Propofol 20 mg/ml Emulsion for injection/infusion

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Propofol

Доступна с:

Baxter Holding B.V.

код АТС:

N01AX; N01AX10

ИНН (Международная Имя):

Propofol

дозировка:

20 milligram(s)/millilitre

Фармацевтическая форма:

Emulsion for injection/infusion

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Other general anesthetics; propofol

Статус Авторизация:

Marketed

Дата Авторизация:

2011-08-19

тонкая брошюра

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL 20 MG/ML 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 pharmacist or
nurse.
•
If
you get any side effects, talk to your doctor or 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 20 mg/ml is and what it is used for
2. What you need to know
before you are given Propofol 20 mg/ml
3. How you are given Propofol 20 mg/ml
4. Possible side effects
5. How to store Propofol 20 mg/ml
6. Contents of the pack and other information.
1. WHAT PROPOFOL 20 MG/ML IS AND WHAT IT IS USED FOR
Propofol 20 mg/ml contains an active substance called propofol.
Propofol 20 mg/ml belongs to a group
of medications that are called general anaesthetics. General
anaesthetics are used trigger unconsciousness
(a type of sleep), so that surgeries and other treatments can be
performed. They can also be used for
sedation (so that you are sleepy but are not really sleeping).
PROPOFOL 20 MG/ML IS USED FOR
•
To put patients to sleep (called induction of anaesthesia) and to keep
patients asleep (called
maintenance of anaesthesia) in adults and children over 3 years of
age,
•
Sedation (calming) of ventilated patients over 16 years of age during
intensive care,
•
• Sedation of adults and children over 3 years of age for surgical
and diagnostic procedures,
alone or in combination with local or regional anaesthesia (local
anaesthetic).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PROPOFOL 20 MG/ML
DO NOT USE PROPOFOL 20 MG/ML
:
•
if you are allergic to propofol, soybeans, peanuts or any of the other
ingredients of this medicine
(listed in section 6),
•
for the sedation of patients aged 16 years or younger as part of
intensive care.
•
a
s anaesthesia in children under

Характеристики продукта

Health Products Regulatory Authority
18 July 2023
CRN00DG79
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol 20 mg/ml Emulsion for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of emulsion for injection/infusion contains 20 mg of propofol.
Each 50 ml vial contains 1000 mg of propofol
Excipient with known effect:
Each ml of emulsion for injection/infusion contains: Soya bean oil
refined 50 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for injection/infusion.
White milky oil-in-water emulsion.
Osmolality: 250 to 390 mOsm/Kg.
pH between 6.00 and 8.50
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propofol 20 mg/ml is a short-acting intravenous anaesthetic for the
- induction and maintenance of anaesthesia in adults and children over
3 years of age,
-sedation of ventilated patients over 16 years of age during intensive
care,
- sedation of adults and children over 3 years of age for surgical and
diagnostic procedures, alone or in combination with local
or regional anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Propofol 20 mg/ml may only be administered by doctors that have been
trained in anaesthesiology or intensive care. Sedation
or anaesthesia with Propofol 20 mg/ml and the surgical or diagnostic
procedure may not be performed by the same person.
The cardiac, circulatory and respiratory functions should be
continuously monitored (e.g. ECG, pulse oxymetry). The customary
equipment for possible accidents during anaesthesia or sedation must
be ready for use at all times.
The dosage should be adjusted individually while taking the
premedication and the patient's reaction into consideration.
Normally, the additional administration of analgesics is necessary.
Administration of boluses with Propofol 20 mg/ml is not recommended.
_ _
_ANAESTHESIA FOR ADULTS:_
Induction of anaesthesia:
For induction of anaesthesia, Propofol 20 mg/ml is administered,
titrated at a speed of 20 - 40 mg Propofol every 10 seconds,
by m