Diprivan 1% w/v Emulsion for Injection or Infusion, Pre filled Syringe

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

PROPOFOL

Dostupné s:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

ATC kód:

N01AX10

INN (Mezinárodní Name):

PROPOFOL 10 mg/ml

Léková forma:

EMULSION FOR INFUSION OR INJECTION

Složení:

PROPOFOL 10 mg/ml

Druh předpisu:

POM

Terapeutické oblasti:

ANESTHETICS

Stav Autorizace:

Withdrawn

Datum autorizace:

2005-10-31

Informace pro uživatele

Page 1 of 20
F
or further copies of this leaflet, visit www.medicines.ie or call
Aspen on [phone]/ + 356
21497982
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPRIVAN 1% W/V EMULSION FOR INJECTION OR INFUSION, PRE-FILLED SYRINGE
propofol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING 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 nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Diprivan is and what it is used for
2.
What you need to know before you use Diprivan
3.
How to use Diprivan
4.
Possible side effects
5.
How to store Diprivan
6.
Contents of the pack and other information
1. WHAT DIPRIVAN IS AND WHAT IT IS USED FOR
Diprivan contains a medicine called propofol. This 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).
Diprivan will be given to you as an injection by a doctor.
In adults and children over 1 month of age it is used to:
•
Help put you to sleep
BEFORE
an operation or other procedure.
•
Keep you asleep
DURING
an operation or other procedure.
•
Sedate you during diagnostic and surgical procedures, alone or in
combination with local or
regional anaesthesia.
In people over 16 years of age it is also used to:
•
Sedate you when receiving artificial respiration in an Intensive Care
Unit (ICU).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIPRIVAN
DO NOT USE DIPRIVAN:
•
If you are allergic to propofol or any of the other ingredients of
this medicine (listed in section 6).
•
If you are allergic to peanut or soya. This is because Diprivan
contains soya oil.
•
If you are 16 years of age or younger fo

Charakteristika produktu

Summary of Product Characteristics
Page 1 of 16
1.
NAME OF THE MEDICINAL PRODUCT
Diprivan 1% w/v Emulsion for Injection or Infusion, Pre-filled
Syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propofol 10mg/ml
Each 50ml pre-filled syringe contains 500 mg propofol
Excipient(s) with known effect:
Contains sodium 0.0018 mmol/ml.
Contains refined soya-bean oil 100 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection or infusion.
White or almost white emulsion for injection or infusion, supplied in
pre-filled syringes.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diprivan is a short-acting intravenous general anaesthetic for:
•
Induction and maintenance of general anaesthesia in adults and
children over one month of age.
•
Sedation for diagnostic and surgical procedures, alone or in
combination with local or regional
anaesthesia in adults and children over one month of age.
•
Sedation of ventilated patients over 16 years of age in the intensive
care unit.
Diprivan may be administered by a 'Diprifusor' TCI system for
induction and maintenance of general
anaesthesia and conscious sedation for surgical and diagnostic
procedures in adults only.
Administration of Diprivan by a 'Diprifusor' TCI system is not
recommended for any indication in
children or adolescents under 16 years old. Administration of Diprivan
by a 'Diprifusor' TCI system is
not recommended for intensive care sedation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Supplementary analgesic agents are generally required in addition to
Diprivan.
Summary of Product Characteristics
Page 2 of 16
For specific guidelines relating to the administration of Diprivan
using the 'Diprifusor' target controlled
infusion (TCI) system, which incorporates 'Diprifusor' TCI software,
see section E. Such use is
restricted to induction and maintenance of anaesthesia and conscious
sedation for surgical and
diagnostic procedures in adults. The 'Diprifusor' TCI system is not
recommended for use in ICU
sedation,