FRESENIUS PROPOVEN 1 %w/v Emulsion for Inj/Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
04-07-2017
Summary of Product characteristics
(SPC)
04-07-2017
Active ingredient:
PROPOFOL
Available from:
Fresenius Kabi Limited
ATC code:
N01AX10
INN (International Name):
PROPOFOL
Dosage:
1 %w/v
Pharmaceutical form:
Emulsion for Inj/Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other general anesthetics
Authorization status:
Authorised
Authorization date:
2005-04-22
Patient Information leaflet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it
again.
-
If you have any further questions, ask your
doctor, pharmacist or nurse.
-
If you get any side effects, talk to your doctor,
pharmacist
or
nurse.
This
includes
any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fresenius Propoven 1% is and what it is
used for
2.
What you need to know before you are given
Fresenius Propoven 1%
3.
How to use Fresenius Propoven 1%
4.
Possible side effects
5.
How to store Fresenius Propoven 1%
6.
Contents of the pack and other information
1. WHAT FRESENIUS PROPOVEN 1% IS AND WHAT IT
IS USED FOR
Fresenius Propoven 1% belongs to a group of
medicines called ‘general anaesthetics’. General
anaesthetics are used to cause unconsciousness
(sleep)
so
that
surgical
operations
or
other
procedures can be performed. They can also be
used to sedate you (so that you are sleepy but not
completely asleep).
FRESENIUS PROPOVEN 1% EMULSION FOR INJECTION
OR INFUSION IS USED TO:
•
induce
and
maintain
general
anaesthesia
in adults, adolescents and children older than 1
month.
•
sedate patients older than 16 years of age
receiving artificial respiration in intensive care.
•
sedate adults, adolescents and children older
than 1 month during diagnostic and surgical
procedures, alone or in combination with local
or regional anaesthesia.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
FRESENIUS PROPOVEN 1%
DO NOT USE FRESENIUS PROPOVEN 1%
-
if you are allergic to propofol, soya, peanut or
any of the other ingredients of this medicine
(listed in section 6).
-
in patients of 16 years of age or younger for
sedation in intensive care.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you
are given Fresenius Propoven 1% and if any of the
subsequent mentioned applies to you or applied to
you in the past.
You
should
not
receive
Fresenius
Propoven
1%, or only under e
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fresenius Propoven 1%_,_ emulsion for injection or infusion, ampoule.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml emulsion contains 10 mg propofol.
Each 20 ml ampoule contains 200 mg propofol.
Excipients with known effect:
Each ml emulsion contains:
soya-bean oil, refined
50 mg
sodium
max. 0.06 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection or infusion.
White oil-in-water emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fresenius Propoven 1% emulsion for injection or infusion is a
short-acting intravenous general anaesthetic for
induction and maintenance of general anaesthesia in adults,
adolescents and children > 1 month sedation for diagnostic
and surgical procedures, alone or in combination with local or
regional anaesthesia in adults, adolescents and children >
1 month sedation of ventilated patients > 16 years of age in the
intensive care unit
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fresenius Propoven 1% must only be given in hospitals or adequately
equipped day therapy units by physicians trained
in anaesthesia or in the care of patients in intensive care.
Circulatory and respiratory functions should be constantly monitored
(e.g.
ECG,
pulse oxymetry) and facilities for
maintenance of patient airways, artificial ventilation, and other
resuscitation facilities should be immediately available
at all times.
For sedation during surgical
and diagnostic procedures Fresenius Propoven 1% should not
be administered by the
same person conducting the surgical or diagnostic procedure.
The dose of Fresenius Propoven 1% should be individualised based on
the response of the patient and premedications
used.
Supplementary analgesic agents are generally required in addition to
Fresenius Propoven 1% .
POSOLOGY
GENERAL ANAESTHESIA IN ADULTS
Induction of anaesthesia:
H
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A
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T
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T
S
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G
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A
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A
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