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Technescan MAG3™ Kit for the Preparation of Technetium Tc 99m Mertiatide

INDICATIONS AND USAGE

Technescan MAG Kit for the Preparation of Technetium Tc 99m Mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients over the age of 30 days.  It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

  • The contents of this kit are not radioactive. However, after sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained.
  • Contents of the reaction vial are intended only for use in the preparation of technetium Tc 99m mertiatide and are NOT to be administered directly to the patient.
  • To help reduce the radiation dose to the bladder, as well as other target organs, the patient should increase his or her fluid intake (unless medically contraindicated) and void as often as possible after the injection of technetium Tc 99m mertiatide for six hours after the imaging procedure.
  • Technetium Tc 99m mertiatide should not be used more than six hours after preparation.
  • It is essential that the user follow the directions carefully and use aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers during the addition of pertechnetate solution and the withdrawal of doses for patient administration.
  • The technetium Tc 99m labeling reactions involved in preparing Technescan MAG3 depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m may adversely affect the quality of the radiopharmaceutical. Therefore, sodium pertechnetate Tc 99m containing oxidants should not be employed.
  • Care should be taken to insure minimum radiation exposure to the patient and to occupational workers.
  • Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

ADVERSE REACTIONS

The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.

USE IN SPECIFIC POPULATIONS

  • Safety and effectiveness in pediatric patients under the age of 30 days have not been established.
  • Breastfeeding: should be discontinued because Technetium Tc 99m is excreted in human milk.

How Supplied

Distribution Direct
Expiration Reconstituted product: 6 hours
Shelf Life Kit: One year post manufacture. After reconstitution: 6 hours
Storage Conditions Kit: Controlled room temperature 20°C to 25°C (68-77°F) and protected from light until use. Reconstituted product: Room temperature (15°C-30°C)

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Kit, 5-vial 1 each 10 mL N096B0 00019909620

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What is the expiration date of the kit?The expiration date is one year after date of manufacture.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.