Oseltamivir

Treatment of Influenza TAMIFLU (oseltamivir phosphate, capsules and powder for oral suspension) is indicated for:  The treatment of uncomplicated acute illness due to influenza infection in adults and adolescents (≥ 13 years) who have been symptomatic for no more than 2 days.

The treatment indication is based on two Phase III clinical studies of naturally occurring influenza in adults in which the predominant infection was influenza A (95%) and a limited number with influenza B (3%) and influenza of unknown type (2%), reflecting the distribution of these strains in the community.

The indication is also supported by influenza A and B challenge studies. No data are available to support the safety and efficacy of TAMIFLU in adult patients who commenced treatment after 40 hours of onset of symptoms.  The treatment of uncomplicated acute illness due to influenza in pediatric patients 1 year and older who have been symptomatic for no more than 2 days.

Treatment of influenza Oseltamivir is indicated in adults and children including full term neonates 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.

Prevention of influenza - Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. - The appropriate use of Oseltamivir for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.

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. 2). Oseltamivir is not a substitute for influenza vaccination.

The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. 1).

1 INDICATIONS AND USAGE Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.

1 ) Prophylaxis of influenza A and B in patients 1 year and older. 2 ) Limitations of Use : Not a substitute for annual influenza vaccination. 3 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.

3 ) Not recommended for patients with end-stage renal disease not undergoing dialysis. 1 Treatment of Influenza Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.

2 Prophylaxis of Influenza Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older. 3 Limitations of Use Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.

Treatment of influenza Ebilfumin is indicated in adults and children including full-term neonates 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.

Prevention of influenza 3 - Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. - The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.

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. 2). Ebilfumin is not a substitute for influenza vaccination.

The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. 1).