Zanamivir

Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when: • The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or • Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.

Dectova should be used in accordance with official guidance.

Treatment of influenza Relenza is indicated for treatment of both influenza A and B in adults and children (≥ 5 years) who present with symptoms typical of influenza when influenza is circulating in the community. 1 for children aged 5-11 years).

g. in case of a mismatch between circulating and vaccine strains and a pandemic situation). Relenza is not a substitute for influenza vaccination. The appropriate use of Relenza for prevention of influenza should be determined on a case-by-case basis depending on the circumstances and the population requiring protection.

The use of antivirals for the treatment and prevention of influenza should take into consideration official recommendations, the variability of epidemiology, and the impact of the disease in different geographical areas and patient populations.

28 Page 3 of 33 RELENZA zanamivir dry powder for inhalation for use with the DISKHALER Inhalation Device PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Oral inhalation Dry powder 5 mg/blister lactose For a complete listing see Dosage Forms, Composition and Packaging section.

INDICATIONS AND CLINICAL USE Treatment of Influenza RELENZA (zanamivir dry powder for inhalation) is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older, who have been symptomatic for no more than 2 days.

No data are available to support zanamivir safety and efficacy in patients who receive treatment after 48 hours of symptoms. This indication is based on placebo controlled studies conducted in North America, the Southern Hemisphere, and Europe during their respective influenza seasons.