ORIENT EUROPHARMA PTE LTD

<p><strong>4. INDICATION AND USAGE</strong></p> <p>ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease.</p>

<p><strong>1 INDICATIONS AND USAGE</strong></p> <p><strong>1.1 Monotherapy Epilepsy</strong><br> TROKENDI XR&reg; is indicated in patients 6 years of age and older as initial monotherapy for partial onset or primary generalized tonic-clonic seizures [<em>see Clinical Studies (14.2)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p> <p><strong>1.2 Adjunctive Therapy Epilepsy</strong><br> TROKENDI XR&reg; is indicated as adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome [<em>see Clinical Studies (14.3)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p> <p><strong>1.3 Migraine</strong><br> TROKENDI XR&reg; is indicated for the prophylaxis of migraine headache in adult patients [<em>see Clinical Studies (14.4)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>

**1\. INDICATIONS AND USAGE** Vancomycin Hydrochloride Capsule is indicated for the treatment of _C. difficile_-associated diarrhea. Vancomycin Hydrochloride Capsule is also used for the treatment of enterocolitis caused by _Staphylococcus aureus_ (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use - Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsule must be given orally for these infections. - **Orally administered Vancomycin Hydrochloride Capsule is not effective for other types of infections.** To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsule and other antibacterial drugs, Vancomycin Hydrochloride Capsule should be used only to treat or to prevent infections 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><strong>1. INDICATIONS AND USAGE</strong><br> Vancomycin Hydrochloride Capsule is indicated for the treatment of <em>C. difficile</em>-associated diarrhea. Vancomycin Hydrochloride Capsule is also used for the treatment of enterocolitis caused by <em>Staphylococcus aureus</em> (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.<br> <u>Limitations of Use</u></p> <ul> <li>Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsule must be given orally for these infections.</li> <li><strong>Orally administered Vancomycin Hydrochloride Capsule is not effective for other types of infections.</strong></li> </ul> <p>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsule and other antibacterial drugs, Vancomycin Hydrochloride Capsule should be used only to treat or to prevent infections 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>

<p><strong>4.1 Therapeutic indications</strong></p> <p><u>Chronic obstructive pulmonary disease (COPD)</u></p> <p>Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p> <p><u>Asthma</u></p> <p>Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.</p>

**Therapeutic indications** **Asthma** Foster is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. **COPD** Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.