package insert


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Translations

package insert

n (pharm) prospecto (del envase), hoja de información (que acompaña un medicamento)
English-Spanish/Spanish-English Medical Dictionary Copyright © 2006 by The McGraw-Hill Companies, Inc. All rights reserved.
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References in periodicals archive ?
Ingredients in different vaccines vary by manufacturer and can change from year to year, so reading the vaccine package insert is the best way to determine which ingredient to test.
The findings suggest that continued monitoring for neurologic events--such as Guillain-Barre syndrome, which was reported in two cases--is warranted, as is closer attention to the package insert, given the high proportion of vaccine administration errors and use of the vaccine in persons for whom it is not indicated, the investigators concluded.
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The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.
Lactic acidosis can occur as a complication of therapy with Zerit (stavudine, d4T) in HIV-infected patients, according to a warning letter sent in February and a labeling and package insert revision made in March.
New language has been added to the package insert saying postmarketing reports have described case of hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to over 20 times the upper limit of normal with or without jaundice, reflecting a mixed or hepatocellular pattern of liver injury.
A warning about the risks has also been added to the package insert.
The package insert for amitriptyline advises doctors to carefully monitor patients with cardiovascular disorders and notes that the medication can cause cardiac arrhythmias, sinus tachycardia, myocardial infarction, and stroke, as well as both elevated and depressed blood sugar levels.
The Food and Drug Administration and the drug's manufacturer, Bristol-Myers Squibb Co., agreed to strengthen the warnings, contraindications, and precaution sections of the package insert following postmarketing reports of liver failure resulting in transplantation or death.
A boxed warning on the product label, based on 84 cases of tuberculosis associated with the drug since 1998, states that patients should be tested for latent TB infection prior to therapy A warning about the risks has been added to the package insert.
TUESDAY, April 17, 2018 (HealthDay News) -- Messages relating to safe storage and disposal of prescription opioids are inconsistent and are often not included on package insert information, according to a research letter published online April 17 in the Annals of Internal Medicine.