TECHNESCAN HDP- technetium tc 99m oxidronate injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXIDRONATE DISODIUM (UNII: H852YK87WP) (OXIDRONIC ACID - UNII:71MR4V32TI)

Available from:

Curium US LLC

INN (International Name):

OXIDRONATE DISODIUM

Composition:

OXIDRONATE DISODIUM 3.15 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients. None known. All procedures should be conducted using waterproof gloves. Use shielded syringe during transport and administration of Tc 99m solutions. - Remove plastic disc from Technescan HDP vial and cleanse top by swabbing with alcohol. Note: If dose is for a single adult patient or for a pediatric patient, see unit dose preparation method below. - Place vial in lead vial shield. Add 3 to 6 mL of sodium pertechnetate Tc 99m solution and secure with a fitted lead cover. In choosing the amount of Tc 99m radioactivity to be used, the number of doses desired, the activity of each dose [recommended adult dose is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi)] and radioactive decay must be taken into account. The recommended maximum amount of Tc 99m radioactivity to be added to the vial is 11.1 gigabecquerels (300 mCi). Note: The contents of the vial are

Product summary:

Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2 •2H2 O), 0.297 mg, theoretical, stannous chloride (SnCl2 •2H2 O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl2 •2H2 O. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m. 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. Curium and the Curium logo are trademarks of a Curium company. ©2018 Curium US LLC. All Rights Reserved. Manufactured by: Curium US LLC 2703 Wagner Place Maryland Heights, MO 63043 Made in USA A091I0 R12/2018 CURIUM™

Authorization status:

New Drug Application

Summary of Product characteristics

TECHNESCAN HDP- TECHNETIUM TC 99M OXIDRONATE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
CURIUM US LLC
----------
TECHNESCAN™ HDP
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M OXIDRONATE
RX ONLY
_DIAGNOSTIC – FOR INTRAVENOUS USE_
DESCRIPTION
Technescan™ HDP is supplied as a lyophilized powder, packaged under
nitrogen in vials
for intravenous administration after reconstitution with ADDITIVE-FREE
sodium
pertechnetate Tc 99m. Each vial contains 3.15 mg oxidronate sodium and
0.258 mg,
minimum, stannous chloride (SnCl
•2H O), 0.297 mg, theoretical, stannous chloride
(SnCl
•2H O) with 0.343 mg, maximum, tin chloride [stannous and stannic]
dihydrate as
SnCl
•2H O as active ingredients. In addition, each vial contains 0.84 mg
gentisic acid as
a stabilizer and 30.0 mg sodium chloride. The pH is adjusted with
hydrochloric acid
and/or sodium hydroxide. The pH of the reconstituted drug is between
4.0 and 5.5. The
contents of the vial are sterile and non-pyrogenic.
The chemical structure of oxidronate sodium is:
This radiopharmaceutical diagnostic agent, when reconstituted with
ADDITIVE-FREE
sodium pertechnetate Tc 99m forms a complex of unknown structure.
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 _
Mean Percent/Energy
2
2
2
2
2
2
1
_1_
Radiation Disintegration (keV)
Gamma-2
89.07
140.5
1
EXTERNAL RADIATION
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) c