Ultravist

Ultravist Manufacturers

• Bayer Healthcare Pharmaceuticals Inc.
  

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  Ultravist | Ursh Pharmaceutical Inc.

  

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  Directions

  adults and children over 12 years:

  -remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

  -carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

  -once exposed portion of patch is positioned, carefully remove remaining backing to completely

  apply patch to affected area

  -wear one Icy Hot Patch up to 8 hours

  -repeat as necessary, but no more than 3 times daily

  children under 12 years or younger:  ask a doctor
  

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• Bayer Healthcare Pharmaceuticals Inc.
  

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  Ultravist | Bayer Healthcare Pharmaceuticals Inc.

  

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  • Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST if particulate matter and/or discoloration is observed. • Determine the volume and concentration of ULTRAVIST Injection to be used taking into account factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Specific dose adjustments for age, gender, weight and renal function have not been studied for ULTRAVIST Injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of ULTRAVIST Injection below doses recommended has not been established. • The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients. • Hydrate patients adequately prior to and following the administration of ULTRAVIST. [See Warnings and Precautions (5.2).] 2.1 Intra-Arterial Procedures

  The volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined. Inject contrast at rates approximately equal to the flow rate in the vessel being injected.

  • Cerebral Arteriography (300 mg I/mL), Coronary Arteriography and Left Ventriculography (370 mg I/mL), Peripheral Arteriography (300 mg I/mL): see Table 1. • Aortography and Visceral Angiography (370 mg I/mL):   Use a volume and rate of contrast injection proportional to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. Do not exceed 225 mL as total dose for the procedure.

  Table 1: Suggested Single Injection Doses for Adult Intra-Arterial Procedures

  Cerebral Arteriography

  (300 mg I/mL)

  Peripheral Arteriography

  (300 mg I/mL)

  Coronary Arteriography and Left Ventriculography

  (370 mg I/mL)

    Intra-Arterial Injection Sites

  Carotid Arteries

  Vertebral Arteries

  Aortic Arch Injection (4 vessel study)

  3–12 mL

  4–12 mL

  20–50 mL

  -

  -

  -

  -

  -

  -

  Right Coronary Artery

  Left Coronary Artery

  Left Ventricle

  -

  -

  -

  -

  -

  -

  3–14 mL

  3–14 mL

  30–60 mL

  Subclavian or Femoral Artery

  Aortic Bifurcation (distal runoff)

  -

  -

  5–40 mL

  25–50 mL

  -

  -

  Maximum Total Dose

  150 mL

  250 mL

  225 mL

  2.2 Intravenous Procedures • Peripheral Venography (240 mg I/mL):   Inject the minimum volume necessary to visualize satisfactorily the structures under examination. Do not exceed 250 mL as total dose for the procedure. • Contrast Computed Tomography (CT) (300 mg I/mL and 370 mg I/mL) and Excretory Urography (300 mg I/mL): see Table 2.

  Table 2: Suggested ULTRAVIST Injection Dosing for Adult Intravenous Contrast Administration

  Excretory Urography (300 mg I/mL)

  Contrast Computed Tomography (300 mg I/mL)

  Contrast Computed Tomography (370 mg I/mL)

  Excretory Urography

  Approximately 300 mg I/kg body wt. (Adults with normal renal function)

  -

  -

  Head

  -

  50–200 mL

  41–162 mL

  Body

  Bolus Injection

  50–200 mL

  41–162 mL

  Rapid Infusion

  100–200 mL

  81–162 mL

  Maximum Total Dose

  100 mL

  200 mL (60 g iodine)

  162 mL (60 g iodine)

  2.3 Pediatric Dosing

  The recommended dose in children over 2 years of age for the following evaluations is:

  • Intra-arterial:

  Cardiac chambers and related arteries (370 mg I/mL):

  Inject 1 to 2 milliliters per kilogram (mL/kg). Do not exceed 4 mL/kg as total dose.

  • Intravenous:

  Contrast Computerized Tomography or Excretory Urography (300 mg I/mL):

  Inject 1 to 2 mL/kg. Do not exceed 3 mL/kg as total dose.

  The safety and efficacy relationships of other doses, concentrations or procedures have not been established [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].

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