NOVEM HEALTHCARE PTE LTD

<p><strong>THERAPEUTIC INDICATIONS</strong><br> <u>Hypertension</u><br> Treatment of essential hypertension.</p> <p><u>Chronic heart failure (CHF)</u><br> Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients &gt; 70 years.</p>

<p><strong>INDICATIONS</strong></p> <p>Dalisoon is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.</p>

**4.1. Therapeutic Indications** Sertraline is indicated for the treatment of symptoms of depression, including depression accompanied by symptoms of anxiety, in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes. Sertraline is also indicated for the treatment of obsessive compulsive disorder (OCD). Following initial response, sertraline has been associated with sustained efficacy, safety and tolerability in up to 2 years of treatment of OCD. Sertraline is indicated for the treatment of panic disorder, with or without agoraphobia. Sertraline is indicated for the treatment of post-traumatic stress disorder (PTSD). Sertraline is indicated for the treatment of social phobia (social anxiety disorder). Sertraline is indicated for the treatment of pre-menstrual dysphoric disorder (PMDD). Sertraline is not indicated for use in children and adolescents under 18 years of age (see section **4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

<p><strong>1 INDICATIONS AND USAGE</strong></p> <p><strong>1.1 Intensive Care Unit Sedation</strong></p> <p>Dexmedetomidine HCl is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine HCl should be administered by continuous infusion not to exceed 24 hours.</p> <p>Dexmedetomidine HCl has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine HCl prior to extubation.</p> <p><strong>1.2 Procedural Sedation</strong></p> <p>Dexmedetomidine HCl is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.</p>

**4.1 Therapeutic Indications** Ketorolac Injection is indicated for the short-term management of moderate to severe acute post-operative pain that requires analgesia at the opioid level. Treatment should only be initiated in hospitals. The maximum duration of treatment is 5 days.

<p><strong>1 INDICATIONS AND USAGE</strong></p> <p>HEPURI is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.</p> <p>The following points should be considered when initiating therapy with HEPURI:</p> <ul class ="nobull"> <li>&rarr; This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-na&iuml;ve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease [see <em>Clinical Studies (12)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li> <li>&rarr; Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease [see <em>Adverse Reactions (5)</em> and <em>Clinical Studies (12.1)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li> <li>&rarr; Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see <em>Warnings and Precautions (4.2)</em> and <em>Clinical Studies (12.1)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li> </ul>