INOmax
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
20-04-2023
Summary of Product characteristics
(SPC)
20-04-2023
Public Assessment Report
(PAR)
28-02-2013
Active ingredient:
Nitric oxide
Available from:
Linde Healthcare AB
ATC code:
R07AX
INN (International Name):
nitric oxide
Therapeutic group:
Other respiratory system products
Therapeutic area:
Hypertension, Pulmonary; Respiratory Insufficiency
Therapeutic indications:
INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation 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;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
Product summary:
Revision: 23
Authorization status:
Authorised
Authorization date:
2001-08-01
Patient Information leaflet
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
INOMAX 400
PPM MOL/MOL MEDICINAL GAS, COMPRESSED
Nitric oxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1.
What INOmax is and what it is used for
2.
What you need to know before you begin a treatment with INOmax
3.
How INOmax is given
4.
Possible side effects
5.
How to store INOmax
6.
Contents of the pack and other information
1.
WHAT INOMAX IS AND WHAT IT IS USED FOR
INOmax contains nitric oxide, a gas used for the treatment of
newborn babies with lung failure associated with high blood pressure
in the lungs, a condition
known as hypoxic respiratory failure. When inhaled, this gas mixture
can improve the flow of
blood through the lungs, which may help to increase the amount of
oxygen that reaches your
baby’s blood.
newborn babies, babies, children, teenagers 0-17 years and adults with
high blood pressure in
the lungs, connected with heart surgery. This gas mixture can improve
heart function and
increase the flow of blood through the lungs, which may help to
increase the amount of oxygen
that reaches the blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU BEGIN A TREATMENT WITH INOMAX
DO NOT USE INOMAX
-
If you (as the patient) or your child (as the patient) are allergic
(hypersensitive) to nitric oxide or
any other ingredients of INOmax (see section 6 ‘further
information’ where the full list of
ingredients is provided).
-
If you have been told that you (as the patient) or your child (as the
patient) have an abnormal
circulation within the heart.
WARNINGS AND PRECAUTIONS
Inhaled nitric oxide may not always be effective and thus other
therapies may be considered necessary
for you or your child.
Inhaled n
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
INOmax 400 ppm mol/mol medicinal gas, compressed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitric oxide (NO) 400 ppm mol/mol.
A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of
gas under pressure of 1 bar at 15
o
C.
A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres
of gas under pressure of 1 bar at
15
o
C.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Medicinal gas, compressed.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INOmax, in conjunction with ventilatory support and other appropriate
active substances, is indicated:
for the treatment of newborn infants
34
_ _
weeks gestation 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.
as part of the treatment of peri- and post-operative pulmonary
hypertension in adults and
newborn infants, infants and toddlers, children and adolescents, ages
0-17 years in conjunction
to heart surgery, in order to selectively decrease pulmonary arterial
pressure and improve right
ventricular function and oxygenation.
4.2
POSOLOGY 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 newborn infants expected to
require support >24 hours. INOmax
should be used only after respiratory support has been optimised. This
includes optimising tidal
volume/pressures and lung recruitment (surfactant, high frequency
ventilation, and positive end
expiratory pressure).
_Pulmonary hypertension a
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