TECHNESCAN PYP- technetium tc 99m pyrophosphate injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ), STANNOUS CHLORIDE (UNII: 1BQV3749L5) (STANNOUS CATION - UNII:QI30938BMS)

Available from:

Curium US LLC

INN (International Name):

SODIUM PYROPHOSPHATE

Composition:

SODIUM PYROPHOSPHATE 11.9 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Technetium Tc 99m Pyrophosphate Injection is a skeletal imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the incidence of false negative images has been found to be 6%. False negative images can also occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. In a limited study involving 22 patients in whom the ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the incidence of false negative images was 23%. The incidence of false positive images has been found to be 7 to 9%. False positive images have been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions. Technescan PYP is a blood pool imaging agen

Product summary:

Catalog Number 094. Technescan PYP is supplied as a lyophilized powder packaged in vials. Each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl2 •2H2 O) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (SnCl2 •2H2 O), sealed under an atmosphere of nitrogen. Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. Kit containing 5 vials is available. The Technescan PYP Kit must be maintained in a refrigerator, 2° to 8°C (36° to 46°F) until use. The reconstituted vial should be stored at controlled room temperature, 20° to 25°C (68° to 77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

TECHNESCAN PYP- TECHNETIUM TC 99M PYROPHOSPHATE INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
CURIUM US LLC
----------
TECHNESCAN™ PYP™
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PYROPHOSPHATE INJECTION
RX ONLY
_DIAGNOSTIC–FOR INTRAVENOUS USE_
DESCRIPTION
Technescan™ PYP™ (Kit for the Preparation of Technetium Tc 99m
Pyrophosphate Injection) is a
sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for
intravenous administration after
reconstitution with sterile sodium pertechnetate Tc 99m injection or
sterile 0.9% sodium chloride
injection.
Each 10 milliliter reaction vial contains 11.9 milligrams sodium
pyrophosphate, 3.2 milligrams
(minimum) stannous chloride (SnCl
•2H O) and 4.4 milligrams (maximum) total tin expressed as
stannous chloride (SnCl
•2H O) in lyophilized form under an atmosphere of nitrogen. Prior to
lyophilization the pH is adjusted with hydrochloric acid. The pH of
the reconstituted drug is between
4.5 and 7.5. No bacteriostatic preservative is present.
The precise structures of the stannous-pyrophosphate and
technetium-stannous-pyrophosphate
complexes are not known at this time.
PHYSICAL CHARACTERISTICS
Technetium Tc 99m decays by isomeric transition with a physical
half-life of 6.02 hours.
The
principal photon that is useful for detection and imaging is listed in
Table 1.
TABLE 1. PRINCIPAL RADIATION EMISSION DATA
Radiation
Mean Percent/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 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.
TABLE 2. RADIATION ATTENUATION BY LEAD SHIELDING
Shield
Thickness (Pb) cm
Coefficient
of Attenuation
0.017
0.08
0.16
0.25
0.5
10
10
10
2
2
2
2
1
1
-1