PROVIVE 1% propofol 500mg/50mL emulsion for injection vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

propofol, Quantity: 500 mg

Beszerezhető a:

Baxter Healthcare Pty Ltd

INN (nemzetközi neve):

Propofol

Gyógyszerészeti forma:

Injection, emulsion

Összetétel:

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

Az alkalmazás módja:

Intravenous

db csomag:

1 vial

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

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

Termék összefoglaló:

Visual Identification: White oil-in-water emulsion in a clear glass vial.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2005-05-06

Betegtájékoztató

Consumer Medicine Information – Provive 1%
CMI – 20190107
Page
1
of
4
PROVIVE 1 %
Propofol
Emulsion for Intravenous Injection or Infusion
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
Provive 1% 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.
IF YOU HAVE ANY CONCERNS
ABOUT BEING_ _ADMINISTERED
THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You
may
need to read it again.
WHAT PROVIVE 1% IS USED
FOR AND HOW IT WORKS
_General anaesthesia _
Provive 1 % 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. Provive
MCT- LCT 1 % 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.
Provive 1% can be used for
very short operations when
only one injection is needed.
Provive 1% can be used
throughout longer operations if
more is given as repeated
doses. Provive 1% 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 _
Provive 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.
This type of sedation may be
required during certain tests or
procedures.
Provive 1% can also be used in
intensive care wards for adults
and adolescents over 16 years
of age who are being ventilated
(on a breathing machine) to
ke

Termékjellemzők

Version 3.0 1 of 17
AUSTRALIAN PRODUCT INFORMATION – PROVIVE 1%
(PROPOFOL)
EMULSION
FOR
INTRAVENOUS
INJECTION, OR INFUSION
1
NAME OF THE MEDICINE
Propofol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Propofol (10 mg/mL).
List of excipients with known effect: Soya oil (100 mg/mL), Egg
lecithin (12 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Emulsion for intravenous injection, or infusion.
Provive 1% is a white, oil in water emulsion in a clear glass vial.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short acting intravenous anaesthetic agent suitable for induction and
maintenance of general anaesthesia
in adults and in children aged three years and older. Provive 1% 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.
Provive 1% may also be used in adults for sedation of ventilated
patients receiving intensive care. Provive
1% 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 Section 4.4 Special warnings and precautions
for use): Strict aseptic technique must
always be maintained during the handling of Provive 1%. Provive 1% is
for single use in one patient
only. Provive 1% can support the growth of microorganisms as it is not
an antimicrobially preserved product.
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). There have been reports in which failure to use aseptic
technique when handling propofol products was
Version 3.0 2 of 17
associated with microbial contamination of the product and with fever,
infection/ sepsis, other life-threatening
illness, and/or death.
ADULTS
_Induction of general a