Propofol-Lipuro 0.5% (5 mg/ml) emulsion for injection or infusion

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Propofol

थमां उपलब्ध:

B. Braun Melsungen AG

ए.टी.सी कोड:

N01AX; N01AX10

INN (इंटरनेशनल नाम):

Propofol

डोज़:

0.5 percent

फार्मास्यूटिकल फॉर्म:

Emulsion for injection/infusion

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Other general anesthetics; propofol

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2008-07-21

सूचना पत्रक

Propofol-Lipuro 0.5%_0918_PIL_14Mar22_clean2011-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL-LIPURO 0.5% (5 MG/ML) EMULSION FOR INJECTION OR INFUSION
Propofol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
●
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Propofol-Lipuro is and what it is used for
2.
What you need to know before you use Propofol-Lipuro
3.
How to use Propofol-Lipuro
4.
Possible side effects
5.
How to store Propofol-Lipuro
6.
Contents of the pack and other information
1.
WHAT PROPOFOL-
LIPURO IS AND WHAT IT IS USED FOR
Propofol-Lipuro 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).
Propofol is used to
●
induce general anaesthesia in
ADULTS
and
CHILDREN > 1 MONTH
●
sedate adult patients during diagnostic and surgical procedures for a
short time, alone or in combination
with local or regional anaesthesia
●
induce sedation in
ADULTS
and
CHILDREN > 1 MONTH
during diagnostic and surgical procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROPOFOL-LIPURO
DO NOT USE PROPOFOL-LIPURO
●
if you are allergic to propofol, soya, peanut or any of the other
ingredients of this medicine (listed in
section 6).
●
for maintenance of general anaesthesia or of sedation for diagnostic
and surgical procedures in children
●
for sedation during intensive care.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before receiving Propofol-Lipuro.
Special care has to be taken
●
if you have serious head injuries,
●
if you have a mitochondri

उत्पाद विशेषताएं

Health Products Regulatory Authority
18 May 2022
CRN00CHWM
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol-Lipuro 0.5% (5 mg/ml) emulsion for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml emulsion for injection or infusion contains 5 mg propofol.
1 ampoule with 20 ml contains 100 mg propofol
Excipients with known effect
1 ml of emulsion contains
Soya-bean oil refined 50 mg
For the 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 0.5% (5 mg/ml) is a short-acting intravenous general
anaesthetic indicated for

induction of general anaesthesia in adults and children > 1 month

induction of sedation for diagnostic and surgical procedures in adults
and children > 1 month

short term sedation for diagnostic and surgical procedures, alone or
in combination with local or regional
anaesthesia, in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_GENERAL INSTRUCTIONS_
Propofol-Lipuro 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 oximeter) 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 should not be given
by the same person that carries out the surgical or diagnostic
procedure.
Propofol-Lipuro 0.5% (5 mg/ml) is intended for use in children,
adolescents and adults, especially the pain-sensitive ones,
because of the lower pain on injection compared to higher strengths.
Supplementary analgesic medicinal products are generally required in
addition to Propofol-Lipuro
Posology
Propofol-Lipuro is given intravenously. The dosage is adjusted
in