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  2. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    A package insert from 1970, with Ovrette brand contraception pills. A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the

  3. DailyMed - Wikipedia

    en.wikipedia.org/wiki/DailyMed

    DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public.

  4. Physicians' Desk Reference - Wikipedia

    en.wikipedia.org/wiki/Physicians'_Desk_Reference

    The book was distributed for free to all licensed medical doctors in America; only drugs which drug manufacturers paid to appear, appeared in the PDR, and no generic drugs were listed. The 71st Edition, published in 2017, was the final hardcover edition, weighed in at 4.6 pounds (2.1 kg) and contained information on over 1,000 drugs. [ 1 ]

  5. Boxed warning - Wikipedia

    en.wikipedia.org/wiki/Boxed_warning

    In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...

  6. Medical device - Wikipedia

    en.wikipedia.org/wiki/Medical_device

    This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...

  7. New Drug Application - Wikipedia

    en.wikipedia.org/wiki/New_Drug_Application

    The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [10] The prescribing information is widely available on the web from the FDA, [11] drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label ...

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  9. Dolutegravir - Wikipedia

    en.wikipedia.org/wiki/Dolutegravir

    Common side effects of dolutegravir in clinical trials included insomnia and headache. Serious side effects included allergic reactions and abnormal liver function in patients who were also infected with hepatitis B or C. [15] The package insert warns against a mean rise in serum creatinine of 0.11 mg/dL due to inhibition of tubular secretion of creatinine and does not affect GFR.

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