrogen

Administration route:

Inhalation

Units in package:

Size 88 cylinder, Size MD15 cylinder

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INOmax?, in conjunction with ventilatory support and other appropriate agents, is indicated -,- for the treatment of term and near-term ( greater than 34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.,- to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery

Product summary:

Visual Identification: Colourless gas; Container Type: Gas Cylinder; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-11-22

Patient Information leaflet

INOMAX
®
Nitric oxide medicinal gas for inhalation
CONSUMER MEDICINE INFORMATION
INOmax
®
_Version – 29 March 2019_
1
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
INOMAX®
.
It does not
contain all the available
information. It does not take
the place of talking to your
specialist, doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed up the risks of using
INOmax® against the
benefits it is expected to
have for you.
IF YOU HAVE ANY QUESTIONS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may
need to read it again.
WHAT DOSAGE FORM
DOES INOMAX® COME
IN?
INOmax® is a therapeutic
product that is in the form of
a gas and is packaged in gas
cylinders in a concentration
of 800 parts per million
(ppm).
WHAT DOES INOMAX®
CONTAIN?
MEDICINAL INGREDIENT IS:
Nitric oxide
NON-MEDICINAL INGREDIENTS
ARE:
Nitrogen is the only inactive
ingredient. Nitrogen is a
major component of the air
we breathe.
WHAT IS INOMAX®
USED FOR?
Babies who have been born
near (>34 weeks) or at term
and
who
have
been
diagnosed
with
a
condition
called
hypoxic
respiratory
failure
may
be
given
INOmax®.
A baby with hypoxic
respiratory failure has less
blood flow through the
lungs, and low amounts of
oxygen in the blood. Some
medical conditions, such as
pulmonary hypertension
(high blood pressure in the
lung), meconium aspiration
(stained amniotic fluid in the
lungs) and infection, may
cause hypoxic respiratory
failure.
INOmax® may also be given
in patients who are having,
or just had, heart surgery and
develop high blood pressure
in the lungs. In these
patients, INOmax® is used
to help reduce blood pressure
in the lungs.
Before your doctor
prescribes INOmax®, other
types of therapy may be
given to try to improve your
condition. If these other
therapies do not improve
your condition, INOmax®
may be given.
INOmax® is a
‘PRESCRIPTION ONLY
MEDICINE’. It is to be
given only to the person for
whom it has been prescribed.
HOW INOMAX® WORKS
INOmax® c

Summary of Product characteristics

INOmax® Product Information / Version 1.8 April 30 2019
1/19
AUSTRALIAN PRODUCT INFORMATION
INOMAX® (NITRIC OXIDE) MEDICINAL GAS FOR INHALATION CYLINDER
1.
NAME OF THE MEDICINE
Nitric oxide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INOMAX®
(nitric oxide) is a drug administered by inhalation. Nitric oxide, the
active substance in
INOmax®, is a pulmonary vasodilator. INOmax® is a gaseous blend of
nitric oxide and nitrogen (0.08%
and 99.92%, respectively for 800 ppm). INOmax® is supplied in
aluminium cylinders as a compressed gas
under high pressure (13, 789.51 kPa gauge).
3.
PHARMACEUTICAL FORM
Medicinal Gas for Inhalation Cylinder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INOmax®, in conjunction with ventilatory support and other
appropriate agents, is indicated ─
•
for the treatment of term and near-term (>34 weeks) neonates with
hypoxic respiratory failure
associated with clinical or echocardiographic evidence of pulmonary
hypertension, in order to
improve oxygenation and to reduce the need for extracorporeal membrane
oxygenation.
•
to selectively decrease pulmonary arterial pressure in patients with
perioperative pulmonary
hypertension in conjunction with heart surgery .
4.2
DOSE AND METHOD OF ADMINISTRATION
_Persistent Pulmonary Hypertension in the Newborn (PPHN) _
Prescription of nitric oxide should be supervised by a physician
experienced in neonatal intensive care.
Prescription should be limited to those neonatal units that have
received adequate training in the use of a
nitric
oxide
delivery
system.
INOmax®
should
only
be
delivered
according
to
a
neonatologist’s
prescription.
INOmax® should be used in ventilated infants expected to require
support > 24 hours. INOmax® should
be used only after respiratory support has been optimised. This
includes optimising tidal volume/pressure
and lung recruitment (surfactant, high frequency ventilation, and
positive end expiratory pressure).
DOSAGE
INOmax® should only be used after respiratory support is optimised
including the use of surfa