package insert


Also found in: Thesaurus, Medical, Legal, Financial, Acronyms, Encyclopedia, Wikipedia.
Translations

package insert

n (pharm) prospecto (del envase), hoja de información (que acompaña un medicamento)
Mentioned in ?
References in periodicals archive ?
These drugs manufactured by pharmaceutical companies contain information about the drugs in them in the form of package insert (PI) as mandated in the Drugs and Cosmetics Rules (1945).
However, according to the package insert, no dosage adjustments are needed.
The primary source of drug information is a Package Insert.
But the package insert for the vaccine lists a lot of adverse events.
Thirty of 39 reports (77%) did not have an explanation for the error; for those that did, reasons included misinterpreting package insert instructions, confusing the RV1 oral applicator syringe with a syringe for injection, confusing the RV1 vial with a vial used for injectable vaccine, inadequate training, and not reading the package insert.
The package insert for warfarin contains information on CYP2C9 and VKORC1, as well as a detailed genotype-guided dosing chart that performs better than the standard of care in selecting a patient's therapeutic warfarin dose [11].
The publication in a package insert of a biologically plausible mechanism of action--a mechanism that has not been shown to be clinically relevant--says more about the continuing inadequacy of package inserts and the manner in which they are developed than it does about the abortifacient nature of the IUD.
However, it emerged from documentation that the MCC took 20 months to respond to the Cipla application to amend their Mefliam package insert to reflect additional information.
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 package insert for the tumor necrosis factor inhibitor etanercept has been updated to include a black box warning on risk of infection, according to an announcement from Amgen Inc.
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 electronic capability aspects of the new package insert requirements are one of the most "potentially exciting opportunities" created by the new system, he said, adding that the electronic information will allow physicians to access the most up-to-date prescribing information at the point of care.