Isovue

ISOVUE is a radiographic contrast agent indicated for:

• Cerebral arteriography in adults
• Peripheral arteriography in adults
• Selective visceral arteriography and aortography in adults
• Coronary arteriography and cardiac ventriculography in adults
• Angiocardiography in pediatric patients

• Excretory urography in adults and pediatric patients
• Computed tomography (CT) of head and body in adults and pediatric patients
• Peripheral venography in adults

^†Specific concentrations are recommended for each type of imaging procedure. (

• Individualize the volume and concentration according to
  the specific dosing tables accounting for factors such as age, body
  weight, size of the vessel, and the rate of blood flow within the
  vessel. (
  2.2 Recommended Dosage for Intra-arterial Procedures in Adults

  The recommended doses for intra-arterial procedures in adults are shown in Table 1.

  Table 1: Recommended Concentrations and Volumes of ISOVUE for Intra-arterial Procedures in Adults

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume to Administer per Single Injection for Selected Injection Sites	Maximum Cumulative Total Dose
  Cerebral Arteriography	300	8 mL to 12 mL by carotid puncture or transfemoral catheterization	90 mL
  Peripheral Arteriography	300	5 mL to 40 mL into the femoral artery or subclavian artery 25 mL to 50 mL into the aorta for a distal runoff	250 mL
  Selective Visceral Arteriography and Aortography	370	Up to 10 mL for the renal arteries Up to 50 mL into the larger vessels such as the aorta or celiac artery	225 mL
  Coronary Arteriography and Cardiac Ventriculography	370	2 mL to 10 mL for selective coronary artery injection 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root	200 mL
  ,
  2.3 Recommended Dosage
  for Intravenous Procedures in Adults

  The recommended doses for intra-arterial procedures
  in adults are shown in Table 2.

  Table 2: Recommended Concentrations and Volumes of
  ISOVUE for Intravenous Procedures in Adults

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume to Administer
  Excretory Urography	250	50 mL to 100 mL by rapid injection
  	300	50 mL by rapid injection
  	370	40 mL by rapid injection
  CT of the Head	250	130 mL to 240 mL
  	300	100 mL to 200 mL
  CT of the Body	250	130 mL to 240 mL by rapid infusion or bolus injection
  	300	100 mL to 200 mL by rapid infusion or bolus injection
  	370	80 mL to 160 mL by rapid infusion or bolus injection
  Peripheral Venography	200	25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL
  ,
  2.4 Recommended Dosage in Pediatric Patients

  The recommended doses in pediatric
  patients are shown in Table 3.

  Table 3: Recommended Concentrations and Volumes per
  Body Weight of ISOVUE for Intra- arterial and Intravenous Procedures
  in Pediatric Patients

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume per Body Weight to Administer	Maximum Dose
  Intra-arterial Procedures
  Angiocardiography	370	0.5 mL/kg to 2 mL/kg per single injection	Maximum Cumulative Dose by Weight Neonates: 5 mL/kg Aged 4 weeks and older: 8 mL/kg Do not exceed maximum cumulative doses by age below. Maximum Cumulative Dose by Age <2 years 40 mL 2 years to 4 years 50 mL 5 years to 9 years 100 mL 10 years to 18 years 125 mL
  Intravenous Procedures
  Excretory Urography	250	1.2 mL/kg to 3.6 mL/kg	120 mL
  	300	1 mL/kg to 3 mL/kg	100 mL
  CT of the Head and Body	250	1.2 mL/kg to 3.6 mL/kg	120 mL
  	300	1 mL/kg to 3 mL/kg	100 mL
  )
• See full prescribing information for important dosage and
  administration information. (
  2.1 Important Dosing
  and Administration Information

  • ISOVUE is for intra-arterial or intravenous use only and
    must not be administered intrathecally
    [see Warnings and Precautions
    ]
    .
  • Specific concentrations of ISOVUE are recommended for each
    type of imaging procedure
    [see Dosage and Administration ]
    .
  • Individualize the volume, concentration, and injection rate
    of ISOVUE according to the specific dosing tables
    [see Dosage
    and Administration ]
    . Consider factors such as: age, body weight, blood vessel
    size and blood flow rate, anticipated pathology and degree and extent
    of opacification required, structures or area to be examined, concomitant
    medical conditions, imaging equipment, and technique to be employed.
  • Hydrate patients before and after ISOVUE administration
    [see Warnings and Precautions ]
    .
  • Use aseptic technique for all handling and administration
    of ISOVUE.
  • ISOVUE may be administered at either body temperature (37°C,
    98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F).
  • Visually inspect ISOVUE for particulate matter or discoloration
    before administration. Do not administer ISOVUE if particulate matter
    or discolorations are observed.
  • Do not mix ISOVUE with other drugs or inject in intravenous
    lines containing other drugs or total nutritional admixtures.
  • ISOVUE single-dose containers are intended for one procedure
    only. Discard any unused portion.
  )

Injection: Clear, colorless
to pale yellow solution available in the following concentrations
of iodine:

Lactation: A lactating woman may
pump and discard breast milk for 10 hours after ISOVUE administration.
(