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Indium In 111 Chloride Sterile Solution

INDICATIONS AND USAGE

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information on the final drug product.

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

  • Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

WARNINGS AND PRECAUTIONS

  • CONTENTS OF THE VIAL OF INDIUM In 111 CHLORIDE SOLUTION ARE INTENDED ONLY TO BE USED AS AN INGREDIENT FOR RADIOLABELING PROSTASCINT FOR USE IN IN VIVO DIAG NOSTIC IMAGING PROCEDURES OR TO BE USED AS AN INGREDIENT FOR RADIOLABELING ZEVALIN™ FOR USE IN RADIOIMMUNOTHERAPY PROCEDURES, AND ARE NOT TO BE ADMINISTERED DIRECTLY TO HUMANS.
  • Caution must be used to maintain proper aseptic technique while withdrawing and transferring contents of the Indium Chloride solution vial.
  • Do not use after expiration time and date indicated on vial label.
  • Contents of the vial are radioactive and adequate shielding and handling precautions must be maintained at all times.

ADVERSE REACTIONS

  • Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

USE IN SPECIFIC POPULATIONS

  • Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

How Supplied

Distribution Direct
Calibration Day Friday of each week
Expiration Refer to ProstaScint and/or Zevalin package inserts
Shelf Life Monday following calibration
Storage Conditions Controlled room temperature at 20° to 25°C (68° to 77°F)

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Vial, 5 mCi activity 1 each 0.5 mL N132F0 00019913206

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What is the expiration date and time for indium in111 chloride sterile solution?Expiration is three days post calibration at 6:00 p.m. CT.
What is the size of the vial?The vial size is 10 mL.
What is the volume of the solution?The volume is 0.5 mL.
What is the concentration of the solution?The concentration is 10 mCi/mL at time of calibration.
Can this product be used to label the Octreoscan kit for the preparation of indium in-11 pentreotide?No, this product is not indicated for that use and should not be used in that way.
Who do I contact for additional sfety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.