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Значения термина package insert на английском
Material affixed to a container or article with printed information.
Похожие термины
Document accompanying a medication.
Использование термина package insert на английском
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Amgen said the side effects are already included in the drug's package insert label.
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The same dangers were previously printed in bold-face type in Enbrel's package insert label.
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The same dangers have previously been printed in bold-face type in Enbrel's package insert label.
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Every prescription drug comes with what is called a drug information insert or package insert.
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Spectrum said the FDA did not request any changes to the currently approved indications and package insert.
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Background and Purpose- The 2015 updated US Food and Drug Administration alteplase package insert altered several contraindications.
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For new drugs, the information listed on the package insert comes primarily from FDA-required studies on the drug.
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The package insert for IFX recommends that maintenance therapy be prescribed for patients who respond to induction therapy.
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According to the package insert, Anadrol (oxymetholone) is an anabolic steroid, a synthetic derivative of testosterone.
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Conclusion: This study found that testicular doses from Zevalin were much lower than that originally reported in the package insert.
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Mylotarg's package insert label in the United States says the drug was approved based on its ability to shrink tumors.
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An indication on the drug package insert that no negative effects have been found does not mean there aren't any.
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Tysabri's package insert label cautions that patients taking the drug have a 1-in-1,000 risk of developing PML.
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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.
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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.
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The drugs' makers have also added risk of heart attack, stroke, or sudden death in people with undiagnosed heart problems to their package inserts.