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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propofol, Quantity: 500 mg

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Propofol

Pharmaceutical form:

Injection, emulsion

Composition:

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

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. PROVIVE MCT-LCT 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 MCT-LCT 1% may also be used in adults for sedation of ventilated patients receiving intensive care. PROVIVE MCT-LCT 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2010-03-05

Patient Information leaflet

Consumer Medicine Information - Provive MCT-LCT
CMI – 20190104
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PROVIVE MCT-LCT 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 MCT-LCT 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 MCT-LCT
1% IS USED FOR AND HOW IT
WORKS
_General anaesthesia _
Provive MCT-LCT 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 MCT-LCT 1% can be
used for very short operations
when only one injection is
needed. Provive MCT-LCT
1% can be used throughout
longer operations if more is
given as repeated doses.
Provive MCT-LCT 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 MCT-LCT 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 MCT-LCT 1% can
also be used in intensive care
wards for adults and
adolescents o

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION – PROVIVE MCT-LCT 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 (50 mg/mL) and 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 MCT-LCT 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 of
general anaesthesia in adults and in children
aged one month and older. Provive MCT-LCT 1% has no analgesic
properties.
Short acting anaesthetic agent suitable for maintenance of general
anaesthesia in adults and children aged 3 years
or older. Provive MCT-LCT 1% may also be used for maintenance of
general anaesthesia in children aged from 1
month to 3 years for procedures not exceeding 60 minutes unless
alternative anaesthetic agents should be avoided.
Provive MCT-LCT 1% may also be used in adults for sedation of
ventilated patients receiving intensive care.
Provive MCT-LCT 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 MCT-LCT 1%.
Provive MCT-LCT 1% is for
single use in one patient only. Provive MCT-LCT 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
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