Inserto Mag3

Kit for the Preparation of Technetium
Tc 99m Mertiatide
Rx Only.

Fraction
Remaining

Hours

1.000

7

1

0.891

8

0.398

2

0.794

9

0.355

3

0.708

10

0.316

4

0.631

11

0.282

5

0.562

12

0.251

6

0.501

Hours
0*

Diagnostic-For Intravenous Use

DESCRIPTION
TechneScan MAG3® is a kit for the preparation of
technetium Tc99m mer tiatide, a diagnostic radiophamaceutical. 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
per technetate Tc 99m injection, the technetium Tc
99m mer tiatide (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 tolyophilization, 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 preser vative is present. The contents are
sealed under argon. Betiatide is light sensitive and
must be protected from light. Betiatide and technetium Tc 99m mer tiatide have the following structural formulas:

Fraction
Remaining
0.447*Calibration Time
CLINICAL PHARMACOLOGY
Following intravenous injection of technetium Tc
99m mer tiatide, the appearance, concentration,
and excretion of the tracer in the kidney can be
monitored to assess renal function. Although technetium Tc 99m mer tiatide is highly plasma protein
bound following intravenous injection, the protein
binding is reversible and the tracer is rapidly
excretedby the kidneys via active tubular secretion and glomerular filtration. Following intravenous injection of technetium Tc 99m mer tiatide
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 mer tiatide was rapidly cleared
from the blood. The plasma clearance was approximately 0.3liters/minute and the amount of technetium Tc 99m mer tiatide 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 boundafter intravenous injection. The
mean plasma clearance of technetium Tc 99m
mer tiatide 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
Technetium Tc 99m mer tiatide is a renal imaging
agent for use in thediagnosis 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 cur ves for whole kidney and renal cor tex.

PHYSICAL CHARACTERISTICS
Technetium Tc 99m decays by isomeric transition
with a physicalhalf-life of 6.02 hours.1 The principal photon that is useful for detection and imaging
is listed in Table 1.
Table 1. Principal Radiation Emission Data1
Radiation
M

Mean % per
Disintegration

Energy
(keV)

Gamma-2

89.07

140.5

The specific gamma ray constant for Technetium
Tc 99m is 0.78 R/mCi-hr at 1 cm. The first halfvalue thickness of lead (Pb) for Technetium Tc
99m is...