Insulin premix formulation and product, methods of preparing same, and methods of using same

作者: Lee Sarah Elizabeth , Wong Joseph Chung Tak

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摘要: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of for intravenous administration and preferably further a tonicity adjuster. The methods making using such are also provided. may be aseptically filled into flexible container assembly to form pharmaceutical product. product can sterile ready-to-use aqueous solution glycemic control in an individual with metabolic disorders through infusion. is unexpectedly stable when freshly prepared during its shelf-life storage at refrigeration temperatures 2° C. 5° 24 months followed by additional 30 days room 23° 27° C., even without any added preservative, zinc, surfactant or other stabilizing excipient.

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