ULTRA-TECHNEKOW DTE- technetium tc-99m injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

TECHNETIUM TC-99M SODIUM PERTECHNETATE (UNII: A0730CX801) (TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1)

Доступна с:

Curium US LLC

ИНН (Международная Имя):

TECHNETIUM TC-99M SODIUM PERTECHNETATE

состав:

MOLYBDENUM MO-99 1 Ci

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

The Ultra-Technekow DTE generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:         Thyroid Imaging          Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux         Nasolacrimal Drainage System Imaging (dacryoscintigraphy) Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:         Thyroid Imaging         Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux None. See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risk under WARNINGS .

Обзор продуктов:

The Ultra-Technekow™ DTE (Technetium Tc 99m) Generators contain the following amount of molybdenum Mo-99 at the date and time of calibration stated on the label. Each generator is supplied with the following components for the elution of the generator:       7 - Evacuated Collecting Vials, 10 mL, Sterile, Non-Pyrogenic       or        5 - Evacuated Collecting Vials, 20 mL, Sterile, Non-Pyrogenic        7 - 70% (v/v) Isopropyl Alcohol Wipes       7 - Pressure-sensitive "Caution - Radioactive Material" collecting vial labels       7 - Pressure-sensitive radioassay data labels for lead elution shield        1 - Generator Eluant Vial, 135 mL, Sterile, Non-Pyrogenic       or       2 - Generator Eluant Vials, 135 mL, Sterile, Non-Pyrogenic        1 - Technestat™ Vial, 5 mL, containing 0.5 mL of 1.5 mg/mL methylparaben and 0.2 mg/mL propylparaben, Sterile, Non-pyrogenic        1 - Package Insert The sterile, non-pyrogenic solution used to elute the generator column contains 0.9% sodium chloride. The eluant does not contain an antimicrobial agent. EVACUATED COLLECTING VIALS. Collecting vials are available on request in 10 and 20 milliliter sizes.

Статус Авторизация:

New Drug Application

Характеристики продукта

ULTRA-TECHNEKOW DTE- TECHNETIUM TC-99M INJECTION, SOLUTION
CURIUM US LLC
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ULTRA-TECHNEKOW DTE
(TECHNETIUM TC 99M GENERATOR)
RX ONLY
_FOR THE PRODUCTION OF_
_SODIUM PERTECHNETATE TC 99M INJECTION_
DESCRIPTION
The Ultra-Technekow DTE Generator is prepared with fission-produced
molybdenum Mo-99
adsorbed onto alumina column shielded by lead, tungsten, or depleted
uranium. This generator provides
a closed system for the production of sterile metastable technetium
Tc-99m, which is produced by the
decay of molybdenum Mo-99. Sterile, non-pyrogenic isotonic solutions
of Sodium Pertechnetate Tc
99m can be obtained conveniently by periodic aseptic elution of the
generator. These solutions should
be clear, colorless, and free from any particulate matter.
The carrier-free solution may be used as is, or diluted to the proper
concentration. Over the life of the
generator, an elution will contain an amount of technetium Tc-99m in
direct proportion to the quantity of
Mo-99 decay since the previous elution of the generator. The quantity
of Tc-99m in the eluate is
determined by quantity of Mo-99 on the column and the elapsed time
between elutions.
Each eluate of the generator should not contain more than the USP
limit of
0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium
Tc-99m
(0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose at
the time of administration and
an aluminum ion concentration of not more than 10 micrograms per
milliliter of the generator eluate,
both of which must be determined by the user before administration.
Since the eluate does not contain an antimicrobial agent, it should
not be used after
12 hours from the time of generator elution.
PHYSICAL CHARACTERISTICS
Technetium Tc-99m decays by isomeric transition with a physical
half-life of 6 hours. The principal
photon that is useful for detection and imaging studies is listed in
Table 1.
_Table 1. Principal Radiation _
_Emission Data_
Radiation
Mean Percent
Per
Disintegration
Energy
(keV)
Gamma-2
89.07
140.5
EXTERNAL RADIATI