Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or infusion, vial

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propofol

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

N01AX; N01AX10

INN (International Name):

Propofol

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Emulsion for injection/infusion

Therapeutic area:

Other general anesthetics; propofol

Authorization status:

Not marketed

Authorization date:

1998-05-01

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL 1 % (10 MG/1 ML) FRESENIUS EMULSION FOR INJECTION OR 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 Fresenius is and what it is used for
2.
What you need to know before you are given Propofol Fresenius
3.
How to use Propofol Fresenius
4.
Possible side effects
5.
How to store Propofol Fresenius
6.
Contents of the pack and other information
1. WHAT PROPOFOL FRESENIUS IS AND WHAT IT IS USED FOR
Propofol Fresenius 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 % (10 MG/1 ML) FRESENIUS IS USED TO:

induce and maintain general anaesthesia in adults and children > 1
month.

sedate patients > 16 years of age receiving artificial respiration in
intensive care.

sedate adults and children > 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 FRESENIUS
_ _
DO NOT USE PROPOFOL FRESENIUS
-
if you are allergic to propofol or any of the other ingredients of
this medicine (listed in section 6).
-
if you are allergic to soya or peanut (see “Propofol Fresenius
contains soya-bean oil and sodium” at the
end of section 2).
-
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 Propofo

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2022
CRN00CK7Q
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or
infusion, vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml emulsion contains 10 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 mg propofol.
Excipients with known effect:
1 ml emulsion contains:
soya-bean oil, refined 100 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 % (10 mg/1 ml) Fresenius is a short-acting intravenous
general anaesthetic for
- induction and maintenance of general anaesthesia in adults and
children >1 month
- sedation for diagnostic and surgical procedures, alone or in
combination with local or regional anaesthesia in adults 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 Fresenius 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
Fresenius should not be administered by the same person
conducting the surgical or diagnostic procedure.
The dose of Propofol Fresenius emulsion should be individualised based
on the response of the patient and premedications
used.
Supplementary analgesic agents are generally required in addition to
Propofol Fresenius.
_ _
POSOLOGY
_ _
GENERAL ANAESTHESIA IN ADULTS
Induction of anaesthesia:
For induction of anaesthesia Propofol Fresenius sho