Ciprofloxacin Anthrax post-exposure prophylaxis

7/27/00


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Table of Contents

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Ciprofloxacin Anthrax post-exposure prophylaxis

Agenda

Introduction

Proposed Labeling

Approved CIPROŽ Formulations

Approved CIPROŽ Oral and I.V. Indications

Events Leading to Anthrax Submission

Events Leading to Anthrax Submission

Events Leading to Anthrax Submission

Events Leading to Anthrax Submission

Events Leading to Anthrax Submission

Concurrent Events

Final Events Leading to Anthrax Submission

Rationale for the Use of Ciprofloxacin

Pharmacokinetics/Pharmacodynamics

Pharmacokinetics/Pharmacodynamics

Pharmacokinetics/Pharmacodynamics

Tissue Penetration

CIPROŽ Clinical Database

Review of US Lower Respiratory Tract Infection Clinical Database

Clinical Success Rates in the LRTI Pooled Studies

Review of Overall Clinical Trials Safety Database

Review of Global Clinical Trials Safety Database

CIPROŽ Pediatric Experience

Review of Controlled Pediatric Clinical Trial Safety Database

Ciprofloxacin Global Clinical Trials Pediatric Safety Database

CIPROŽ Pediatric Experience

CIPROŽ Pediatric Experience

CIPROŽ - Review of Global Post-Marketing Safety Database

Ciprofloxacin Spontaneous ADE Reports1 Ten Most Frequently Reported Events (All Formulations)

Most Frequently Reported Ciprofloxacin Spontaneous ADE Reports1 By Age (When Known) (All Formulations)

Ciprofloxacin Spontaneous ADE Reports1 Ten Most Frequently Reported Serious Events (All Formulations)

Summary

Conclusions

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Author: Steve Turner