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MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white…
Therapeutic Indications: Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with (cisplatin or carboplatin)In…
This DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected version 2.1, July 2017 supersedes version 2.1 of the table dated March 2017. Changes to note in this corrected version 2.1 of the Severity Grading Table are parameter specific and are highlighted below in…
The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 contains a number of parameter level (i.e., adverse event) severity grading criteria changes detailed below when compared with the Division of AIDS Table for Grading the S everity of Adult…
The Division of AIDS Table for grading the severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) is a collection of commonly encountered adverse events and their descriptive terminology utilized for severity grading. As part of its standard review processes, DAIDS reassessed the “…
PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more anti-tuberculosis (anti-TB) drugs to which the isolate is susceptible. (1.1) *…
Use this to make sure you don't miss any required pieces of information when recording and reporting an adverse event.
One-sheet references for writing a narrative case summary of an adverse event and for evaluation and follow-up.
The following side effects have been associated with the use of raltegravir:
Ribasphere is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…
Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…
Rifampin is indicated in the treatment of all forms of tuberculosis.
The following side effects have been associated with the use of rifapentine:
NORVIR is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
.zip file contains: Case review on adverse events Safety training presentations on adverse events, expedited reporting and assessment, Expedited reporting via DAERS a safety training case study handout Training given in the Republic of South Africa in October 2016.
This form is to document that the signator of this document is authorized to use the DAIDS-ES system, and understands that their electronic signature (eSignature) is used to electronically sign database records.
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) VIREAD is indicated…
The following side effects have been associated with the use of tenofovir: