Trade Name: Technescan HDP

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Curium US LLC

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 3.15 mg/1

Storage and handling

OXIDRONATE DISODIUM

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Technetium Tc 99m Oxidronate (Technescan HDP) which is also known as Technescan HDP and Manufactured by Curium US LLC. It is available in strength of 3.15 mg/1.

Technetium Tc 99m Oxidronate (Technescan HDP) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Technescanu2122 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 (SnClu20222HO), 0.297 mg, theoretical, stannous chloride (SnClu20222HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnClu20222HO 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.
  • 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 Datau00a0
  • 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
  • To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.
  • Table 3. Physical Decay Chart: Technetium Tc 99m Half-Life 6.02 Hours
  • * Calibration time
  • During the 24 hours following injection, Technetium Tc 99m-labeled Technescan HDP is rapidly cleared from blood and other non-osseous tissues and accumulates in the skeleton and urine in humans. Blood levels are about 10% of the injected dose at one hour post-injection and continue to fall to about 6%, 4% and 3% at 2, 3 and 4 hours, respectively. When measured at 24 hours following its administration, skeletal retention is approximately 50% of the injected dose. Technescan HDP exhibits its greatest affinity for areas of altered osteogenesis and actively metabolizing bone.
  • Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.
  • None known.
  • Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions.u00a0u00a0u00a0 Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
  • This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (i.e., alkalosis).
  • No data
  • Hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting and injection site reactions, have been infrequently reported with Technetium Tc 99m Oxidronate use.
  • The recommended adult dose of Technetium Tc 99m-labeled Technescan HDP is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi). The recommended pediatric dose is 7.4 MBq (0.20 mCi)/kg with a range of 7.4 to 13 MBq (0.20 to 0.35 mCi)/kg. The recommended minimum total pediatric dose is 37 MBq (1.0 mCi). The maximum total dose injected into a pediatric or adult patient is 740 MBq (20.0 mCi). The maximum dose of oxidronate sodium should not exceed 2 mg.
  • Unit dose preparation instructions should be followed for pediatric patients. The radioactivity of each dose should be measured by a suitable radiation calibration system just prior to administration. The dose should be given intravenously by slow injection. For optimal results imaging should be performed 1 to 4 hours post-injection.
  • The estimated absorbed radiation doses from an intravenous injection of Technetium Tc 99m-labeled Technescan HDP are shown in Table 4.
  • Table 4. Estimated Absorbed Radiation Dose*
  • *u00a0 Based on data in MIRD Dose Estimate Report No. 14. Bladder initially voided at 2.0 hours and then every 4.8 hours thereafter.
  • ** See Dosage and Administration section.
  • All procedures should be conducted using waterproof gloves. Use shielded syringe during transport and administration of Tc 99m solutions.
  • To minimize volume injected and to ensure optimum solution concentration, reconstitute the vial contents in 3 to 6 mL of sterile, non-pyrogenic normal saline containing no preservatives. Shake the vial gently for approximately 30 seconds to assure complete dissolution, withdraw and discard all but approximately 1 mL of the solution. Add appropriate amount of sodium pertechnetate Tc 99m for a single adult dose or for one or more pediatric doses and shake gently. Proceed with steps 4 and 5. No more than 1480 MBq (40 mCi) should be added to the vial when preparing multiple pediatric doses. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  • 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 (SnClu20222HO), 0.297 mg, theoretical, stannous chloride (SnClu20222HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnClu20222HO. 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 20u00ba to 25u00baC (68u00ba to 77u00baF) 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.u00a92018 Curium US LLC. All Rights Reserved.
  • Manufactured by: Curium USu00a0LLC2703 Wagner PlaceMaryland Heights, MO 63043
  • Made in USA
  • A091I0
  • R12/2018
  • CURIUMu2122
  • Technescanu2122 HDPn n- Kit for the Preparation of Technetium Tc 99m OxidronateSterile, Non-Pyrogenic, for IV Injection with Sodium Pertechnetate Tc 99m
  • Rx only
  • Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl u25cf 2HO), 0.297 mg, theoretical, stannous chloride (SnCl u25cf 2HO), with 0.343 mg, maximum tin chloride [stannous and stannic] dihydrate as SnCl u25cf 2HO.u00a0 In addition, each vial contains 0.84 mg gentisic acid (stabilizer) and 30.0 mg sodium chloride.u00a0 The pH is adjusted with HCI and/or NaOH.u00a0 Contents are lyophilized and sealed under nitrogen. Use within 8 hours of preparation.
  • Manufactured by:Curium USu00a0LLCMaryland Heights, MO 63043
  • Made in USA
  • CURIUMu2122
  • A091V0
  • R12/2018

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