SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS (Micro Labs Pty Ltd)
Product name
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
149 working days (255)
Active ingredients
sodium nitroprusside
Registration type
New generic medicine
Indication
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS (concentrated solution for injection) are indicated for:
- Immediate reduction of blood pressure in patients with hypertensive crises. Concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.
- Producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.
- Short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine