Bayer Healthcare, Inc.

Bayer Healthcare, Inc. Drugs

• Vasovist
  

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  Vasovist

  

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  2.1 Dosing Guidelines

  Administer VASOVIST as an intravenous bolus injection, manually or by power injection, at a dose of 0.12 mL/kg body weight (0.03 mmol/kg) over a period of time up to 30 seconds followed by a 25-30 mL normal saline flush. (See Table 1 for weight-adjusted dose volumes).

  TABLE 1. Weight-Adjusted Volumes for the 0.03 mmol/kg Dose Body Weight Volume Kilograms (kg) Pounds (lb) Milliliters (mL) 40 88 4.8 50 110 6.0 60 132 7.2 70 154 8.4 80 176 9.6 90 198 10.8 100 220 12.0 110 242 13.2 120 264 14.4 130 286 15.6 140 308 16.8 150 330 18.0 160 352 19.2

  Inspect the VASOVIST vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.

  VASOVIST is intended for single use only and should be used immediately upon opening. Discard any unused portion of the VASOVIST vial.

  Do not mix intravenous medications or parenteral nutrition solutions with VASOVIST. Do not administer any other medications in the same intravenous line simultaneously with VASOVIST.

  2.2 Imaging Guidelines

  VASOVIST imaging is completed in two stages: the dynamic imaging stage and the steady-state imaging stage. Both stages are essential for adequate evaluation of the arterial system, and dynamic imaging always precedes steady-state imaging. During interpretation of the steady-state images, VASOVIST within the venous system may limit or confound the detection of arterial lesions.

  To assess the initial distribution of VASOVIST within the arterial system, begin dynamic imaging immediately upon injection. Begin steady state imaging after dynamic imaging has been completed, generally 5 to 7 minutes following VASOVIST administration. At this time point, VASOVIST is generally distributed throughout the blood. In clinical trials, steady-state imaging was completed within approximately one hour following VASOVIST injection.

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