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The following side effects have been associated with the use of abacavir:

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Tutorial guide, with screenshots, for the DAIDS-ES system.

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Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.

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Guidance table for grading the severity of adult and pediatric adverse events with female genital involvement during microbicide studies.

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Guidance table for grading the severity of adult and pediatric adverse events with male genital involvement during microbicide studies.

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Guidance table for grading the severity of adult and pediatric adverse events with rectal involvement during microbicide studies.

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SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by…

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Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.


Temporary importation of Bleomycin Sulfate Powder for Injection, 15,000 International Units (IU) to address drug shortage issue


COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 

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Line by line instructions for how to complete the Expedited Adverse Events reporting form.

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COZAAR is an angiotensin II receptor blocker (ARB) indicated for:

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Term definitions and access rights for Reporters and Submitters using DAERS.

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Technical guide to the DAERS system for Site Enrollment users.

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Detailed manual on the DAERS system for Site Reporters and Study Physicians.

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Formatted specifically for printing. applicable, to special instructions to keep in mind while entering values.

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Definitions of the types of safety information distributed by DAIDS and methods of distribution.

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Training workshop in Durban, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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Training workshop in Johannesburg, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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