PROPOFOL 10 Micromol Emulsion for Inj/Inf

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

PROPOFOL

Fáanlegur frá:

Hospira Enterprises B.V.

INN (Alþjóðlegt nafn):

PROPOFOL

Skammtar:

10 Micromol

Lyfjaform:

Emulsion for Inj/Inf

Gerð lyfseðils:

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

Leyfisstaða:

Withdrawn

Leyfisdagur:

2013-07-31

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER 

PROPOFOL 10 MG/ML, EMULSION FOR INJECTION OR INFUSION 

Propofol 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor. 
- 
This medicine has been prescribed for you. Do not pass it on to
others. It may harm 
them, even if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this 
leaflet, please tell your doctor. 

IN THIS LEAFLET:  
1. 
What Propofol 10 mg/ml is and what it is used for 
2. 
Before you use Propofol 10 mg/ml 
3. 
How to use Propofol 10 mg/ml 
4. 
Possible side effects 
5 
How to store Propofol 10 mg/ml 
6. Further 
information 

1. 
WHAT IS PROPOFOL 10 MG/ML AND WHAT IT IS USED FOR 

MEDICINAL PRODUCT GROUP 
Propofol 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 too sedate you (so that you are
sleepy but not completely 
asleep).  

WHAT IS PROPOFOL USED FOR? 
•  TO induce and maintain general anaesthesia in adults and
children more than 1 month  
•  To sedate patients more than 16 years of age receiving
artificial respiration in 
intensive care  
•  To sedate adults and children more than 1 month during
diagnostic and surgical 
procedures, alone or in combination with local or regional
anaesthesia  

2. 
BEFORE YOU USE PROPOFOL 10 MG/ML 

DO NOT USE PROPOFOL 10 MG/ML: 
− 
in patients of 16 years of age or younger for sedation in intensive
care 
− 
if you are allergic (hypersensitive) to the Propofol active substance
or to any of the 
excipients  
−    if you are allergic to peanut or soya. Propofol 10 mg/ml
contains Soya oil. 

TAKE SPECIAL CARE WITH PROPOFOL 1

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol 10mg/ml emulsion for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Emulsion for injection or infusion contains 10 mg Propofol.
Excipient: 1 ml Emulsion for injection or infusion contains 100 mg Soya-bean oil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection or infusion.
White to slight off-white emulsion for injection or infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propofol 10 mg/ml is a short acting intravenous general anaesthetic for:
• Induction and maintenance of general anaesthesia in adults and children more than 1 month.
• Sedation of ventilated patients more than 16 years of age in the intensive care unit.
• Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in
adults and children more than 1 month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Supplemental analgesic agents are normally needed during Propofol administration. In addition, please refer to Section
4.4 Special Warnings and Special Precautions for Use, for additional usage information.
_General Anaesthesia in Adults_
Induction: Propofol 10 mg/ml may be used for induction of anaesthesia as slow bolus injection or infusion.
Propofol should be titrated to clinical response, where the patient shows sign of anaesthesia (usually about 20-40 mg
every 10 seconds). Most adults under 55 years of age will need 1.5 to 2.5 mg/kg.
Elderly patients usually need lower doses. Patients in ASA class 3 and 4, especially those with impaired cardiac
function, the dosage requirements will be less and the total dose may be reduced to a minimum of 1 mg of propofol/kg
body. The total dose could be reduced