FRESOFOL 1% propofol 500mg/50mL injection vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

propofol, Quantity: 10 mg/mL

Saatavilla:

Fresenius Kabi Australia Pty Ltd

Lääkemuoto:

Injection, emulsion

Koostumus:

Excipient Ingredients: Soya Oil; water for injections; egg lecithin; sodium hydroxide; oleic acid; glycerol

Antoreitti:

Intravenous

Kpl paketissa:

1 vial

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

FRESOFOL 1% is a short-acting intravenous anaesthetic agent suitable for the induction and maintenance of general anaesthesia in adults and children aged three years and older. FRESOFOL 1% has no analgesic properties. Although the safety and efficacy of FRESOFOL 1% in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. FRESOFOL 1% may also be used in adults for the sedation of ventilated patients receiving intensive care, and for monitored conscious sedation for surgical and diagnostic procedures.

Tuoteyhteenveto:

Visual Identification: white, homogenous emulsion; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2004-11-24

Pakkausseloste

Mar, 2016
CMI FOR FRESOFOL
Filename: FreCMI160316-clean
Page 1 of 3
Change: Address change
FRESOFOL 1%
Propofol 1% w/v
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common questions about Fresofol
1%.
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
Fresofol
1%
against
the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR ANAESTHETIST. KEEP THIS
LEAFLET. YOU MAY NEED TO READ IT
AGAIN.
WHAT IS FRESOFOL 1%
USED FOR
GENERAL ANAESTHESIA
Fresofol
1%
contains
propofol,
which
is
used
as
a
short-acting
general anaesthetic in adults and
children aged 3 years or older.
Fresofol
1%
is
a
general
anaesthetic agent that puts you in
heavy
sleep
which
is
needed
during
surgery.
Fresofol
1%
is
short-acting
which
means
that
once you are given Fresofol 1% it
will
put
you
to
sleep
quickly,
usually within 30 seconds. You
will wake up quickly as the effect
wears off.
If
you
are
undergoing
surgery,
Fresofol 1% can be used to put
you
to
sleep,
and
then
your
anaesthetist
may
give
you
more
Fresofol 1% or he/she may change
over to a gas anaesthetic to keep
you asleep during surgery.
SEDATION
Fresofol 1% 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. Fresofol 1% can also
be
given
slowly
(by
a
special
pump) if you need to be sedated.
This
may
be
necessary
during
special tests or procedures or after
an operation. Your anaesthetist or
doctor
may need
to give
you a
pain-relieving or relaxing medicine
as well.
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 another reason.
Fresofol 1% is not addictive.
Fresofol 1% is available only with a
doctor�

Valmisteyhteenveto

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
FRESOFOL
®
1 % (PROPOFOL)
1 NAME OF MEDICINE
Propofol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of Fresofol 1% injection contains propofol 10 mg. It also
contains; soya oil and
egg lecithin.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Propofol is a clear colourless to straw yellow liquid with a typical
odour. Fresofol 1%
injection is a white, isotonic (oil-in water) emulsion and is designed
for intravenous
injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fresofol 1% is a short-acting intravenous anaesthetic agent suitable
for the induction
of general anaesthesia in adults and children aged three years and
older. Fresofol
1% has no analgesic properties.
Although safety and efficacy of Fresofol 1% in paediatric day surgery
have not been
demonstrated, it may be a useful agent in this setting and its use
should not be
precluded.
Fresofol 1% may also be used in adults for the sedation of ventilated
patients
receiving intensive care.
Fresofol 1% may also be used in adults for monitored conscious
sedation for surgical
and diagnostic procedures.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage and Administration (see also Aseptic Technique)
Strict aseptic technique must always be maintained during handling.
Fresofol 1%
injection is a single patient use only parenteral product which does
not contain any
antimicrobial preservative. Accordingly, strict aseptic technique must
still be adhered
to. Do not use if contamination is suspected. Discard unused portions
as directed
within
the
required
time
limits
(see
section
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS FOR USE- Aseptic Technique and 6.3 SHELF LIFE). There have
been reports in which failure to use aseptic technique when handling
Fresofol 1%
injection was associated with microbial contamination of the product
and with fever,
infection/sepsis, other life-threatening illness, and/or death.
ADULTS
a) Induction of general anaesthesia
Page 2 of 17
Fresofol 1% may be used to in