PROPOFOL LIPURO (propofol emulsion with medium and long chain triglycerides), anaesthetic

ANAESTHESIA - New indication
Opinions on drugs - Posted on Apr 22 2015

Reason for request

Extension of indication

No clinical benefit demonstrated for sedation during short diagnostic or surgical procedures in children

 

  • PROPOFOL LIPURO is a rapid-acting anaesthetic that now has Marketing Authorisation for sedation during diagnostic and therapeutic procedures, alone or in combination with local or regional anaesthesia in children. It should not be administered by the person performing the surgical or diagnostic procedure.

  • The dosage of 5 mg/mL is suitable for induction of sedation in children over 1 month of age. The dosage of 10 mg/mL is suitable for the sedation of children over 1 month of age and that of 20 mg/mL is suitable for children over 3 years of age.

  • No study has compared PROPOFOL LIPURO with HYPNOVEL, another anaesthetic with Marketing Authorisation in this indication in children.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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