package insert


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package insert

n (pharm) prospecto (del envase), hoja de información (que acompaña un medicamento)
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References in periodicals archive ?
Creating the Ideal Package Insert (PI) is a highly labor-intensive and collaborative process that requires a thoughtful approach and expertise from industry stakeholders.
Cipla Medpro said their request for a new package insert was made in October 2002, after the company was alerted to a Medinfo press release entitled 'Suicide alert issued on malaria drug'.
Other package insert updates include the addition of reported TB incidence in clinical studies in the adverse reactions section.
Prescription drug package inserts will soon have a new format that U.
For these reasons, the purpose of package insert information (whether in the form of product information, prescribing information, or PDR entry) and its relation to the practice of medicine needs to be understood and communicated to the court and jury throughout the defense of a claim that centers on the use of a medication.
Schilling's attorney, Dennis Larry, said the package insert on his client's prescription contained the words "not recommended" rather than "not approved" for acute or post-operative pain--a distinction he contends is significant.
announced the revision of the package insert for the oral androgen receptor signaling inhibitor XTANDI Capsules 40mg.
Prescribers and users of these products should check the ingredients and review the revised package insert and patient information leaflet before prescribing or using promethazine-containing products.
13 letter announcing that reports of self-injury and delirium in patients taking Tamiflu had been added to the precautions section of the product's package insert.
The author apparently uses Beckman Coulter hematology analyzers, which--like all automated hematology analyzers--have control materials that contain a package insert with assayed ranges.
The Dosage and Administration section of the amprenavir package insert was revised to include the following statement:
The most common reported adverse reaction expressed in a pool of 2,606 patients was inflammation of the skin around the injected area and an increase in pain, according to Kineret's package insert.