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TRESIBA(insulin degludec injection), for subcutaneous
2015-11-30 10:37:52 来源: 作者: 【 】 浏览:454次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TRESIBA safely and effectively. See full prescribing information for TRESIBA.

    TRESIBA® (insulin degludec injection), for subcutaneous use
    Initial U.S. Approval: 2015
     INDICATIONS AND USAGE

    TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus (1).

    Limitations of Use:
    Not recommended for treating diabetic ketoacidosis.
    DOSAGE AND ADMINISTRATION

    Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.1, 2.2, 2.3, 2.4).
    Rotate injection sites to reduce the risk of lipodystrophy ( 2.1).
    Do not dilute or mix with any other insulin or solution ( 2.1).
    Administer subcutaneously once daily at any time of day ( 2.2).
    Do NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The TRESIBA U-100 and U-200 FlexTouch pens dose window shows the number of insulin units to be delivered and NO conversion is needed ( 2.2).
    DOSAGE FORMS AND STRENGTHS

    TRESIBA is available in the following package sizes:

    100 units/mL (U-100): 3 mL FlexTouch ® ( 3).
    200 units/mL (U-200): 3 mL FlexTouch ® ( 3).
    CONTRAINDICATIONS
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