REMIFENTANIL DEMOGEN (Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals)
Product name
REMIFENTANIL DEMOGEN
Date registered
Evaluation commenced
Decision date
Approval time
148 (255 working days)
Active ingredients
remifentanil hydrochloride
Registration type
New generic medicine
Indication
REMIFENTANIL DEMOGEN is indicated
- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.
- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.
- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.
- for provision of analgesia and sedation in mechanically ventilated intensive care patients.