Meanings of package insert in English

Amgen said the side effects are already included in the drug's package insert label.

The same dangers were previously printed in bold-face type in Enbrel's package insert label.

The same dangers have previously been printed in bold-face type in Enbrel's package insert label.

Every prescription drug comes with what is called a drug information insert or package insert.

Spectrum said the FDA did not request any changes to the currently approved indications and package insert.

Background and Purpose- The 2015 updated US Food and Drug Administration alteplase package insert altered several contraindications.

For new drugs, the information listed on the package insert comes primarily from FDA-required studies on the drug.

The package insert for IFX recommends that maintenance therapy be prescribed for patients who respond to induction therapy.

According to the package insert, Anadrol (oxymetholone) is an anabolic steroid, a synthetic derivative of testosterone.

Conclusion: This study found that testicular doses from Zevalin were much lower than that originally reported in the package insert.

Mylotarg's package insert label in the United States says the drug was approved based on its ability to shrink tumors.

An indication on the drug package insert that no negative effects have been found does not mean there aren't any.

Tysabri's package insert label cautions that patients taking the drug have a 1-in-1,000 risk of developing PML.

It said safety risks are noted in the product's package insert label and that cardiac monitoring is suggested in patients with cardiac risk factors.

Genzyme, based in Cambridge, Massachusetts, said data from the four-year North American study was recently added to the package insert label of the drug.

The drugs' makers have also added risk of heart attack, stroke, or sudden death in people with undiagnosed heart problems to their package inserts.