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Tc 99m Medronate (Kit For The Preparation Of Technetium Tc 99m Medronate)

Trade Name : Kit for the Preparation of Technetium Tc 99M Medronate

Pharmalucence, Inc.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 20 mg/10mL

TECHNETIUM TC-99M MEDRONATE Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tc 99m Medronate (Kit For The Preparation Of Technetium Tc 99m Medronate) which is also known as Kit for the Preparation of Technetium Tc 99M Medronate and Manufactured by Pharmalucence, Inc.. It is available in strength of 20 mg/10mL per ml. Read more

Tc 99m Medronate (Kit For The Preparation Of Technetium Tc 99m Medronate) 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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection.
  • Each 10mL multidose vial contains:
  • The pH is adjusted to 6.5 (6.3 to 6.7) with sodium hydroxide and/or hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present in the vial. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The structural formula is:
  • When a solution of sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection is added to the vial, the diagnostic agent, Technetium Tc 99m Medronate is formed for administration by intravenous injection. The pH of the reconstituted product is 5.4 to 6.8. The precise structure of Technetium Tc 99m Medronate Injection is not known at this time.
  • During the initial 24 hours following intravenous injection of Technetium Tc 99m Medronate, about 50% of each dose is retained in the skeleton, and about 50% is excreted in the urine. Upon intravenous injection, Technetium Tc 99m Medronate exhibits a specific affinity for areas of altered osteogenesis. In humans, blood levels fall to 4 to 10% of the injected dose by two hours post-injection and to 3 to 5% by three hours.
  • Uptake of Technetium Tc 99m Medronate Injection in bone appears to be related to osteogenic activity and to skeletal blood perfusion. The deposition in the skeleton is bilaterally symmetrical, with increased accumulation in the axial structure as compared to the appendicular skeleton. There is increased activity in the distal aspect on long bones as compared to the diaphyses.
  • Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.
  • None known.
  • This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or may be predisposed to hypocalcemia (i.e., alkalosis).
  • Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc 99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternatively, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.
  • No data
  • Several adverse reactions due to Technetium Tc 99m Medronate Injection have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of Technetium Tc 99m Medronate.
  • Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection.
  • After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is:
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  • The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
  • The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate Injection are shown in Table 4.
  • Kit for the Preparation of Technetium Tc 99m Medronate Injection is supplied in kits of five (5) or thirty (30) sterile, non-pyrogenic vials. Each 10 mL multidose vial contains 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg minimum stannous fluoride (SnF) and 0.38 mg maximum total tin, as stannous fluoride, SnF in lyophilized form. The pH is adjusted with sodium hydroxide and/or hydrochloric acid prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8.
  • The lyophilized powder in the reaction vial is sterile and non-pyrogenic and does not contain a preservative. Shielded syringes and aseptic procedures normally employed in making additions and withdrawals from sterile, non-pyrogenic containers should be used during addition of pertechnetate solution to the reaction vial and the withdrawal of doses for patient administration.
  • If sodium pertechnetate Tc 99m must be diluted prior to injection into the reaction vial, only Sodium Chloride Injection USP 0.9% (without preservatives) should be used.
  • Technetium Tc 99m Medronate Injection is prepared from Kit for the Preparation of Technetium Tc 99m Medronate for Injection by the following aseptic procedure:
  • NDC# 045567-0040-1 (5 vial pack)
  • NDC# 045567-0040-2 (30 vial pack)
  • This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.
  • PL-000007
  • Rev 1.1
  • Mar 2020
  • Manufactured By:
  • Sun Pharmaceutical Industries, Inc.
  • Billerica, MA 01821
