Trade Name: Technescan MAG3

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: 1 mg/1

Storage and handling

BETIATIDE

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Technescan MAG3u2122 is a kit for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,Nu2032,Nu2033,Su2032]oxotechnetate (2-)) which is formed is suitable for intravenous administration.
  • Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnClu20222HO) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnClu20222HO), 40 milligrams sodium tartrate dihydrate (NaCHOu20222HO), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas:
  • 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.
  • 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.
  • To correct for physical decay of the radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.
  • Following intravenous injection of technetium Tc 99m mertiatide, the appearance, concentration, and excretion of the tracer in the kidney can be monitored to assess renal function. Although technetium Tc 99m mertiatide is highly plasma protein bound following intravenous injection, the protein binding is reversible and the tracer is rapidly excreted by the kidneys via active tubular secretion and glomerular filtration. Following intravenous injection of technetium Tc 99m mertiatide in normal volunteers, 89% of the tracer was plasma protein bound. In healthy subjects with normal renal function (mean serum creatinine 1.2 mg/dL) technetium Tc 99m mertiatide was rapidly cleared from the blood. The plasma clearance was approximately 0.3 liters/minute and the amount of technetium Tc 99m mertiatide excreted in the urine in three hours was nearly 90% of the dose. In a study performed in three patients with renal impairment (serum creatinine greater than 6.3 mg/dL), there was decreased blood clearance and a decrease in the amount excreted in the urine over three hours. In these patients, 78% of the tracer was plasma protein bound after intravenous injection. The mean plasma clearance of technetium Tc 99m mertiatide was 0.03 liters/minute and 21.3% was excreted in three hours on average. In both healthy subjects and patients with renal impairment, the plasma concentration-time profile showed a biexponential decline.
  • Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See ) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
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  • The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.
  • The suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 u03bcCi/kg) to 5.2 MBq/kg (140 u03bcCi/kg) with a minimum dose of 37 MBq (1 mCi).
  • The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
  • Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.
  • The estimated absorbed radiation doses from an intravenous administration of technetium Tc 99m mertiatide are presented in Table 4.
  • Catalog Number 096.
  • Technescan MAG3 is supplied as a lyophilized powder packaged in vials. Each reaction vial contains 1 mg betiatide, 0.05 mg (minimum) stannous chloride dihydrate (SnClu20222HO), 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate (SnClu20222HO), 40 mg sodium tartrate dihydrate (NaCHOu20222HO), and 20 mg lactose monohydrate.
  • The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present.
  • Packages containing 5 reaction vials (NDC 69945-096-20) are available.
  • Technescan MAG3 should be stored at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) and protected from light until use. The reconstituted vial should be stored at room temperature (15u00b0 to 30u00b0C) and must be used within six hours of preparation.
  • Note:
  • No data
  • Technescan MAG3
  • Kit for the Preparation of Technetium Tc 99m Mertiatide Diagnostic
  • Vial contains:1 mg Betiatide0.05 mg (minimum) Stannous Chloride Dihydrate (SnCl u25cf 2HO)40 mg Sodium Tartrate Dihydrate0.2 mg (maximum) Total Tin as Stannous Chloride Dihydrate (SnCl u25cf 2HO)20 mg Lactose Monohydrate
  • Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment.u00a0The pH of the reconstituted drug is between 5.0 and 6.0.u00a0 The contents are sealed under argon.u00a0 Sterile, non-pyrogenic.u00a0For intravenous use after drug preparation.u00a0See package insert for directions for use.u00a0Store at 20u02da to 25u02daC (68u02da to77u02daF) and protect from light.u00a0Do not use sodium pertechnetate Tc 99m solutions containing an oxidizing agent.
  • Rx only
  • Manufactured by:Curium USu00a0LLCMaryland Heights, MO 63043
  • Made in USA
  • CURIUMn
  • A096V0u00a0n
  • R12/2018

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Technescan Tc 99m Mertiatide (Technescan MAG3) which is also known as Technescan MAG3 and Manufactured by Curium US LLC. It is available in strength of 1 mg/1.

Technescan Tc 99m Mertiatide (Technescan MAG3) 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.

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