U.S Spect products | Others

Indium In 111 Chloride Sterile Solution

This information is intended for U.S. healthcare professionals only.

Product information

Indium In 111 Chloride Sterile Solution is supplied as a sterile, non-pyrogenic solution of Indium In 111 Chloride in 0.05 molar hydrochloric acid. No carrier has been added to the solution. Each 0.5 milliliter of the solution contains 185 megabequerels (5 milli curies) of Indium In 111 Chloride at time of calibration (specific activity of >1.85 GBq/μg Indium; >50 mCi/μg Indium at this time of calibration). The solution pH is 1.1 to 1.4.

Indication & 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 Radioimmuno therapy 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.

Frequently asked questions

Expiration is three days post calibration at 6:00 p.m. CT.

The vial size is 10 mL.

The volume is 0.5 mL.

The concentration is 10 mCi/mL at time of calibration.

No, this product is not indicated for that use and should not be used in that way.

Call Curium Pharmacovigilance / Product Monitoring Department at 866.789.2211

How is this product supplied

Distribution

Direct

Calibration date

Friday of each week

Expiration

Monday following calibration

Storage conditions

Controlled room temperature 20° to 25°C (68° to 77°F)

Order information

Description Qty Unit Size Order # NDC
Indium In 111 Chloride Sterile Solution – 5 mCi/vial 1 Each 0.5 mL N132F0 69945-132-06

Product contact information

Maryland Heights

N/A