technescan mag3 (Mertiatide) injection, powder, lyophilized, for solution
Diagnostic-For Intravenous Use
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 (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N',N”,S']oxotechnetate (2-)) which is formed is suitable for intravenous administration.
Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl2•2H2O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl2•2H2O), 40 milligrams sodium tartrate dihydrate (Na2C4H2O6•2H2O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas:
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging is listed in Table 1.
|Mean % per
The specific gamma ray constant for Technetium Tc 99m is 0.78 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for Technetium Tc 99m is 0.017 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.25 cm of Pb will decrease the external radiation exposure by a factor of about 1000.
|Coefficient of Attenuation|
To correct for physical decay of the radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.
* Calibration Time
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.
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.
No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females.
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 woman or can affect reproduction capacity. Technetium Tc 99m mertiatide should be given to a pregnant woman only if clearly needed.
Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.
Safety and effectiveness in pediatric patients under the age of 30 days have not been established.
The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.
The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi).
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.
The estimated absorbed radiation doses from an intravenous administration of technetium Tc 99m mertiatide are presented in Table 4.
* 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
|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|
|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|
|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|
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 (SnCl2•2H2O), 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl2•2H2O), 40 mg sodium tartrate dihydrate (Na2C4H2O6•2H2O), and 20 mg lactose monohydrate.
The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present.
Packages containing 5 reaction vials (NDC No. 0019-N096-BO) are available.
TechneScan MAG3 should be stored at controlled room temperature 20°C to 25°C (68-77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15°C to 30°C) and must be used within six hours of preparation.
Note: Read complete directions thoroughly before starting preparation procedure.
Note 1: Wear waterproof gloves during the entire preparation procedure and during subsequent 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.
* May be prepared by diluting 1 mL of 0.10N hydrochloric acid to 100 mL with Water for Injection, USP, or by other appropriate dilution of more concentrated hydrochloric acid. For example, 0.1 mL of 36% (~11.6N) hydrochloric acid diluted to a total volume of 1,150 mL.
** Prepared by mixing equal volumes of the 200 proof ethanol and 0.9% Sodium Chloride Injection, USP.
1. Percent technetium Tc 99m mertiatide =
|Activity of 2nd (ethanol/saline) fraction||x 100%|
|Total activity of all three fractions|
2. Percent hydrophilic impurities =
|Activity of 1st (0.001N HCl acid) fraction||x 100%|
|Total activity of all three fractions|
3. Percent non-elutable impurities =
|Activity remaining on Sep-Pak cartridge||x 100%|
|Total activity of all three fractions|
This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.
St. Louis, MO 63134 USA
|TechneScan MAG3 (Mertiatide)|
Data are from FDA and U.S. National Library of Medicine.