MSD PHARMA (SINGAPORE) PTE. LTD.

**V. INDICATIONS** **Adults** ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response (see VIId. Clinical Studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatrics** ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older. This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age (see VIId. Clinical Studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of ISENTRESS 400 mg tablets have not been established in children less than 6 years of age. The safety and efficacy of ISENTRESS chewable tablets have not been established in children less than 2 years of age.

<p><strong>1. INDICATIONS AND USAGE</strong></p> <p>PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).</p> <p>PREVYMIS is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].</p>

<p><strong>1. INDICATIONS AND USAGE</strong></p> <p>PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).</p> <p>PREVYMIS is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].</p>

<p><strong>1. INDICATIONS AND USAGE</strong></p> <p>PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).</p> <p>PREVYMIS is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].</p>

<p><strong>1 INDICATIONS AND USAGE</strong></p> <p><strong>1.1 Acute Bacterial Skin and Skin Structure Infections</strong><br> SIVEXTRO is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: <em>Staphylococcus aureus</em> (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), <em>Streptococcus pyogenes</em>, <em>Streptococcus agalactiae</em>, <em>Streptococcus anginosus</em> Group (including <em>Streptococcus anginosus</em>, <em>Streptococcus intermedius</em>, and <em>Streptococcus constellatus</em>), and <em>Enterococcus faecalis</em>.</p> <p><strong>1.2 Usage</strong><br> To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</p>