Technescan Mag3

Name: Technescan Mag3

Commonly used brand name(s)

In the U.S.

  • Technescan Mag3

Available Dosage Forms:

  • Kit

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Technescan Mag3 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known
  • Difficult or labored breathing
  • fever
  • nervousness
  • pounding in the ears
  • seizures
  • shaking chills
  • slow or fast heartbeat
  • tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Headache
  • itching or rash
  • nausea
  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

TechneScan MAG3 - 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 Tc 99m mertiatide is highly plasma protein bound following intravenous injection, the protein binding is reversible and the tracer is rapidly excreted by the kidneys via active tubular secretion and glomerular filtration. Following intravenous injection of technetium Tc 99m mertiatide in normal volunteers, 89% of the tracer was plasma protein bound. In healthy subjects with normal renal function (mean serum creatinine 1.2 mg/dL) technetium Tc 99m mertiatide was rapidly cleared from the blood. The plasma clearance was approximately 0.3 liters/minute and the amount of technetium Tc 99m mertiatide excreted in the urine in three hours was nearly 90% of the dose. In a study performed in three patients with renal impairment (serum creatinine greater than 6.3 mg/dL), there was decreased blood clearance and a decrease in the amount excreted in the urine over three hours. In these patients, 78% of the tracer was plasma protein bound after intravenous injection. The mean plasma clearance of technetium Tc 99m mertiatide was 0.03 liters/minute and 21.3% was excreted in three hours on average. In both healthy subjects and patients with renal impairment, the plasma concentration-time profile showed a biexponential decline.

Indications and Usage for TechneScan MAG3

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. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

Warnings

None known.

Radiation dosimetry

The estimated absorbed radiation doses from an intravenous administration of technetium Tc 99m mertiatide are presented in Table 4.

Storage

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 must be used within six hours of preparation.

Table 4. Radiation Dose Estimates for Tc 99m Mertiatide

*Calculated by Oak Ridge Associated Universities, based upon the pediatric phantom series of Christy and Eckerman of Oak Ridge National Laboratories. The adult radiation absorbed doses were calculated based on data from ten normal volunteers using the Medical Internal Radiation Dose Committee (MIRD) schema.

**Radioactive doses for 1-, 5-, and 10-year olds are based on a maximum dose of 7.4 MBq/kg (200 μCi/kg).

8-day Old 1-year Old** 5-year Old** 10-year Old** 15-year Old Adult
Assumed Weight (kg) 3.4 9.8 19 32 57 70
Tc 99m Mertiatide Dose 37 MBq
(1 mCi)
72.52 MBq
(1.96 mCi)
140.6 MBq
(3.8 mCi)
236.8 MBq
(6.4 mCi)
370 MBq
(10 mCi)
370 MBq
(10 mCi)
Organ mSv rem mSv rem mSv rem mSv rem mSv rem mSv rem
Gallbladder Wall 2.701 0.27 2.466 0.235 1.547 0.160 1.658 0.166 1.961 0.200 1.628 0.160
Lower Large Intestine Wall 1.739 0.17 1.595 0.161 2.250 0.220 2.368 0.237 4.070 0.400 3.256 0.330
Small Intestine 0.518 0.052 0.5439 0.055 1.195 0.122 1.397 0.141 2.035 0.200 1.628 0.160
Upper Large Intestine Wall 0.962 0.096 0.943 0.096 1.828 0.186 2.0365 0.205 2.442 0.250 1.887 0.190
Kidneys 1.406 0.14 1.088 0.112 1.308 0.129 1.5155 0.154 1.739 0.180 1.443 0.140
Liver 0.3219 0.032 0.3046 0.031 0.394 0.038 0.4262 0.0435 0.481 0.048 0.3626 0.036
Ovaries 0.592 0.058 0.6164 0.061 1.322 0.133 1.5392 0.154 3.330 0.330 2.5900 0.260
Red Marrow 0.1628 0.016 0.1595 0.0161 0.281 0.0277 0.3552 0.0352 0.629 0.063 0.4810 0.050
Testes 0.518 0.051 0.5294 0.053 1.0826 0.110 1.1840 0.122 2.368 0.240 1.628 0.160
Urinary Bladder Wall 11.470 1.1 9.428 0.921 21.090 2.090 23.680 2.368 59.20 6.00 48.1000 4.80
Total Body 0.2405 0.024 0.2176 0.022 0.3656 0.0365 0.4026 0.0410 0.814 0.081 0.6660 0.065

INSTRUCTIONS FOR THE PREPARATION OF TECHNETIUM Tc 99m MERTIATIDE

Note: Read complete directions thoroughly before starting preparation procedure.

