PROPOFOL SANDOZ propofol 200mg/20mL emulsion for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propofol

Available from:

Sandoz Pty Ltd

INN (International Name):

Propofol

Authorization status:

Registered

Patient Information leaflet

PROPOFOL SANDOZ
_Propofol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine.
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 Sandoz 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 AFTER YOUR
OPERATION OR HOSPITAL STAY.
You may need to read it again.
WHAT PROPOFOL SANDOZ
IS USED FOR
_GENERAL ANAESTHESIA_
Propofol Sandoz contains propofol,
which is used as a short-acting
general anaesthetic in adults, and
children aged 3 years or older.
A general anaesthetic is a medicine
which produces general anaesthesia.
Propofol Sandoz is short-acting,
which means that patients go to sleep
quickly, usually within 30 seconds of
receiving the medication, but then
wake up quickly as it wears off.
Propofol Sandoz can be used for very
short operations when only one
injection is needed.
Propofol Sandoz can be used
throughout longer operations if more
is given as repeated doses
(maintenance anaesthesia).
Propofol Sandoz can also be used to
start off an anaesthetic (induction
anaesthesia). This means the
anaesthetist may change over to a gas
anaesthetic once sleep is induced.
_SEDATION_
Propofol Sandoz can be given to
adults and adolescents over 16 years
of age in lower doses if they need to
be sedated or sleepy, but do not need
the heavy sleep of anaesthesia. This
type of sedation may be required
during certain tests or procedures.
Propofol Sandoz can also be given in
intensive care wards for adults and
adolescents over 16 years of age who
are being ventilated (on a breathing
machine) to keep them sedated.
Ask your doctor or anaesthetist if you
have any questions about why this
medicine has been prescribed for
you. Your doctor or anaesthetist may
have prescribed it for

Summary of Product characteristics

200205-Propofol Sandoz-pi
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
PROPOFOL SANDOZ
®
(PROPOFOL)
1.
NAME OF THE MEDICINE
Propofol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of Propofol Sandoz contains 10 mg of propofol.
List of excipients with known effect: egg lecithin, soya oil.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Injection, emulsion for (intravenous infusion).
Propofol Sandoz is a white, oil in water emulsion in a clear glass
vial.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Propofol Sandoz 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.
Propofol Sandoz has no analgesic properties.
Although the safety and efficacy of propofol in paediatric day surgery
have not been
demonstrated, it may be a useful agent in this setting and its use
should not be precluded.
Propofol Sandoz may also be used in adults for sedation of ventilated
patients receiving
intensive care.
Propofol Sandoz may also be used in adults for monitored conscious
sedation for surgical and
diagnostic procedures.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
_INDUCTION OF GENERAL ANAESTHESIA _
Propofol Sandoz may be used to induce anaesthesia by slow bolus
injection or infusion. In
unpremedicated and in premedicated patients, it is recommended that
Propofol Sandoz should
be titrated (approximately 4 mL (40 mg) every ten seconds in an
average healthy adult) against
the response of the patient until the clinical signs show the onset of
anaesthesia. Most adult
patients aged less than 55 years are likely to require Propofol Sandoz
at 2.0 to 2.5 mg/kg. In
elderly patients, requirements will be generally less (see Elderly
patients, below). In general,
slower rates of infusion at induction results in a lower induction
dose requirement and greater
haemodynamic stability. In patients of ASA grades III and IV, lower
rates of administration
should be used (approxi