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package insert

   Also found in: Acronyms, Wikipedia 0.01 sec.
package insert,
a leaflet that, by order of the Food and Drug Administration, must be placed inside the package of every prescription drug. The leaflet must include the trademark for the drug, its generic name, and its mechanism of action; state its indications, contraindications, warnings, precautions, adverse effects, and dosage forms; and include instructions for the recommended dose, time, and route of administration.

package insert
Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific information–eg, indications for use; forms of administration, side effects, etc; it is more cynically described as a hard-to-handle and difficult-to-read package 'stuffer' printed in Lilliputian type on Bible paper. Cf Advertising.


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Manufacturers of this electronic cigarette around the world have included WHO's name or logo, for example on their website, on package inserts or on advertisements," Bettcher said, without naming any company or manufacturer.
This is because the control limits will be too wide; values that are used to establish the standard deviation in the package insert reflects the variation observed in the many different laboratories that were used to help establish the values listed in the package insert.
The same dangers were previously printed in boldface type in Enbrel's package insert label.
 
 
 
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