PROPOFOL-LIPURO 2%

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROPOFOL

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

N01AX10

Pharmaceutical form:

EMULSION FOR INJECTION OR INFUSION

Composition:

PROPOFOL 20 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic group:

PROPOFOL

Therapeutic area:

PROPOFOL

Therapeutic indications:

Propofol-Lipuro 2% is a short-acting intravenous general anaesthetic for● induction and maintenance of general anaesthesia in adults and children > 3 years● sedation of ventilated patients >16 years of age in the intensive care unit● sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 3 years.

Authorization date:

2014-09-30

Patient Information leaflet

אפורל ןולעב )תוחיטב עדימ( הרמחה לע
העדוה ןכדועמ(
.102.50 ) :ךיראת
_13/03/17_ םושירה רפסמו תילגנאב רישכת םש
:
00
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36713
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11
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646
PROPOFOL LIPURO 2% םושירה לעב םש :
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
! דבלב תורמחהה טרפמ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.2 POSOLOGY AND
METHOD OF
ADMINISTRATION
_METHOD AND DURATION OF ADMINISTRATION _
●
_Method of administration _
Intravenous use
Propofol-Lipuro 1% is administered intravenously
by injection or continuous infusion either undiluted
or diluted with 5 % w/v glucose solution or 0.9 %
w/v sodium chloride solution as well as in a 0.18 %
w/v sodium chloride and 4 % w/v glucose (see also
section 6.6).
Containers should be shaken before use.
Before use, the neck of the ampoule or the surface
of the rubber stopper of the vial should be cleaned
with medicinal alcohol (spray or swabs). After use,
tapped containers must be discarded.
Infusion of undiluted Propofol-Lipuro 1%
When administering Propofol-Lipuro 1% by
continuous infusion, it is recommended that
burettes, drop counters, syringe pumps or
volumetric infusion pumps, should always be used
to control the infusion rates.
_METHOD AND DURATION OF ADMINISTRATION _
●
_Method of administration _
Intravenous use
Propofol-Lipuro 1% is administered
intravenously by injection or continuous
infusion either undiluted or diluted with 5 %
w/v glucose solution or 0.9 % w/v sodium
chloride solution as well as in a 0.18 % w/v
sodium chloride and 4 % w/v glucose (see also
section 6.6).
Containers should be shaken before use.
Before use, the neck of the ampoule or the
surface of the rubber stopper of the vial should
be cleaned with medicinal alcohol (spray or
swabs). After use, tapped containers must be
discarded.
Propofol-Lipuro 10 mg/ml contains no
antimicrobial preservatives and supports
growth of microorganisms. Therefore,
Propofol-Lipuro 10 mg/ml is to be drawn up
a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
Name of the Medicinal Product
Propofol-Lipuro 2%
2
Qualitative and Quantitative Composition
Propofol 20 mg/ml
Excipient(s) with known effect:
Soya-bean oil, refined
For a full list of excipients, see section 6.1.
3
Pharmaceutical Form
Emulsion for injection or infusion
White milky oil-in-water emulsion
4
Clinical Particulars
4.1
Therapeutic indications
Propofol-Lipuro 2% is a short-acting intravenous general anaesthetic
for
●
induction and maintenance of general anaesthesia in adults and
children > 3 years
●
sedation of ventilated patients >16 years of age in the intensive care
unit
●
sedation for diagnostic and surgical procedures, alone or in
combination with local or regional
anaesthesia in adults and children > 3 years.
4.2
Posology and method of administration
GENERAL INSTRUCTIONS
Propofol-Lipuro 2% must only be given in hospitals or adequately
equipped day therapy units by phy-
sicians trained in anaesthesia or in the care of patients in intensive
care. Circulatory and respiratory
functions should be constantly monitored (e.g. ECG, pulse-oxymeter)
and facilities for maintenance of
patent airways, artificial ventilation, and other resuscitation
facilities should be immediately available
at all times. For sedation during surgical or diagnostic procedures
Propofol-Lipuro 2% should not be
given by the same person that carries out the surgical or diagnostic
procedure.
Supplementary analgesic medicinal products are generally required in
addition to Propofol-Lipuro 2%
POSOLOGY
Propofol-Lipuro 2% is given intravenously. The dosage is adjusted
individually according to the pa-
tient’s response.
●
_General anaesthesia in adults _
_Induction of anaesthesia: _
For induction of anaesthesia Propofol-Lipuro 2% should be titrated (20
–
40 mg propofol every 10
sec
onds) against the patient’s response until the clinical signs show
the onset of anaesthesia. Most
adult patients younger than 55 years are likely to require 1.5 to 2.5
mg/kg body weight.
In patients over this age