  • 1-800-221-7554
  • (For International, call 781-275-7120)
  • NDC
  • Sun Pharmaceutical Industries, Inc.
  • Kit for the Preparation of Technetium Tc99m Medronate for Injection
  • Rx Only
  • STERILE
  • DIAGNOSTIC
  • MULTIDOSE
  • NON-PYROGENIC
  • Each 10mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid; 0.13mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3 - 6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. The recommended adult dose is 370 - 740 megabecquerels (10-20 millicuries). Refer to the package insert for directions for use.
  • CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER LABELING WITH OXIDANT-FREE TECHNETIUM Tc99m. After labeling with Technetium Tc99m, store at 20-25u00b0C (68-77u00b0F), see USP. Use within 6 hours after reconstitution.
  • 10 mL
  • Manufactured By:
  • Sun Pharmaceutical Industries, Inc.
  • Billerica, MA 01821
  • PL-000008
  • Rev 0.2
  • Mar 2020
  • NDC
  • Sun Pharmaceutical Industries, Inc.
  • Kit for the Preparation of Technetium Tc99m Medronate for Injection
  • Rx Only
  • STERILE
  • DIAGNOSTIC
  • MULTIDOSE
  • NON-PYROGENIC
  • CONTENTS:
  • 1 Package insert, 10 radiation labels and 5 reaction vials. Each 10 mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3-6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy.
  • Store as packaged at 20-25u00b0C (68-77u00b0F), see USP
  • IMPORTANT:
  • Read the enclosed package insert for full information on preparation, use and directions.
  • Store reconstituted vials at 20-25u00b0C (68-77u00b0F), see USP. Use within 6 hours after reconstitution.
  • The recommended adult dose is 370-740 megabecquerels (10-20 millicuries).
  • Manufactured By:
  • Sun Pharmaceutical Industries, Inc.
  • Billerica, MA 01821
  • PL-000010
  • Rev 0.3
  • Mar 2020
  • NDC
  • u00a0Sun Pharmaceutical Industries, Inc.
  • Kit for the Preparation of Technetium Tc99m Medronate for Injection
  • Rx Only
  • STERILE
  • DIAGNOSTIC
  • MULTIDOSE
  • NON-PYROGENIC
  • Each 10mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid; 0.13mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3 - 6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. The recommended adult dose is 370 - 740 megabecquerels (10-20 millicuries). Refer to the package insert for directions for use.
  • CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER LABELING WITH OXIDANT-FREE TECHNETIUM Tc99m. After labeling with Technetium Tc99m, store at 20-25u00b0C (68-77u00b0F), see USP. Use within 6 hours after reconstitution.
  • 10 mL
  • Manufactured By:
  • Sun Pharmaceutical Industries, Inc.
  • Billerica, MA 01821
  • PL-000008
  • Rev 0.2
  • Mar 2020
  • NDC
  • u00a0Sun Pharmaceutical Industries, Inc.
  • Kit for the Preparation of Technetium Tc99m Medronate for Injection
  • Rx Only
  • STERILE
  • DIAGNOSTIC
  • MULTIDOSE
  • NON-PYROGENIC
  • CONTENTS:
  • 1 Package insert, 60 radiation labels and 30 reaction vials. Each 10 mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3-6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy.
  • Store as packaged at 20-25u00b0C (68-77u00b0F), see USP
  • IMPORTANT:
  • Read the enclosed package insert for full information on preparation, use and directions.
  • Store reconstituted vials at 20-25u00b0C (68-77u00b0F), see USP. Use within 6 hours after reconstitution.
  • The recommended adult dose is 370-740 megabecquerels (10-20 millicuries).
  • Manufactured By:
  • Sun Pharmaceutical Industries, Inc.
  • Billerica, MA 01821
  • PL-000011
  • Rev 0.3
  • Mar 2020
  • CAUTION RADIOACTIVE MATERIAL
  • STERILE, NON-PYROGENIC, DIAGNOSTIC, KIT FOR THE PREPARATION OF TECHNETIUM Tc 99m MEDRONATE INJECTION DIAGNOSTIC FOR INTRAVENOUS USE
  • Total MBq (mCi)____Volume_____
  • Assay_____MBq/mL(mCi/mL) as of_____
  • Each 10 mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid; 0.13 mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3 u2013 6.7) with NaOH and/or HCl prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc99m. Do not use if solution is cloudy. Store the reconstituted vial at 20-25u00b0C (68-77u00b0F), see USP, after labeling with Techneitum Tc99m. Use within 6 hours after reconstitution. The recommended adult dose is 370 u2013 740 megabecquerels (10-20 millicuries). Refer to the package insert for directions for use.
  • (SEE ENCLSOED PACKAGE INSERT)
  • Rx ONLY
  • Manufactured by:
  • Sun Pharmaceutical Industries, Inc.
  • Billerica, MA 01821
  • PL-000009
  • Rev 0.2
  • Mar 2020

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