Package insert definition

Package insert means an accompanying written or printed paper consisting of product information inserted in product pack or container.

Package insert means any printed information supplied with the container or primary pack.

Package insert means (a) any display of written, printed or graphic matter affixed upon the immediate container, outside container, wrapper or other packaging of any Finished Product or (b) any written, printed or graphic material on or within the package from which any Finished Product is to be dispensed.

Examples of Package insert in a sentence

• More information on the test product can be found in the IB; information on the control product can be found in the Package Insert.

• Plasma protein binding is independent of concentration over the concentration range achieved clinically with the recommended doses (Cystagon® Package Insert, 2007).

• In some patients with poorer tolerability for Cystagon®, patients may still receive benefit with a white blood cell cystine level of less than 2 nmol ½ cystine/mg protein” (Cystagon® Package Insert, 2007).

• Although there is no explicit reference in the Cystagon® Package Insert as to which protein assay should be used to determine that the cystine level is less than 1 nmol ½ cystine/mg protein, the first laboratories known for measuring WBC cystine, have used the Xxxxx assay, which makes the Xxxxx assay as the method of reference, by default.

• With time, most organs are damaged, including the retina, muscles and central nervous system (Cystagon® Package Insert, 2007).

More Definitions of Package insert

Package insert means the official labeling information sheet that accompanies a prescription drug when it is distributed by the manufacturer.

Package insert means an FDA approved document which provides essential information about an approved drug.

Package insert means the written material accompanying cells and / or tissue allograft or autograft bearing further information about the cells and / or tissue, directions for use, and any applicable warnings;

Package insert means a piece of paper or any material that conveys a meaning through the use of any statement about a product that has been inserted, included or displayed on herbal product containers or packages;

Package insert means a pamphlet on which is printed the particulars as prescribed in regulation 10;

Package insert means documentation supplied by the Manufacturer and included with the packaging of the Products.

Package insert. (說明書) means any leaflet, notification or other written material supplied with the package of a proprietary Chinese medicine to provide information in respect of the proprietary Chinese medicine, but does not include a label;