NATCO PHARMA ASIA PTE. LTD.

<p><strong>3.1 Therapeutic indications</strong></p> <p><em>Treatment of influenza</em></p> <p>In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 4.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p> <p>Based on limited pharmacokinetic and safety data, oseltamivir phosphate capsules can be used in children 6 to 12 months of age for treatment during a pandemic influenza outbreak. The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.</p> <p><em>Prevention of influenza</em></p> <ul class="dash"> <li><p>Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.</p></li> <li><p>The appropriate use of oseltamivir phosphate capsules for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g., in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.</p></li> </ul> <p><u>Oseltamivir phosphate capsules are not a substitute for influenza vaccination.</u></p> <p>The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of antivirals for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses and the impact of the disease in different geographical areas and patient populations.</p>

<p><strong>1 INDICATIONS AND USAGE</strong></p> <p><strong>1.1 Chronic Lymphocytic Leukemia (CLL)</strong><br> Bendamustine hydrochloride for infusion is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.</p> <p><strong>1.2 Non-Hodgkin's Lymphoma (NHL)</strong><br> Bendamustine hydrochloride for infusion is indicated for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.</p>