MEDICAL GRADE, NITROUS OXIDE

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

nitrous oxide, Quantity: 0.99 L/L

Dostupné s:

BOC Limited

INN (Mezinárodní Name):

Nitrous oxide

Léková forma:

Gas, medicinal

Složení:

Excipient Ingredients:

Podání:

Inhalation

Jednotky v balení:

various

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

INDICATIONS AS AT 2 NOVEMBER 2001: Nitrous oxide is indicated in adults and children for: 1. General anaesthesia, usually as an adjuvant to other volatile or intravenous anaesthetics. 2. Analgesia (with oxygen) eg. dentistry and obstetrics.

Přehled produktů:

Visual Identification: Colourless gas; Container Type: Gas Cylinder

Stav Autorizace:

Registered

Datum autorizace:

1992-01-02

Informace pro uživatele

D:\My Documents\Regulatory Affairs Files\Medical Gases\CMI's TGA
Approved\ARTG 34466 N2O Compressed\CMI - 27.03.08.doc
1
NITROUS OXIDE MEDICAL EP GRADE
Nitrous oxide, N
2
O
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
nitrous
oxide.
It
does
not
contain
all
the
available
information.
It does not take the place of talking
to
your
doctor,
anaesthetist,
surgeon or dentist.
All
medicines
have
risks
and
benefits. Your doctor or dentist has
weighed
the
risks
of
you
using
nitrous
oxide
against
the
benefits
they expect it will have for you.
If
you
have
any
concerns
about
using nitrous oxide, ask your doctor
or dentist.
Keep this leaflet with you, you may
want to read it again.
WHAT
NITROUS
OXIDE
IS
USED FOR
Nitrous
oxide
is
a
gas
used
for
general anaesthesia or pain relief.
It
is
usually
given
with
another
anaesthetic gas and oxygen during
surgery via a tube placed down your
throat by an anaesthetist or given
with
oxygen
via
a
mask
by
your
doctor or dentist.
Nitrous
oxide
works
by
causing
unconsciousness
(deep
sleep)
before and during surgery and by
relieving pain for certain procedures.
Your doctor may prescribe nitrous
oxide for another purpose. Ask your
doctor
if
you
have
any
questions
about why nitrous oxide has been
prescribed for you.
This medicine is available only with a
doctor's prescription.
BEFORE YOU USE NITROUS
OXIDE
_WHEN YOU MUST NOT USE IT_
DO NOT USE NITROUS OXIDE IF:
1. YOU HAVE AN ALLERGY TO NITROUS
OXIDE OR ANY OTHER COMPONENT IN
THE GAS OR HAVE HAD AN ALLERGIC
REACTION IN THE PAST.
2. YOU HAVE A CONDITION WHERE AIR
IS ENTRAPPED WITHIN YOUR BODY AND
IT
MIGHT
EXPAND
WHEN
GIVEN
NITROUS
OXIDE
(EG
BOWEL
OBSTRUCTION, BLOCKED MIDDLE EAR,
FOLLOWING A RECENT DIVE). ASK YOUR
DOCTOR
FOR
FULL
DETAILS
OF
THESE
CONDITIONS.
3. YOU HAVE BEEN USING IT FOR A
PROLONGED PERIOD WITHOUT PROPER
MONITORING OF YOUR BLOOD.
4.
DO
NOT
USE
NITROUS
OXIDE
WITHOUT THE NECESSARY AMOUNT OF
OXYGEN.
5. YOU ARE INTOXICATED.
Do
not
use
nitrous
oxide
if
the
cylinder is damaged or sh

Charakteristika produktu

1
AUSTRALIAN PRODUCT
INFORMATION
BOC GASES NITROUS OXIDE 99.0%V/V MEDICAL E.P. GRADE GAS MEDICINAL
1.
NAME OF THE MEDICINE
Nitrous Oxide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrous oxide 99%
Complies with the requirements of the current European Pharmacopoeia
monograph for Nitrous
oxide.
Nitrous oxide
98.0% v/v minimum
Carbon dioxide 300 ppm v/v maximum
Carbon monoxide
5 ppm v/v maximum
Oxides of nitrogen (NO/NO2) 2 ppm v/v maximum
Water (vapour) 67 ppm v/v maximum
There are no excipients
3.
PHARMACEUTICAL FORM
Compressed medical gas (for medicinal use only).
Sweet smelling colourless non-irritating gas
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Nitrous oxide is indicated in adults and children for:
1.
General anaesthesia, usually as an adjuvant to other volatile or
intravenous anaesthetics.
2.
Analgesia (with oxygen) e.g. dentistry and obstetrics.
4.2.
DOSE AND METHOD OF ADMINISTRATION
PREMEDICATION
Premedication should be selected according to the needs of the
individual patient and in
consideration of the respiratory depressant effect of nitrous oxide.
GENERAL ANAESTHESIA
The use of nitrous oxide in general anaesthesia is mainly as an
adjuvant to other volatile inhalational
anaesthetics. Its use as the sole anaesthetic agent can lead to
hypoxia and inadequate depth of
anaesthesia.
In the average adult, nitrous oxide is administered by inhalation
through a suitable anaesthetic
apparatus in concentrations up to 70% with oxygen as the balance.
The concentration of nitrous oxide administered during maintenance of
anaesthesia must be
2
individualised depending upon the condition of the patient and
supplemental medications
administered.
The concentrations required in children must be individualised.
The inspired concentration of oxygen may need to be increased in
elderly patients or those with
pulmonary disease.
The efflux of nitrous oxide from the tissues via the lungs at the end
of anaesthesia may lead to
diffusion hypoxia if supplemental oxygen is not administered.
ANALGESIA
In the average adult