PROPOFOL-LIPURO 2% propofol 1000 mg/50 mL emulsion for injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propofol, Quantity: 20 mg/mL

Available from:

B Braun Australia Pty Ltd

INN (International Name):

Propofol

Pharmaceutical form:

Injection, emulsion

Composition:

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

Administration route:

Intravenous

Units in package:

10 x 100 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Because of the difficulty in titrating small volumes, Propofol-Lipuro 2% should not be used in children aged from one month to 3 years.,Induction of General Anaesthesia in Children and Adults Propofol-Lipuro 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 Propofol-Lipuro is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older.,Propofol-Lipuro 1% may also be used for 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.,Propofol has no analgesic properties.,Use for Sedation During Intensive Care in Adults Propofol-Lipuro may also be used in patients >16 years for sedation of ventilated patients receiving intensive care.,Conscious Sedation for Surgical and diagnostic Procedures Propofol-Lipuro may also be used for monitored conscious sedation for surgical and diagnostic procedures in,? Propofol-Lipuro 1%: adults and children aged one month and older. ? Propofol-Lipuro 2%: adults and children aged 3 years and older.

Product summary:

Visual Identification: Milky white oil-in-water emulsion in a colourless glass infusion bottle, sealed with a grey rubber stopper and aluminium seal with red polypropylene flip-off insert; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-03-10

Patient Information leaflet

B.Braun Australia Pty Ltd
Page 1
CONSUMER MEDICINE INFORMATION
PROPOFOL-LIPURO 1% AND 2%
1.
What is in this leaflet
This leaflet contains some common questions about Propofol-Lipuro.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist
All medicines have risks and benefits. Your doctor or pharmacist has
weighed the risk of
you taking this medicine against the benefits they expect it will have
for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
2.
What is Propofol-Lipuro used for?
It is a short-acting sleep inducing medicinal product used to start
and sustain a general
anaesthesia.
It is used to induce sleep or lower your level of consciousness (as a
sedative) during intensive
care or during diagnostic or surgical procedures.
3.
Before you are given Propofol-Lipuro
_WHEN YOU MUST NOT BE GIVEN PROPOFOL-LIPURO _
_ _
Do not use Propofol-Lipuro:

if you are allergic (hypersensitive) to Propofol or any of the other
ingredients of
Propofol-Lipuro

if you are allergic (hypersensitive) to soya or peanut
_TAKE SPECIAL CARE WITH PROPOFOL-LIPURO IF: _

you have a disorder in which your body does not handle fat properly

you have any other health problems which require much caution in the
use of fat
emulsions

you are very overweight

your blood volume is too low (hypovolaemia)

you are very weak or have heart, circulatory, kidney or liver problems

you have high pressure within in the skull and low blood pressure in
the arteries

you have problems with your breathing

you have epilepsy

you are undergoing some procedures where spontaneous movements are
particularly,
undesirable.
Please tell your doctor if you have one of these diseases or
conditions.
Do not give Propofol-Lipuro in children of one month of age or younger
as a general anaesthetic.
B.Braun Australia Pty Ltd
Page 2
Do not give Propofol-Lipuro 2% in children under 3 years of age.
Do not give Pro

Summary of Product characteristics

Version 2.1
Supersedes: Version 2.0
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PROPOFOL-LIPURO 1% AND 2% (PROPOFOL)
1.
NAME OF MEDICINE
Propofol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propofol-Lipuro contains:
_per 1 mL_
_per 20 mL ampoule or vial_
_per 50 mL bottle_
_per 100 mL bottle_
_Propofol- _
_Lipuro 1%_
_10 mg _
_propofol_
_200 mg propofol_
_500 mg propofol_
_1000 mg propofol_
_Propofol- _
_Lipuro 2%_
_20 mg _
_propofol_
_ _
_ _
_-_
_1000 mg propofol_
_-_
Contains egg lecithin and soya oil. For the full list of excipients,
see section 6.1 List of
excipients.
3.
PHARMACEUTICAL FORM
Sterile, milky white, isotonic, oil in water emulsion for intravenous
infusion or
injection
containing 10 mg propofol per 1 mL (Propofol-Lipuro 1%) or 20 mg
propofol
per 1 mL (Propofol-Lipuro 2%).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Because of the difficulty in titrating small volumes, Propofol-Lipuro
2% should not
be
used in children aged from one month to 3 years.
INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS
Propofol-Lipuro 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
Propofol-Lipuro is a short acting intravenous anaesthetic agent
suitable for
maintenance of
general anaesthesia in adults and children aged 3 years and older.
Propofol-Lipuro 1% may also be used for 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.
Propofol has no analgesic properties.
Version 2.1
Supersedes: Version 2.0
Page 2 of 20
SEDATION DURING INTENSIVE CARE IN ADULTS
Propofol-Lipuro may also be used in patients >16 years for sedation of
ventilated patients
receiving intensive care.
CONSCIOUS SEDATION FOR SURGICAL AND DIAGNOSTIC PROCEDURES
Propofol-Lipuro
may also
be
used
for
monitored
conscious sedation for surgical
and
diagnostic procedures in
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