Propofol

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

PROPOFOL

Доступна з:

Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

Код атс:

N01AX10

ІПН (Міжнародна Ім'я):

PROPOFOL 500 mg

Фармацевтична форма:

EMULSION FOR INFUSION OR INJECTION

Склад:

PROPOFOL 500 mg

Тип рецепту:

POM

Терапевтична области:

ANESTHETICS

Статус Авторизація:

Withdrawn

Дата Авторизація:

2014-09-22

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL 10 MG/ML (1%) 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 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 Propofol 10 mg/ml (1%) is and what it is used for
2.
What you need to know before you are given Propofol 10 mg/ml (1%)
3.
How you will be given Propofol 10 mg/ml (1%)
4.
Possible side effects
5.
How to store Propofol 10 mg/ml (1%)
6.
Contents of the pack and other information
1.
WHAT PROPOFOL 10 MG/ML (1%) IS AND WHAT IT IS USED FOR
Propofol 10 mg/ml (1%) contains the active substance propofol. It
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 10 mg/ml (1%) 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 ARE GIVEN PROPOFOL 10 MG/ML (1%)
YOU WILL NOT BE GIVEN PROPOFOL 10 MG/ML (1%) IF:
-
you are allergic to propofol or any of the other ingredients of this
medicine (listed in section 6).
-
you are allergic to peanut or soya. This is because Propofol 10 mg/ml
(1%) contains soya oil.
-
you are 16 years of

Характеристики продукта

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propofol 10 mg/ml (1%) Emulsion for Injection /Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of emulsion for injection/infusion contains 10 mg of propofol.
Each 20 ml vial contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.
Excipient with known effect
Each ml of emulsion for injection/infusion contains 100 mg of
soya-bean oil and approximately
0.016 mmol (0.4 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for Injection /Infusion.
White or slightly off- white emulsion, having a milk-like appearance
with no evidence of oiling-out
of the emulsion and free from visible particulate.
pH: 6.0 - 8.5
Osmolality: 300-330 mOsm/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propofol 10mg/ml (1%) is a short-acting intravenous general
anaesthetic for:

Induction and maintenance of general anaesthesia in adults and
children over 1 month.

Sedation for diagnostic and surgical procedures, alone or in
combination with local or regional
anaesthesia in adults and children over 1 month.

Sedation of ventilated patients over 16 years of age in the intensive
care unit.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lower doses of propofol may be necessary when general anaesthesia is
used in addition to regional
anaesthesia.
Posology
ADULTS
Page 2 of 14
_Induction of General Anaesthesia _
In un-premedicated and premedicated patients, it is recommended that
propofol 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 propofol. 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 gener