KIT FOR THE PREPARATION OF TECHNETIUM TC99M DISOFENIN- hepatolite injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

TECHNETIUM TC-99M DISOFENIN (UNII: QTJ2VIW97T) (TECHNETIUM TC-99M DISOFENIN - UNII:QTJ2VIW97T)

Доступна с:

Pharmalucence, Inc.

ИНН (Международная Имя):

TECHNETIUM TC-99M DISOFENIN

состав:

DISOFENIN 20 mg in 10 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Technetium Tc99m Disofenin is indicated as a hepatobiliary imaging agent. Hepatolite is indicated in the diagnosis of acute cholecystitis as well as to rule out the occurrence of acute cholecystitis in suspected patients with right upper quadrant pain, fever, jaundice, right upper quadrant tenderness and mass or rebound tenderness, but not limited to these signs and symptoms. In otherwise healthy individuals, non-visualization of the gallbladder 4 hours after administration of Hepatolite following a 2-6 hour fast and in the presence of activity in the small intestine is indicative of a diagnosis of acute cholecystitis. Under the same conditions in an otherwise healthy person, visualization of the gallbladder during a 1 hour scintigraphy is effective in excluding a diagnosis of acute cholecystitis. If the gallbladder is not visualized by 1 hour, scanning must continue for four hours or until the gallbladder is visualized. When the gall bladder fails to appear within the first 60 minutes of imaging after th

Обзор продуктов:

HEPATOLITE® Kit for the Preparation of Technetium Tc99m Disofenin for Injection is supplied as a set of five or thirty vials, sterile and non-pyrogenic. Prior to lyophilization the pH is adjusted to between 4-5 with hydrochloric acid and/or sodium hydroxide solution. The contents of the vial are lyophilized and stored under nitrogen. Store at controlled room temperature (20 - 25°C) before and after reconstitution. Protect from light. The lyophilized drug product is light sensitive. Technetium Tc99m Disofenin contains no preservatives. Included in each five (5) vial kit is one (1) package insert and twelve (12) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and seventy-two (72) radiation labels. This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State. Manufactured by: Pharmalucence, Inc. Billerica, MA 01821 PL-000027 Rev 1.0 Jun 2018 For ordering Tel. Toll Free: 800-221-7554 (For International, call: 781-275-7120)

Статус Авторизация:

New Drug Application

Характеристики продукта

KIT FOR THE PREPARATION OF TECHNETIUM TC99M DISOFENIN- HEPATOLITE
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
PHARMALUCENCE, INC.
----------
HEPATOLITE KIT FOR THE PREPARATION OF TECHNETIUM TC99M DISOFENIN FOR
INJECTION FOR
DIAGNOSTIC USE
DESCRIPTION
Each vial contains a sterile, non-pyrogenic, lyophilized mixture of
Disofenin - 20 mg
Stannous Chloride, minimum (SnCL •2H 0) - 0.24mg
Total Tin, maximum (SnCL •2H 0) - 0.6 mg
Prior to lyophilization the pH is adjusted to between 4-5 with HCL
and/or NaOH. The contents of the
vial are lyophilized and stored under nitrogen.
The drug is administered by intravenous injection for diagnostic use
after reconstitution with sterile,
non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection.
The structure of disofenin is shown below:
The precise structure of stannous technetium-disofenin complex is
unknown at this time.
PHYSICAL CHARACTERISTICS
Technetium Tc99m decays by isomeric transition with a physical
half-life of 6.02 hours.
Photons that
are useful for detection and imaging studies are listed in Table 1.
TABLE 1. PRINCIPAL RADIATION
EMISSION DATA
Radiation
Mean % per Disintegration
Mean Energy (keV)
Gamma-2
89.07
140.5
Kocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 108
(1981).
EXTERNAL RADIATION
The specific gamma ray constant for Tc99m is 5.4
microcoulombs/kg-MBq-hr (0.78R/mCi-hr) at 1cm.
The first half value layer is 0.017cm of Pb. A range of values for the
relative attenuation of the
radiation emitted by this radionuclide that results from interposition
of various thicknesses of lead (Pb)
is shown in Table 2. To facilitate control of the radiation exposure
from MBq (mCi) amounts of this
radionuclide, the use of a 0.25cm thickness of lead (Pb) will
attenuate the radiation emitted by a factor
®
2
2
2
2
1
1
of 1,000.
TABLE 2. RADIATION ATTENUATION BY LEAD SHIELDING
Shield Thickness (Pb) cm
Coefficient of Attenuation
0.017
0.5
0.08
10
0.16
10
0.25
10
0.33
10
To correct for physical decay of this radionuclide, the fractions that
remain at sele