Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
OXIDRONATE DISODIUM (UNII: H852YK87WP) (OXIDRONIC ACID - UNII:71MR4V32TI)
Curium US LLC
OXIDRONATE DISODIUM
OXIDRONATE DISODIUM 3.15 mg
INTRAVENOUS
PRESCRIPTION DRUG
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
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™
New Drug Application
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 Prečítajte si celý dokument