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package insert

com., farmac., IT prospecto m
embal. forro m; forro de un embalaje; revestido
 Inglés tesauro
package insert
med. Drug prescribing information prepared by the drug manufacturer and approved by the Food and Drug Administration FDA. The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug. The package insert is included with drug packaging and is used to develop any promotional or labeling materials. véase también food and drug administration
Package Insert medications
abrev. PI (Alex Lilo)