CURAM (Sandoz Pty Ltd)
Product name
CURAM
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
159 working days (255)
Active ingredients
amoxicillin sodium; potassium clavulanate
Registration type
New generic medicine
Indication
CURAM (powder for injection) is indicated for the short term treatment of serious bacterial infections such as:
- Upper Respiratory Tract Infections (including ENT): e.g. mastoiditis, tonsillitis, otitis media, epiglottitis and sinusitis when accompanied by severe signs and symptoms
- Lower Respiratory Tract Infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia
- Genito-urinary Tract Infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections
- Gastrointestinal infections: e.g. intra-abdominal sepsis, peritonitis
- Skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess
- Other Infections e.g. septic abortion, puerperal sepsis, post-surgical infections
- Curam is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications e.g. gastrointestinal surgery.