DIPRIVAN propofol 1g/100mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propofol, Quantity: 10 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, emulsion

Composition:

Excipient Ingredients: egg lecithin; sodium hydroxide; disodium edetate; glycerol; water for injections; Soya Oil

Administration route:

Intravenous

Units in package:

1 x 100mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Diprivan is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and in children aged three years and older. Diprivan has no analgesic properties. Although the safety and efficacy of Diprivan in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. Diprivan may also be used in adults for sedation of ventilated patients receiving intensive care. Diprivan may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures. INDICATIONS AS AT 4 NOVEMBER 2004: Induction of General Anaesthesia in Children and Adults. DIPRIVAN is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older. Maintenance of General Anaesthesia in Children and Adults. DIPRIVAN is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older. DIPRIVAN may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided. DIPRIVAN has no analgesic properties. Sedation During Intensive Care in Adults. DIPRIVAN may also be used in adults for sedation of ventilated patients receiving intensive care. Conscious Sedation for Surgical and diagnostic Procedures in Adults. DIPRIVAN may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

Product summary:

Visual Identification: A white or almost white, homogenous emulsion, practically free from extraneous particulate contamination and large oil droplets. Slight creaming may be visible on prolonged standing.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store between 2 - 25 degrees celsius

Authorization status:

Licence status A

Authorization date:

2000-12-13

Patient Information leaflet

DIPRIVAN
1
DIPRIVAN
_propofol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME COMMON
QUESTIONS ABOUT DIPRIVAN. IT
DOES NOT CONTAIN ALL THE AVAILABLE
INFORMATION.
This leaflet does not replace advice
from your anaesthetist, surgeon,
doctor or pharmacist.
IF YOU HAVE ANY QUESTIONS, OR ARE
NOT SURE ABOUT ANYTHING, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION AFTER YOUR
OPERATION OR HOSPITAL STAY.
You may want to read it again later.
WHAT DIPRIVAN IS
USED FOR
GENERAL ANAESTHESIA
DIPRIVAN is used as a short-acting
general anaesthetic that can be given
into the blood stream through a
needle. It is used in adults, and
children aged one month and older.
A general anaesthetic is a medicine
which produces general anaesthesia.
This is the condition of heavy sleep
needed during surgery. Short-acting
means that a patient goes to sleep
quickly, usually within 30 seconds of
receiving DIPRIVAN, but then
wakes up quickly as it wears off. It
can be used for very short operations
when only one injection or dose is
needed. DIPRIVAN can be used for
longer operations if more is given as
repeat doses (maintenance
anaesthesia). It can be used to start
off an anaesthetic (induction
anaesthesia). This means that the
anaesthetist may change over to a gas
anaesthetic after you have gone to
sleep.
SEDATION
DIPRIVAN can also be given to
adults slowly in low doses if you
need to be sedated or sleepy, but do
not need the heavy sleep of
anaesthesia. Some people require
DIPRIVAN for this use during
special tests which may be called
procedures. After some operations it
is useful to keep a patient sedated
while they are in the "intensive care"
area. Your anaesthetist may need to
give you a pain-relieving or relaxing
medicine.
Every anaesthetic is different and
depends on the particular operation,
procedure or medical care you are
having. Your anaesthetist and
surgeon are trained to look after
every need you have while you are
asleep or having a procedure done.
He or she will decide which medicine
to use as

Summary of Product characteristics

Diprivan Product Information
1(18)
PAIN.000-154-879.3.0
AUSTRALIAN PRODUCT INFORMATION
DIPRIVAN (PROPOFOL) INJECTION
1.
NAME OF THE MEDICINE
Propofol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propofol 10mg/mL
Contains egg lecithin and soya oil. For the full list of excipients,
see section 6.1 List of
excipients.
3.
PHARMACEUTICAL FORM
A white or almost white, homogenous emulsion for injection or
infusion, practically
free from extraneous particulate contamination and large oil droplets.
Slight creaming
may be visible on prolonged standing.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS
DIPRIVAN is a short-acting intravenous anaesthetic agent suitable for
induction of
general anaesthesia in adults and children aged one month and older.
MAINTENANCE OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS
DIPRIVAN is a short-acting intravenous anaesthetic agent suitable for
maintenance
of general anaesthesia in adults and children aged 3 years and older.
DIPRIVAN may also be used for the maintenance of general anaesthesia
in children
aged from one month to 3 years for procedures not exceeding 60
minutes, unless
alternative anaesthetic agents should be avoided.
DIPRIVAN has no analgesic properties.
SEDATION DURING INTENSIVE CARE IN ADULTS
DIPRIVAN may also be used in adults for sedation of ventilated
patients receiving
intensive care.
CONSCIOUS SEDATION FOR SURGICAL AND DIAGNOSTIC PROCEDURES IN ADULTS
Diprivan Product Information
2(18)
PAIN.000-154-879.3.0
DIPRIVAN may also be used in adults for monitored conscious sedation
for surgical
and diagnostic procedures.
4.2
DOSE AND METHOD OF ADMINISTRATION
Strict aseptic technique must always be maintained during handling.
DIPRIVAN
injection is a single patient_ _ use only_ _ parenteral product which
contains 0.005%
disodium edetate to retard the rate of growth of micro-organisms in
the event of
accidental extrinsic contamination. However, DIPRIVAN injection can
still support
the growth of micro-organisms as it is not an