HOSPIRA PROPOFOL INJECTION propofol 500mg/50mL emulsion for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
21-05-2020
Summary of Product characteristics
(SPC)
10-12-2018
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
propofol
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
Propofol
Authorization status:
Registered
Patient Information leaflet
Hospira
TM
Propofol Injection CMI
Page 1
HOSPIRA™ PROPOFOL INJECTION
Propofol _(pro-po-fole)_
CONSUMER MEDICINE INFORMATION
_Date of dispensing_
_Consumer name_
_pharmacy name_
_Consumer address_
_pharmacy address_
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Hospira
Propofol Injection. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
anaesthetist.
All medicines have risks and
benefits. Your doctor or
anaesthetist has weighed the
risks of you being given propofol
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR ANAESTHETIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HOSPIRA
PROPOFOL INJECTION IS
USED FOR
_GENERAL ANAESTHESIA_
Hospira Propofol Injection is used
as a short-acting general
anaesthetic in adults, and children
aged 1 month or older.
A general anaesthetic is a
medicine which produces general
anaesthesia. This is the condition
of heavy sleep needed during
surgery. Propofol is short-acting,
which means that patients go to
sleep quickly, usually within 30
seconds of receiving propofol, but
then wake up quickly as it wears
off.
Propofol can be used for very
short operations when only one
injection is needed.
Propofol can be used throughout
longer operations if more is given
as repeated doses.
Propofol can also be used to start
off anaesthesia (induction
anaesthesia). This means the
anaesthetist may change over to
another anaesthetic once sleep is
induced.
_SEDATION_
Propofol can be given to adults if
they need to be sedated (calm) or
sleepy, but do not need the heavy
sleep of anaesthesia. This type of
sedation may be required during
certain tests or procedures.
Propofol can also be used in
intensive care wards for adults
who are being ventilated (on a
breathing machine) to keep them
sedated (calm).
ASK YOUR DOCTOR OR ANAESTHETIST
IF YOU HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor or anaest
Read the complete document
Summary of Product characteristics
Version 2.0
Supersedes: Version 1.0
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
HOSPIRA™ PROPOFOL INJECTION (PROPOFOL)
1.
NAME OF THE MEDICINE
Propofol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hospira™ Propofol Injection contains 10 mg propofol per 1 mL.
EXCIPIENT(S) WITH KNOWN EFFECT
- Egg lecithin
- Soya Oil
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Hospira™ Propofol Injection is a white to slight off-white, oil in
water emulsion of pH
6.0 to 8.5 for intravenous injection._ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS
Hospira™ Propofol Injection 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
Hospira™ Propofol Injection is a short-acting intravenous
anaesthetic agent suitable for
maintenance of general anaesthesia in adults and children aged 3 years
and older.
Hospira™ Propofol Injection 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.
Hospira™ Propofol Injection has no analgesic properties.
SEDATION DURING INTENSIVE CARE IN ADULTS
Version 2.0
Supersedes: Version 1.0
Page 2 of 18
Hospira™ Propofol Injection may also be used in adults for sedation
of ventilated patients
receiving intensive care.
CONSCIOUS SEDATION FOR SURGICAL AND DIAGNOSTIC PROCEDURES IN ADULTS
Hospira™ Propofol Injection may also be used in adults for monitored
conscious sedation
for surgical and diagnostic procedures.
4.2 DOSE AND METHOD OF ADMINISTRATION
_ASEPTIC TECHNIQUE (_see also_ _SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE_) _
Strict aseptic technique must always be maintained during handling.
Hospira™ Propofol
Injection is for single use in one patient only. Hospira™ Propofol
Injection
Read the complete document
