BOC GASES ENTONOX OXYGEN 50%v/v and NITROUS OXIDE 50%v/v MIXTURE, Gas Medicinal

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

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

Mevcut itibaren:

BOC Limited

INN (International Adı):

Nitrous oxide,Oxygen

Farmasötik formu:

Gas, medicinal

Kompozisyon:

Excipient Ingredients:

Uygulama yolu:

Inhalation

Paketteki üniteler:

various

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

INDICATIONS AS AT 1 NOVEMBER 2001: "Nitrous oxide with oxygen (Entonox) is indicated in adults and children for analgesia." This approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application.

Ürün özeti:

Visual Identification: Colourless gas; Container Type: Gas Cylinder

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1992-01-02

Bilgilendirme broşürü

D:\My Documents\Regulatory Affairs Files\Medical Gases\CMI's TGA
Approved\CMI - 27.03.08.doc
1
ENTONOX



50% v/v Nitrous oxide, N
2
O and 50% v/v Oxygen, O
2
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Entonox. It does
not
contain
all
the
available
information.
It does not take the place of talking
to
your
doctor,,
anaesthetist
or
appropriate healthcare professional.
All
medicines
have
risks
and
benefits. Your doctor or healthcare
professional has weighed the risks
of you
using Entonox against the
benefits they expect it will have for
you.
If
you
have
any
concerns
about
using Entonox, ask your doctor.
Keep this leaflet with you, you may
want to read it again.
WHAT ENTONOX IS USED
FOR
Entonox is a nominal gas mixture of
50% nitrous oxide and 50% oxygen
used for pain relief.
It
is
usually
given
by
a
doctor,
anaesthetist,
dentist,
ambulance
officer
or
nurse
via
a
mask
or
mouthpiece in which you breathe in
the gas.
Entonox works by relieving pain for
certain procedures.
Your doctor may prescribe Entonox
for another purpose. Ask your doctor
if you have any questions about why
Entonox
has
been
prescribed
for
you.
This medicine is available only with a
doctor's prescription.
BEFORE YOU USE ENTONOX
_WHEN YOU MUST NOT USE IT_
DO NOT USE ENTONOX IF:
1.
YOU
HAVE
AN
ALLERGY
TO
ENTONOX OR NITROUS OXIDE OR ANY
OTHER
GAS
COMPONENT
OR
HAVE
HAD
AN ALLERGIC REACTION IN THE
PAST.
2. YOU HAVE EMPHYSEMA, CHRONIC
BRONCHITIS
OR
IF
IT
IS
FOR
A
PREMATURE INFANT.
3. 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.
4. YOU HAVE BEEN USING IT FOR A
PROLONGED PERIOD WITHOUT PROPER
MONITORING OF YOUR BLOOD.
Do not use Entonox if the cylinder is
damaged
or
shows
signs
of
tampering or it has degraded.
5. YOU ARE SMOKING OR THERE ARE
NAKED FLAMES NEARBY. YOU MUST
NOT
SMOKE OR LIGHT ANY FLAMES
WHILST

Ürün özellikleri

1
AUSTRALIAN PRODUCT INFORMATION –
ENTONOX (NITROUS OXIDE / OXYGEN)
1.
NAME OF THE MEDICINE
Nitrous oxide and Oxygen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrous oxide
50% v/v
Oxygen
50% v/v
Entonox is a homogenous gas mixture of oxygen and nitrous oxide in
equal volumetric proportions.
Nitrous oxide is the active ingredient.
There are no excipients.
3.
PHARMACEUTICAL FORM
Compressed medical gas mixture (for medicinal use only).
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nitrous oxide with oxygen (Entonox) is indicated in adults and
children for analgesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Entonox should only be administered by medical personnel trained in
the appropriate techniques and
in an adequate environment with access to adequate resuscitation
equipment.
Cylinders should only be used in conjunction with special Entonox gas
pressure regulators and demand
valves.
Entonox 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.
In dentistry, the use of a double mask is recommended, alternatively,
a mask with adequate
scavenging/ventilation should be used.
4.3
CONTRAINDICATIONS
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 and where
its expansion might be dangerous, such as: the presence of
intracranial air; artificial, traumatic or
spontaneous pneumothorax; pneumopericardium; air (or gas) embolism;
severe head trauma;
decompression sickness; following a recent dive; severe bullous
emphysema; during myringoplasty;
occluded middle ear; cysts; gross abdominal distension; maxillofacial
injuries, following
cardiopulmonary bypass or air encephalograp