VasoKINOX nitric oxide 450 ppm mol/mol medicinal gas compressed gas cylinder

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitric oxide, Quantity: 0.0004 mol

Available from:

Air Liquide Healthcare Pty Ltd

INN (International Name):

Nitric oxide

Pharmaceutical form:

Gas, medicinal

Composition:

Excipient Ingredients: nitrogen

Administration route:

Inhalation

Units in package:

20L, 11L, 5L

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VasoKINOX is indicated in conjunction with ventilator support and other appropriate active substances 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: No Temperature on label; Container Closure: Restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-01-16

Patient Information leaflet

1
CONSUMER MEDICINE INFORMATION
VASOKINOX

VasoKINOX Consumer Medicine Information / Version: proposed March 2018
CONSUMER MEDICINE INFORMATION
VASOKINOX® 450PPM
(nitric oxide for inhalation), medicinal gas compressed
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
VasoKINOX 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
VasoKINOX against the benefits
it is expected to have for you or
your child.
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 VASOKINOX COME
IN?
VasoKINOX is a medicinal
product that is in the form of a
gas and is packaged in gas
cylinders in a concentration of
450 parts per million (ppm).
WHAT DOES VASOKINOX
CONTAIN?
The active substance is nitric
oxide, its dosage is 450 ppm
mole/mole.
The other ingredient is
nitrogen.
Nitrogen is a major component
of the air we breathe.
WHAT IS VASOKINOX
USED FOR?
VasoKINOX is a gas mixture,
composed of nitric oxide and
nitrogen, used to treat acute
pulmonary hypertension
(increase in blood pressure in
the pulmonary circulation),
which can occur during heart
surgery.
VasoKINOX is a ‘PRESCRIPTION
ONLY MEDICINE’. It is to be
given only to the person for
whom it has been prescribed.
HOW VASOKINOX
WORKS?
VasoKINOX can improve the
flow of blood through the lungs
by relaxing the cells in the blood
vessels and allowing the blood
vessels to widen. This may help
to decrease the blood pressure
and increase the amount of
oxygen that reaches the blood.
WHEN VASOKINOX
SHOULD NOT BE USED
DO NOT USE VASOKINOX IF:
•
YOU ARE ALLERGIC TO NITRIC
OXIDE OR NITROGEN
•
in newborns who have the
following heart defects:
-
RIGHT-TO-LEFT SHUNT
-
MALIGNANT LEFT-RIGHT
ARTERIAL CANAL
VASOKINOX SHOULD NOT BE USED
IN PREMATURE INFANTS BORN
BEFORE 34 WEEKS FROM
CONCEPTION.
Tell your d

Summary of Product characteristics

PRODUCT INFORMATION
VASOKINOX

VasoKINOX –AUST R 235184
1 /14
AUSTRALIAN PRODUCT INFORMATION – VASOKINOX (NITRIC OXIDE) 445 PPM
MEDICINAL GAS
1.
NAME OF THE MEDICINE
VasoKINOX® 450ppm (nitric oxide for inhalation), medicinal gas
compressed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VasoKINOX is a colourless and odourless medicinal gas. Nitric oxide
(NO), the active ingredient of
VasoKINOX, is a pulmonary vasodilator. VasoKINOX is supplied in
aluminium alloy gas cylinders (of 5L or
11L or 20L capacity) with a NO concentration of 450ppm mol/mol (NO
0.450 ml in Nitrogen (N
2
) 999.55
ml).
3.
PHARMACEUTICAL FORM
A 5-litre cylinder filled to 200 bar (20,000 kPa) supplies 0.94m
3
of gas at a pressure of 1 bar (101.3kPa) at
15°C
A 11-litre cylinder filled to 200 bar (20,000 kPa) supplies 2.1m
3
of gas at a pressure of 1 bar (101.3kPa) at
15°C
A 20-litre cylinder filled to 200 bar (20,000 kPa) supplies 3.8m
3
of gas at a pressure of 1 bar (101.3kPa) at
15°C.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VasoKINOX is indicated in conjunction with ventilator support and
other appropriate active substances
to
selectively
decrease
pulmonary
arterial
pressure
in
patients
with
perioperative
pulmonary
hypertension in conjunction with heart surgery
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Prescription of NO should be supervised by a physician experienced in
cardiothoracic anaesthesia & intensive
care. Prescription should be limited to those cardio-thoracic units
that have received adequate training
in the use of a NO delivery system. VasoKINOX should only be delivered
according to an anaesthetist’s or
intensive care physician’s prescription.
VasoKINOX should be used only after respiratory support has been
optimised, according to the current
clinical practices. Inhaled NO is usually given in addition to other
standard treatment regimes in the peri-
operative
setting,
including
inotropic
and
vasoactive
medicinal
products.
VasoKINOX
should
be
administered under close monitoring of haemodynamics and oxygena