Procedural Precautions and Notes

  1. Solutions of sodium pertechnetate Tc 99m which contain oxidizing agents (i.e., sodium hypochlorite or hydrogen peroxide) should not be used.
    NOTE: Do not use Tc 99m eluate more than 6 hours after its elution from the generator.
  2. All transfers and vial stopper entries must be done using aseptic technique.
  3. The water bath used for heating the contents of the reaction vial must be at a continuous rolling boil during the heating step of the preparation procedure. The vial should be in direct contact with the rolling boil water of the bath, and the level of the bath must be at least even with the level of the contents of the vial.
  4. The temperature of a lead incubation shield should be allowed to reach the temperature of the water bath before incubating the reaction vial. The shield should be designed so that water flows through the interior of the shield.

Note 1: Wear waterproof gloves during the entire preparation procedure and during subsequent patient dose withdrawals from the reaction vial.

Note 2: Make all transfers of sodium pertechnetate Tc 99m solution during the preparation procedure with an adequately shielded syringe.

Note 3: Keep the radioactive preparation in the lead shield described below (with cap in place) during the useful life of the radioactive preparation. Maintain adequate shielding during the life of the product and use a shielded, sterile syringe for withdrawing and injecting the preparation.

Procedure for the Preparation of Technetium Tc 99m Mertiatide

  1. Prepare a rolling boil water bath containing a vial shield with openings cut in it to allow the water to circulate through the shield. The openings should be oriented to prevent radiation leakage.
  2. Place the reaction vial in a lead dispensing shield fitted with a lid and with a minimum wall thickness of 1/8 inch.
  3. Swab the rubber stopper of the reaction vial with an appropriate antiseptic. Insert a filter-containing venting needle (provided) through the vial stopper. Inject 4 to 10 milliliters of sodium pertechnetate Tc 99m solution containing 740 megabecquerels (20 mCi) to 3.70 gigabecquerels (100 mCi) into the vial. If required, use nonbacteriostatic normal saline to dilute the sodium pertechnetate Tc 99m solution to the desired concentration prior to addition to the vial.
    NOTE: Make sure the water bath is at boiling temperature before adding sodium pertechnetate Tc 99m to the reaction vial.
  4. Immediately following the addition of sodium pertechnetate Tc 99m solution to the reaction vial, withdraw the syringe plunger to a volume of 2 mL, thus removing 2 mL of argon gas and adding 2 mL of filtered air to the vial. The air is required to oxidize excess stannous ion. Remove both needles from the vial.
    NOTE: The addition of 2 mL air is required to prevent the progressive formation of technetium Tc 99m labeled impurities.
  5. Invert the reaction vial several times to obtain complete mixing.
  6. Immediately transfer the reaction vial to the water bath. Place it inside the lead shield which has been equilibrated to the temperature of the boiling water bath. Allow the reaction vial to incubate for 10 minutes.
    NOTE: The reaction vial MUST be placed in the boiling water bath within 5 minutes of the addition of sodium pertechnetate Tc 99m solution.
  7. Remove the reaction vial from the boiling water bath and place in the lead dispensing shield. Allow the contents of the vial to cool for approximately 15 minutes to reach body temperature. Using proper shielding, the vial contents should be visually inspected.
    The solution should be clear and free of particulate matter. If not, the preparation should not be used.
  8. Assay the reaction vial using a suitable radioactivity calibration system. Record the date, time, total technetium Tc 99m activity, volume, and technetium Tc 99m concentration on the radioassay information label and affix the label to the lead dispensing shield.
  9. The radiochemical purity of the reconstituted solution must be checked prior to administration to the patient. If the radiochemical purity is less than 90%, the product must not be used.
  10. Store the reaction vial containing the technetium Tc 99m mertiatide at room temperature (15° to 30°C) until use. The technetium Tc 99m mertiatide preparation must be used within six hours of preparation.
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