The purpose of this site is to make the package inserts for South African medicines available to the public in electronic format. One tool used by the courts as evidence of standard of care has been the PI. Similarly, the product catalog available on the websites of generic manufacturers will also typically link the user to the PI for that particular drug product. 0000003282 00000 n
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As of April 2015, DailyMed contained the most up-to-date PIs for over 73,000 products. 0000443720 00000 n
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All rights reserved. 0000428099 00000 n
Fleeger CA, editor. 0000437776 00000 n
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USP dictionary of USAN and international drug names 1996. 0000005471 00000 n
Sulfamethoxazole and trimethoprim package insert (Septra, Septra DS; Glaxo Wellcome—US). 0000004678 00000 n
Therefore, pharmacists are discouraged from taking this approach when searching for the PI. Pharmacists should become familiar with the structure and contents of the PI. 0000433644 00000 n
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As with other drug information resources, the key for effective and efficient use of the resources is user familiarity with it. Likewise, labels for select herbals, homeopathic products, and dietary supplements are also provided.Although a general Internet search for a drug’s name will likely identify a PI for the drug, the PI identified may not be the latest version and thus may lead to the use of outdated information. 0000439432 00000 n
Accessed January 8, 2015. 0000002587 00000 n
The learned intermediary doctrine was established in the case of When a patient does suffer injury from a drug treatment, the prescriber’s actions must be measured against the standard of care; that is, practice considered to be acceptable for professionals in the same field. 0000446517 00000 n
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In addition to the PIs for prescription drug products, labels are also provided for OTC products and veterinary drugs. 0000011548 00000 n
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Inject slowly over a period of at least 10 to 15 minutes. The information presented therein may be all that is necessary to accurately and completely address the question; however, other resources that provide off-label information may need to be searched as well. Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment. This package does not contain diluent. The 1966 Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing these provisions on foods, drugs, cosmetics, and medical devices.The PI is different from the Patient Package Insert (PPI), which contains information intended for patients, notwithstanding that the PPI may be required as part of the FDA-approved labeling for the drug.When the format of the PI was amended in 2006, it was the first such change since 1979, when a standard format was first promulgated by the FDA.The information included in the PI must be supported by substantial evidence. As noted earlier, drug manufacturers are required to provide guidance about the proper use of the drug, warnings about possible adverse effects, and other relevant information, in the form of the PI. 0000011420 00000 n
Following the original approval, changes to the PI may be required by the FDA based on information it gathers from mandatory industry reports to its Adverse Events Reporting System (AERS), manufacturer-submitted postmarketing studies, and/or voluntary adverse-event reports from clinicians and patients. 0000441616 00000 n
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Generic drug products are required to have the same labeling as the brand-name drug to which they were compared at the time of approval (reference listed drug [RLD]).The Code of Federal Regulations, Title 21, mandates that PIs be included with packages of prescription drugs and biologic products. 0000021738 00000 n
www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years. Copyright © 2000 - 2020 Jobson Medical Information LLC unless otherwise noted. The PI is intended for use by healthcare professionals, primarily the prescriber. In addition to being a useful tool for practice, the PI also has ramifications for state tort (liability) law. Menu. 0000004712 00000 n
As a side note, many, if not most, professional drug-information resources such as Micromedex Solutions and Clinical Pharmacology use the PI as the source of information for some of the content of their monographs. Sulfamethoxazole and trimethoprim package insert (Bactrim, Bacatrim DS, and Bactrim Pediatric; Roche—US), Rev 1/94, Rec 7/94. Promoting safe and effective drugs for 100 years. The PI is different from the Patient Package Insert (PPI), which contains information intended for patients, notwithstanding that the PPI may be required as part of the FDA-approved labeling for the drug. 0000445603 00000 n
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