AIR LIQUIDE AUSTRALIA LIMITED Nitronox 50% Nitrous Oxide and 50% Oxygen Mixture Gas Medicinal

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

nitrous oxide, Quantity: 0.5 L/L; oxygen, Quantity: 0.5 L/L

可用日期:

Air Liquide Healthcare Pty Ltd

药物剂型:

Gas, medicinal

组成:

Excipient Ingredients:

给药途径:

Inhalation

每包单位数:

D size cylinder 1.7m3, E size cylinder 4.3m3, "C" size cylinder 0.5m3, G size cylinder 8.8m3

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

INDICATIONS AS AT 31 OCTOBER 2001: Nitrous oxide with oxygen (Nitronox) is indicated in adults and children for analgesia.

產品總結:

Visual Identification: colourless; Container Type: Gas Cylinder

授权状态:

Registered

授权日期:

1991-11-01

资料单张

AIR LIQUIDE HEALTHCARE
NITRONOX 50% NITROUS OXIDE AND 50% OXYGEN MIXTURE GAS
MEDICINAL
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Nitronox. 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 Nitronox against the
benefits they expect it will have
for you.
If you have any concerns
about using Nitronox, ask your
doctor or dentist.
Keep this leaflet with you, you
may want to read it again.
WHAT NITRONOX IS USED FOR
Nitronox is a gas mixture of
50% Medical Nitrous Oxide and
50% Medical Oxygen used for
general anaesthesia.
Nitronox works by relieving
pain for certain procedures.
Your doctor may prescribe
Nitronox for another purpose.
Ask your doctor if you have any
questions about why Nitronox
has been prescribed for you.
This medicine is available only
with a doctor's prescription.
BEFORE YOU USE NITRONOX
_WHEN YOU MUST NOT USE IT _
Do not use Nitronox 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 Nitronox (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. You are intoxicated or
heavily sedated
Do not use Nitronox if the
cylinder is damaged or shows
signs of tampering or it has
degraded.
_BEFORE YOU START TO USE IT _
You must tell your doctor or
dentist if:
1. You are allergic to any other
medicines, foods, dyes or
preservatives.
2. You have had a reaction to
nitrous oxide or any other
general anaesthetic or pain
relief medication in the past.
3. You have had a general
anaesthetic or surgery in the
past.
4. You have or have had any
other health p

产品特点

1
AUSTRALIAN PRODUCT INFORMATION
NITRONOX
® (50% NITROUS OXIDE/50% OXYGEN) – GAS MEDICINAL
1
NAME OF THE MEDICINE
Nitrous Oxide and Oxygen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The specifications for each of the main components are presented
separately
_Nitrous Oxide _
Complies with the requirements of the current European Pharmacopoeia
monograph for
Nitrous oxide, N
2
O.
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/NO
2
)
2ppm v/v maximum
Water (vapour)
67 ppm v/v maximum
_Oxygen _
Complies with the requirements of the current European Pharmacopoeia
monograph for
Oxygen, Oxygen, O
2
.
Oxygen
99.5% v/v minimum
Carbon dioxide
300 ppm v/v maximum
Carbon monoxide
5 ppm v/v maximum
Water (vapour)
67 ppm v/v maximum
Nitronox is a homogeneous gas mixture of oxygen and nitrous oxide in
equal volumetric
proportions.
Nitrous oxide is the active ingredient.
Nitrous oxide is a sweet smelling colourless non-irritating gas.
Oxygen is a colourless,
odourless and tasteless gas. Nitrous oxide is not very soluble in
water and has a low
solubility in blood and tissues.
3
PHARMACEUTICAL FORM
Compressed colourless medical gas mixture (for medicinal use only).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Nitrous oxide with oxygen (Nitronox
®
) is indicated in adults and children for analgesia.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Nitronox is self-administered and inhaled via a demand valve through a
face mask or
mouthpiece. The gas is breathed in by the patient on demand and
absorbed through the
lungs.
Nitronox should only be administered by medical personnel trained in
the appropriate
techniques and in an adequate environment.
Cylinders should only be used in conjunction with special Nitronox gas
pressure
regulators and demand valves.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to nitrous oxide or any other component in the gas is
a contraindication.
Nitrous oxide should not be used with any condition where air is
entrapped within a body
a