Diprivan 2% emulsion for infusion 50ml pre-filled syringes

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Propofol

Boleh didapati daripada:

Aspen Pharma Trading Ltd

Kod ATC:

N01AX10

INN (Nama Antarabangsa):

Propofol

Dos:

20mg/1ml

Borang farmaseutikal:

Emulsion for infusion

Laluan pentadbiran:

Intravenous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 15010100; GTIN: 5000455006393

Risalah maklumat

Page 1 of 5
For further copies of this leaflet, visit emc.medicines.org.uk or call
Aspen on +44 (0)1 748
828 391.
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPRIVAN 20 MG/ML (2%) EMULSION FOR INJECTION OR INFUSION
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 possible 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 3 years 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 pregnant (see the section called ‘Pregna

Ciri produk

OBJECT 1
DIPRIVAN 2% EMULSION FOR INJECTION
Summary of Product Characteristics Updated 07-Dec-2017 | Aspen
1. Name of the medicinal product
Diprivan 20 mg/ml (2%) emulsion for injection or infusion
2. Qualitative and quantitative composition
Propofol 20 mg/ml
Excipient(s) with known effect:
Soya-Bean Oil, Refined Ph Eur
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Emulsion for injection or infusion
White aqueous isotonic oil-in-water emulsion
4. Clinical particulars
4.1 Therapeutic indications
Diprivan 2% is a short-acting intravenous general anaesthetic for:
• Induction and maintenance of general anaesthesia in adults and
children >3 years.
• Sedation for diagnostic and surgical procedures, alone or in
combination with local or regional
anaesthesia in adults and children >3 years.
• Sedation of ventilated patients >16 years of age in the intensive
care unit.
4.2 Posology and method of administration
Posology
For specific guidance relating to the administration of Diprivan 2%
with a target controlled infusion (TCI)
device, which incorporates 'Diprifusor' TCI Software, see Section
4.2.5. Such use is restricted to
induction and maintenance of anaesthesia in adults. The 'Diprifusor'
TCI system is not recommended for
use in ICU sedation or in children.
4.2.1 INDUCTION OF GENERAL ANAESTHESIA
ADULTS
Diprivan 2% may be used to induce anaesthesia by infusion.
Administration of Diprivan 2% by bolus injection is not recommended.
Diprivan 2% may be used to induce anaesthesia by infusion but only in
those patients who will receive
Diprivan 2% for maintenance of anaesthesia.
In unpremedicated and premedicated patients, it is recommended that
Diprivan 2% should be titrated
(approximately 2 ml [40 mg] every 10 seconds in an average healthy
adult by infusion) against the
response of the patient until the clinical signs show the onset of
anaesthesia. Most adult patients aged less
than 55 years are likely to require 1.5–2.5 mg/kg of Diprivan 2%.
The total dose required can be reduced
by lower ra