BUPIVACAINE (Phebra Pty Ltd)
Product name
BUPIVACAINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
adrenaline (epinephrine) acid tartrate, bupivacaine hydrochloride monohydrate
Registration type
New generic medicine
Indication
Bupivacaine 0.25% with Adrenaline 1:400,000 Phebra solution is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows:
Surgical anaesthesia
- Epidural block for surgery.
- Field block (minor and major nerve blocks and infiltration).
Analgesia
- Intermittent bolus epidural administration for analgesia in postoperative pain or labour pain.
- Field block (minor nerve block and infiltration).