Neophyr 1000 ppm mol/mol, medicinal gas, compressed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitric oxide

Available from:

SOL S.p.A.

ATC code:

R07AX; R07AX01

INN (International Name):

Nitric oxide

Dosage:

1000 ppm mole(s)

Pharmaceutical form:

Medicinal gas, compressed

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other respiratory system products; nitric oxide

Authorization status:

Marketed

Authorization date:

2013-04-12

Patient Information leaflet

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.
·
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
·
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 Neophyr is and what it is used for
2. What you need to know before you use
Neophyr
3. How to use Neophyr
4. Possible side effects
5. How to store Neophyr
6. Contents of the pack and other information
1. What Neophyr is and what it is used for
Neophyr is a gas mixture for inhalation use.
Neophyr is a medicinal gas, compressed,
consisting of a mixture of gases that contains
225 ppm, 450 ppm or 1000 ppm mol/mol o
f nitric oxide.
What are its uses?
Neophyr must be administered exclusively by
healthcare professionals and it is only for strict
hospital use.
Neophyr is indicated in the following conditions:
·
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.
2. What you need to know before you use
Neophyr
Do not use Neophyr
·
If you (as the patient) or your child (as the
patient) are allergic (hypersensitive) to nitric
oxide or any of the other ingredients of this
medicine (listed in section 6).
·
If you have been told that you (as the patient) or
your child (as the patient) have an abnormal
circulation withi

Summary of Product characteristics

Health Products Regulatory Authority
16 May 2023
CRN00CGX6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neophyr 1000 ppm mol/mol, medicinal gas, compressed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitric oxide 1000ppm mol/mol.
Nitric oxide (NO) 1 ml in
Nitrogen (N
2
) 999 ml.
A 2-liter gas cylinder filled to 150 bar supplies 300 lof gas at a
pressure of 1 bar at 15°C.
A 10-liter gas cylinder filled to 150 bar supplies 1500 lof gas at a
pressure of 1 bar at 15°C.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicinal gas, compressed.
Colourless and odourless gas.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Neophyr, 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 perioperative 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. Neophyr should only be delivered according to a
neonatologist's prescription.
Neophyr should be used in ventilated newborn infants expected to
require support >24 hours. Neophyr should be used only
after respiratory support has been optimised. This includes optimising
tidal volume/pressures and lung recruitment (surfactant,
high fre