Propofol 1% (10 mg/ml) emulsion for injection/infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Propofol

Dostupné s:

Fresenius Kabi Deutschland GmbH

ATC kód:

N01AX; N01AX10

INN (Mezinárodní Name):

Propofol

Dávkování:

1 percent weight/volume

Léková forma:

Emulsion for injection/infusion

Druh předpisu:

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

Terapeutické oblasti:

Other general anesthetics; propofol

Stav Autorizace:

Marketed

Datum autorizace:

2005-04-22

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL 1% (10 MG/ML) EMULSION FOR INJECTION/INFUSION
Propofol
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 Propofol 1% is and what it is used for
2.
What you need to know before you are given Propofol 1%
3.
How to use Propofol 1%
4.
Possible side effects
5.
How to store Propofol 1%
6.
Contents of the pack and other information
1. WHAT PROPOFOL 1% IS AND WHAT IT IS USED FOR
Propofol 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).
PROPOFOL 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 PROPOFOL 1%
DO NOT USE PROPOFOL 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 Propofol
1% and if any of the subsequent
mentioned applies to you or applied to you in the past.
You should not receive Propofol 1% or only under extr

Charakteristika produktu

Health Products Regulatory Authority
26 January 2024
CRN00DRJM
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol 1% (10 mg/ml) emulsion for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml emulsion contains 10 mg propofol.
Each 20 ml ampoule contains 200 mg propofol.
Each 20 ml vial contains 200 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 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
Propofol 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
Propofol 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 Propofol 1%
should not be administered by the same person
conducting the surgical or diagnostic procedure.
The dose of Propofol 1% should be individualised based on the response
of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to
Propofol 1%.
POSOLOGY
_ _
GENERAL ANAESTHESIA IN ADULTS