Diprivan 1% emulsion for infusion 50ml pre-filled syringes

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Propofol

Disponibil de la:

Aspen Pharma Trading Ltd

Codul ATC:

N01AX10

INN (nume internaţional):

Propofol

Dozare:

10mg/1ml

Forma farmaceutică:

Emulsion for infusion

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 15010100; GTIN: 5000455006379

Prospect

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 10 MG/ML (1%) 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 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 pregnant (see the section called ‘Pregnan

Caracteristicilor produsului

OBJECT 1
DIPRIVAN 1%
Summary of Product Characteristics Updated 07-Dec-2017 | Aspen
1. Name of the medicinal product
Diprivan 10 mg/ml (1%) emulsion for injection or infusion
2. Qualitative and quantitative composition
Propofol 10 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 1% 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
POSOLOGY
For specific guidance relating to the administration of Diprivan 1%
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 sedation for surgical and diagnostic
procedures, or in children.
4.2.1 INDUCTION OF GENERAL ANAESTHESIA
ADULTS
In unpremedicated and premedicated patients, it is recommended that
Diprivan 1% should be titrated
(approximately 4 ml [40 mg] every 10 seconds in an average healthy
adult by bolus injection or 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 1%. The total dose
required can be reduced by lower rates of administration (2–5 ml/min
[20–50 mg/min]). Over this age, the
requirement will generally be less. In patients of ASA Grades 3 and 4,
lower rates of administration
should be used (approximately 2 ml [20 mg] every