NOVOLOG

NOVOLOG- insulin aspart injection, solution
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

NOVOLOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Always check insulin labels before administration [see Warnings and Precautions ( 5.4)] .
  • Inspect NOVOLOG visually before use. It should appear clear and colorless. Do not use NOVOLOG if particulate matter or coloration is seen.
  • Use NOVOLOG FlexPen and NOVOLOG FlexTouch with caution in patients with visual impairment who may rely on audible clicks to dial their dose.Use NOVOLOG FlexPen and NOVOLOG FlexTouch with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
  • Use PenFill cartridges with caution in patients with visual impairment.Use PenFill cartridges with caution in patients with visual impairment.
  • Do NOT mix NOVOLOG with other insulins when administering using a continuous subcutaneous infusion pump.

2.2 Route of Administration

Subcutaneous Injection

  • Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
  • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions ( 6.1)].
  • The NOVOLOG FlexPen and FlexTouch dial in 1-unit increments. The NOVOLOG FlexPen and FlexTouch dial in 1-unit increments.
  • NOVOLOG administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.
  • NOVOLOG may be diluted with Insulin Diluting Medium for NOVOLOG for subcutaneous injection. Diluting one part NOVOLOG to nine parts diluent will yield a concentration one-tenth that of NOVOLOG (equivalent to U-10). Diluting one part NOVOLOG to one part diluent will yield a concentration one-half that of NOVOLOG (equivalent to U-50).

Continuous Subcutaneous Infusion (Insulin Pump)

  • Use NOVOLOG in pump systems specifically indicated for insulin infusion.Use NOVOLOG in pump systems specifically indicated for insulin infusion.
  • Train patients using continuous subcutaneous insulin fusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
  • Administer NOVOLOG by continuous subcutaneous infusion into the subcutaneous tissue of the abdominal wall. Rotate infusion sites within the same region to reduce the risk of lipodystrophy [see Adverse Reactions ( 6.1)] .
  • Follow healthcare provider recommendations when setting basal and meal time infusion rate.
  • Change the NOVOLOG in the reservoir at least every 6 days. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions.Change the NOVOLOG in the reservoir at least every 6 days. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions.
  • Change the infusion set and the infusion set insertion site at least every 3 days. Change the infusion set and the infusion set insertion site at least every 3 days.
  • Do NOT dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.Do NOT dilute or mix NOVOLOG when administering by continuous subcutaneous infusion.
  • Do NOT expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration

  • Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. NOVOLOG is stable in infusion fluids such as 0.9% sodium chloride.
  • Administer NOVOLOG intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3, 5.6) and How Supplied/Storage and Handling ( 16.2)] .

2.3 Dosage Information

  • Individualize and adjust the dosage of NOVOLOG based on route of administration, the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal.
  • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2, 5.3) and Use in Specific Populations ( 8.6, 8.7)] .
  • Dosage adjustment may be needed when switching from another insulin to NOVOLOG [see Warnings and Precautions ( 5.2)] .

2.4 Dosage Adjustment Due to Drug Interactions

  • Dosage adjustment may be needed when NOVOLOG is coadministered with certain drugs [see Drug Interactions (7)] .

2.5 Instructions for Mixing with Other Insulins

NOVOLOG subcutaneous injection route

  1. NOVOLOG may be mixed with NPH insulin preparations
  2. ONLY.

• If NOVOLOG is mixed with NPH insulin, draw NOVOLOG into the syringe first and inject immediately after mixing.

NOVOLOG continuous subcutaneous infusion route (Insulin Pump)

Do NOT mix NOVOLOG with any other insulin.

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