TECHNESCAN MAG3 Powder for solution for injection (2019)

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Curium US LLC

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Instructions for Use

INSTRUCTIONS FOR THE PREPARATION OF TECHNETIUM Tc 99m MERTIATIDE <b>Note:</b> Read complete directions thoroughly before starting preparation procedure. Procedural Precautions and Notes Solutions of sodium ...

1. Description

Technescan MAG3 is a kit for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide ...

2. Clinical Pharmacology

Following intravenous injection of technetium Tc 99m mertiatide, the appearance, concentration, and excretion of the tracer in the kidney can be monitored to assess renal function. Although technetium ...

3. Indications and Usage

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. ...

4. Contraindications

None known.

5. Warnings

None known.

6.1. General

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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females.

6.7. Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with technetium Tc 99m mertiatide. It is also not known whether this drug can cause fetal harm when administered to a pregnant ...

6.9. Nursing Mothers

Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients under the age of 30 days have not been established.

7. Adverse Reactions

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

10. Dosage and Administration

The suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is ...

11. How Supplied

Catalog Number 096. Technescan MAG3 is supplied as a lyophilized powder packaged in vials. Each reaction vial contains 1 mg betiatide, 0.05 mg (minimum) stannous chloride dihydrate (SnCl<sub>2</sub>•2H ...

12. Storage and Handling

Technescan MAG3 should be stored at controlled room temperature 20° to 25°C (68° to 77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15° to 30°C) and ...