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FUROSEMIDE-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
FUROSEMIDE-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
136 (255 working days)
Active ingredients
furosemide (frusemide)
Registration type
New generic medicine
Indication
Oedema
FUROSEMIDE-AFT (solution for injection ampoule) is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. It is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.
FUROSEMIDE-AFT injection is also indicated as adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset of diuresis is desired. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, FUROSEMIDE-AFT is indicated by the intravenous route. Parenteral use should be replaced with oral furosemide (frusemide) as soon as practical.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine