MEDICELL PHARMACEUTICAL (S) PTE. LTD.

<p><strong>4.1 Therapeutic indications</strong></p> <p>Esomeprazole tablets are indicated for:</p> <p><strong>Gastroesophageal Reflux Disease (GERD)</strong></p> <ul> <li>Treatment of erosive reflux esophagitis.</li> <li>Long-term management of patients with healed esophagitis to prevent relapse.</li> <li>Symptomatic treatment of gastroesophageal reflux disease (GERD).</li> </ul> <p><strong>In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and</strong></p> <ul> <li>Healing of <em>Helicobacter pylori</em> associated duodenal ulcer and</li> <li>Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.</li> </ul> <p><strong>Patients requiring continued NSAID therapy</strong></p> <ul> <li>Healing of gastric ulcers associated with NSAID therapy.</li> <li>Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Patients are considered to be at risk due to their age (&ge; 60) and/or documented history of gastric and/or duodenal ulcers. Controlled studies do not extend beyond 6 months.</li> </ul> <p><strong>Patients requiring continued low dose aspirin (75&ndash;325 mg) therapy</strong></p> <ul> <li>Prevention of gastric and/or duodenal ulcers associated with low dose aspirin therapy, in patients at risk.</li> </ul> <p><strong>Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole IV solution by intravenous infusion.</strong></p> <p><strong>Treatment of Zollinger Ellison Syndrome</strong></p>

**1 INDICATIONS AND USAGE** pms-ENTECAVIR (entecavir) 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. The following points should be considered when initiating therapy with pms-ENTECAVIR: - This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease \[see _Clinical Studies (12)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. - Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease \[see _Adverse Reactions (5)_ and _Clinical Studies (12.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. - 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 \[see _Warnings and Precautions (4.2)_ and _Clinical Studies (12.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].

<p><strong>4.1 Therapeutic indications</strong><br> Oramorph is indicated for the symptomatic relief of severe chronic pain.</p>

**THERAPEUTIC INDICATIONS** Donepezil Hydrochloride tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia.