Nitrous oxide Medicinal SOL, 100 % v/v, medicinal gas, liquefied

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Nitrous oxide

Disponibil de la:

SOL S.p.A.

Codul ATC:

N01AX; N01AX13

INN (nume internaţional):

Nitrous oxide

Dozare:

100 percent volume/volume

Forma farmaceutică:

Medicinal gas, liquefied

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Other general anesthetics; nitrous oxide

Statutul autorizaţiei:

Authorised

Data de autorizare:

2016-07-08

Prospect

Nitrous oxide Medicinal SOL 100 % v/v medicinal gas, liquefied
PIL – Page 1of 10
November 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITROUS OXIDE MEDICINAL SOL 100 % V/V MEDICINAL GAS, LIQUEFIED
nitrous 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nitrous oxide Medicinal SOL is and what it is used for
2.
What you need to know before you use Nitrous oxide Medicinal SOL
3.
How to use Nitrous oxide Medicinal SOL
4.
Possible side effects
5.
How to store Nitrous oxide Medicinal SOL
6.
Contents of the pack and other information
1.
WHAT NITROUS OXIDE MEDICINAL SOL IS AND WHAT IT IS USED FOR
Nitrous oxide Medicinal SOL is a colourless, sweet smelling inhalation
gas (intended for
breathing in). The active substance is nitrous oxide, otherwise known
as “laughing gas”. It
belongs to the group of general anaesthetics (narcotic agents).
Nitrous oxide Medicinal SOL is used in adults and children from the
age of 1 month:
-
In combination with oxygen (50% nitrous oxide and 50% oxygen) for
relief of short-term,
intermittent, mild to moderate pain.
-
In mixture with a minimum of 21% oxygen as a basic anaesthetic in
combination with other
anaesthetics.
2.
WHAT YOU NEED TO NOW BEFORE YOU USE NITROUS OXIDE MEDICINAL SOL
DO NOT USE NITROUS OXIDE MEDICINAL SOL
if you have:
-
To inhale 100% medical oxygen regularly or constantly
-
Air trapped in a part of the body where it’s expansion may be
dangerous, such as in
collapsed lung (pneumothorax),
in breathing difficulties such as emphysema or in
decompression sickness (the bends)
-
Undergone a bypass surgery with or without heart lung machine
-
In patients with cardiac disease (i.e hea

Caracteristicilor produsului

Health Products Regulatory Authority
28 September 2020
CRN008JWC
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitrous oxide Medicinal SOL, 100 % v/v, medicinal gas, liquefied
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrous oxide (N
2
O), 100% v/v
3 PHARMACEUTICAL FORM
Medicinal gas, liquefied
Colourless and odourless gas
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Nitrous oxide Medicinal SOL in equimolar concentration with oxygen
(50% v/v nitrous oxide and 50% v/v oxygen)
is indicated for the treatment of short-term pain conditions of mild
to moderate intensity when rapid analgesic
onset and offset effects are required, in adults and in children older
than 1 month.

Nitrous oxide Medicinal SOL is used as a basic anaesthetic in
combination with inhalation anaesthetics or
intravenous anaesthetics in adults and children from the age of 1
month. Medical oxygen is added at a
concentration of at least 21% v/v.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Analgesia_
Administration of Nitrous oxide Medicinal SOL in an equimolar mixture
with oxygen should commence shortly before the
desired analgesic effect is required. The analgesic effect is seen
after 4-5 breaths and reaches its maximum within 2-3 minutes.
Administration of Nitrous oxide Medicinal SOL should continue
throughout the painful procedure, or for as long as the
analgesic effect is desired. Following discontinuation of the
administration/inhalation, the effects wear off quickly within a few
minutes.
According to the individual pain relieving reaction in the patient,
additional analgesics
may be required.
Nitrous oxide, as an analgesic, in an equimolar mixture with oxygen,
may not be administered for longer than 1 hour
continuously and should not be used for more than 15 consecutive days.
_Anaesthesia_
Nitrous oxide acts as a basal anaesthetic to achieve anaesthesia.
Nitrous oxide alone, with a maximum permitted concentration
of 79 % v/v, cannot induce anaesthesia. In combination with other
inhalation a