WELLESTA HEALTHCARE (SINGAPORE) PTE. LTD.

<p><strong>1 INDICATIONS AND USAGE</strong></p> <p><strong>1.1 Complicated Skin and Skin Structure Infections (cSSSI)</strong><br> Adult (&ge;18 years of age) and pediatric (1 to 17 years of age) patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: <em>Staphylococcus aureus</em> (including methicillin-resistant isolates), <em>Streptococcus pyogenes</em>, <em>Streptococcus agalactiae</em>, <em>Streptococcus dysgalactiae</em> subsp. <em>equisimilis</em>, and <em>Enterococcus faecalis</em> (vancomycin-susceptible isolates only).</p> <p><strong>1.2 <em>Staphylococcus aureus</em> Bloodstream Infections (Bacteremia)</strong><br> Adult patients (&ge;18 years of age) with <em>Staphylococcus aureus</em> bloodstream infections (bacteremia), including those with right-sided infective endocarditis (SAB/RIE), caused by methicillin-susceptible and methicillin-resistant isolates.</p> <p>Pediatric patients (1 to 17 years of age) with <em>S. aureus</em> bloodstream infections (bacteremia) caused by methicillin-susceptible and methicillin-resistant isolates.</p> <p>Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis due to <em>S. aureus</em>. The efficacy of daptomycin for injection in patients with left-sided infective endocarditis due to <em>S. aureus</em> has not been demonstrated. The clinical trial of Daptomycin for injection in patients with <em>S.aureus</em> bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor. Daptomycin for injection has not been studied in patients with prosthetic valve endocarditis.</p> <p>Daptomycin for injection is not indicated for the treatment of pneumonia <em>[See 5 WARNINGS AND PRECAUTIONS, 5.2 Pneumonia</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>