Propofol 10 mg/ml Emulsion for injection/infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Propofol

Commercializzato da:

Baxter Holding B.V.

Codice ATC:

N01AX; N01AX10

INN (Nome Internazionale):

Propofol

Dosaggio:

10 milligram(s)/millilitre

Forma farmaceutica:

Emulsion for injection/infusion

Tipo di ricetta:

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

Area terapeutica:

Other general anesthetics; propofol

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2011-08-19

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL 10 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 10 mg/ml is and what it is used for
2. What you need to know before you are given Propofol 10 mg/ml
3. How you are given Propofol 10 mg/ml
4. Possible side effects
5. How to store Propofol 10 mg/ml
6. Contents of the pack and other information.
1. WHAT PROPOFOL 10 MG/ML
IS AND WHAT IT IS USED FOR
Propofol 10 mg/ml contains an active substance called propofol.
Propofol 10 mg/ml belongs to a group of
medications that are called general anaesthetics. General anaesthetics
are used to 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 10 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 from 1 month of
age,
•
Sedation (calming) of ventilated patients over 16 years of age during
intensive care,
•
Sedation of adults and children from 1 month 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 10 MG/ML
DO NOT USE PROPOFOL 10 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.
WARNINGS AND PRECAUTIONS
Talk to your doct

Scheda tecnica

Health Products Regulatory Authority
18 July 2023
CRN00DG79
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol 10 mg/ml 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: 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 10 mg/ml is a short-acting intravenous anaesthetic for the
- Induction and maintenance of anaesthesia in adults and children from
1 month of age,
- sedation of ventilated patients over 16 years of age during
intensive care,
- Sedation of adults or children from 1 month of age for surgical and
diagnostic procedures, alone or in combination with local
or regional anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Propofol 10 mg/ml may only be administered by doctors that have been
trained in anaesthesiology intensive care. Sedation or
anaesthesia with Propofol 10 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.
_ _
_ _
_ANAESTHESIA FOR ADULTS:_
Induction of anaesthesia:
For the induction of anaesthesia, Propofol 10 mg/ml is administered,
titrated at a speed of 20 - 40 mg propo