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Tamiflu (oseltamivir phosphate) - Jan 4, 2007

Audience: Pediatric and primary care healthcare professionals and patients

Indication: Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days.
[Posted 01/04/2007] Roche notified healthcare professionals of a correction to a Dear Healthcare professional letter issued on November 13, 2006. The original letter referenced changes to the PRECAUTIONS Section of prescribing information for Tamiflu about post marketing reports of self-injury and delirium with the use of Tamiflu in patients with influenza. The prescribing information that accompanied the letter contained an incorrect dosing chart for the Standard Dosage of Tamiflu Oral Suspension for prophylaxis of influenza in pediatric patients. The chart incorrectly specified twice daily instead of once daily dosing under "Recommended Dose" for 10 days. Healthcare professionals should discard the incorrect version of the package insert included in the November 13, 2006 mailing and refer to the new dosing chart included in the December 26, 2006 letter.

[December 26, 2006 - Letter - Roche]