PROPOFOL 10 Mg/Ml Emulsion for Inj/Inf

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PROPOFOL

Disponível em:

UAB Norameda

Código ATC:

N01AX10

DCI (Denominação Comum Internacional):

PROPOFOL

Dosagem:

10 Mg/Ml

Forma farmacêutica:

Emulsion for Inj/Inf

Tipo de prescrição:

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

Área terapêutica:

Other general anesthetics

Status de autorização:

Authorised

Data de autorização:

2011-08-19

Folheto informativo - Bula

1/10 
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.  
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor
or pharmacist.  
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist.  

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

1. WHAT PROPOFOL  IS  AND WHAT IT IS  USED FOR  Propofol  belongs to  a  group of medicines  called 
general anaesthetics. General anaesthetics are used to cause unconsciousness (deep sleep) while 
surgical operations or other procedures are being carried
out. They can also be used to sedate you 
(make you sleepy without sending you to sleep).  

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

2. BEFORE YOU ARE GIVEN PROPOFOL 
DO  NOT  USE  PROPOFOL:  -  in  patients  allergic  (hypersensitive)  to  propofol,  or  any  of  the  other 
ingredients of this medicinal product 
- in patients allergic (hypersensitive) to soya or peanut 
- in patients of 16 years of age or younger for sedation in
intensive care 

TAKE SPECIAL CARE WITH PROPOFOL 

You should not receive Propofol, or only under ext

Características técnicas

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:
Each ml of emulsion for injection/infusion contains: Soya bean oil
refined 50 mg
Sodium 0.035 mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for injection/infusion.
White 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 is a short-acting intravenous general anaesthetic agent 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
Propofol must only be given in hospitals or adequately equipped day
therapy units by physicians trained in anaesthesia
or in the care of patients in intensive care.
Circulatory and respiratory functions should be constantly monitored
(e.g.
ECG,
pulse oxymetry) and facilities for
maintenance of patient airways, artificial ventilation, and other
resuscitation facilities should be immediately available
at all times.
For
sedation during surgical
and diagnostic procedures Propofol
should not
be administered by the same person
conducting the surgical or diagnostic procedure.
The dose of Propofol should be individualised based on the response of
the patient and premedications used.
Supplementary analgesic agents are generally required in addition to
Propofol.
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