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TRESIBA® (insulin degludec injection)
2015-10-26 07:11:43 来源: 作者: 【 】 浏览:380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

    During episodes of hypoglycemia ( 4).
    Hypersensitivity to TRESIBA or one of its excipients ( 4).

    WARNINGS AND PRECAUTIONS
    Never share a TRESIBA FlexTouch pen between patients, even if the needle is changed ( 5.1).
    Hyper- or hypoglycemia with changes in insulin regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring ( 5.2).
    Hypoglycemia: May be life-threatening. Increase monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness (
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