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Idarucizumab fda approval
Idarucizumab fda approval











idarucizumab fda approval

Alternatively, may administer as two rapid consecutive infusions by hanging and infusing each vial one after another. No other infusion should be administered in parallel via the same IV access.” RATE OF ADMINISTRATIONĪdminister by bolus injection by injecting both vials consecutively one after another via syringe. The line must be flushed with NS prior to infusion. A pre-existing IV line may be used for administration. Manufacturer states, “Do not mix with other medicinal products.

idarucizumab fda approval

Once solution has been removed from the vial, administration should begin promptly or within 1 hour. Before use, the unopened vial may be kept at RT 25° C (77° F) for up to 48 hours if stored in the original package to protect from light, or up to 6 hours when exposed to light. Store unopened vials in the refrigerator at 2° to 8° C (36° to 46° F). Administer undiluted by withdrawing and injecting the contents of 2 vials with a syringe or by hanging and infusing the contents of 2 vials. DILUTIONĪ colorless to slightly yellow, clear to slightly opalescent solution available as a 2.5 Gm/50 mL injection in a single-use vial.

idarucizumab fda approval

■ ​Formal studies in patients with hepatic impairment have not been conducted. No dose adjustment is required in renally impaired patients. There are limited data to support administration of an additional 5-Gm dose of idarucizumab see Precautions. Shelly Rainforth Collins PharmD, BCGP, in Gahart's 2022 Intravenous Medications, 2022 IDARUCIZUMABĥ Gm provided as two separate vials, each containing 2.5 Gm/50 mL.













Idarucizumab fda approval