Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 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 2 ) and 0.38 mg maximum total tin, as stannous fluoride, SnF 2 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. Kit Contents Included in each five (5) vial kit is one (1) package insert and ten (10) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and sixty (60) radiation labels. Storage Store the product as supplied at 20-25°C (68-77°F) [See USP]. After reconstitution store at 20-25°C (68-77°F) [See USP] (see DOSAGE AND ADMINISTRATION).; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CONTAINER NDC 045567-0040-1 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 20-25°C (68-77°F), 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 5 Vial Container Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CARTON NDC 045567-0040-1 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 20-25°C (68-77°F), see USP IMPORTANT: Read the enclosed package insert for full information on preparation, use and directions. Store reconstituted vials at 20-25°C (68-77°F), 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 5 Vial Carton Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CONTAINER NDC 045567-0040-2 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 20-25°C (68-77°F), 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 30 Vial Container Lable; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CARTON NDC 045567-0040-2 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, 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 20-25°C (68-77°F), see USP IMPORTANT: Read the enclosed package insert for full information on preparation, use and directions. Store reconstituted vials at 20-25°C (68-77°F), 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 30 Vial Carton Label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – RADIATION SHIELD 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 – 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 20-25°C (68-77°F), see USP, after labeling with Techneitum Tc99m. Use within 6 hours after reconstitution. The recommended adult dose is 370 – 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 Shield Label
- HOW SUPPLIED: 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 2 ) and 0.38 mg maximum total tin, as stannous fluoride, SnF 2 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. Kit Contents Included in each five (5) vial kit is one (1) package insert and ten (10) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and sixty (60) radiation labels. Storage Store the product as supplied at 20-25°C (68-77°F) [See USP]. After reconstitution store at 20-25°C (68-77°F) [See USP] (see DOSAGE AND ADMINISTRATION).
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CONTAINER NDC 045567-0040-1 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 20-25°C (68-77°F), 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 5 Vial Container Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CARTON NDC 045567-0040-1 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 20-25°C (68-77°F), see USP IMPORTANT: Read the enclosed package insert for full information on preparation, use and directions. Store reconstituted vials at 20-25°C (68-77°F), 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 5 Vial Carton Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CONTAINER NDC 045567-0040-2 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 20-25°C (68-77°F), 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 30 Vial Container Lable
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CARTON NDC 045567-0040-2 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, 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 20-25°C (68-77°F), see USP IMPORTANT: Read the enclosed package insert for full information on preparation, use and directions. Store reconstituted vials at 20-25°C (68-77°F), 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 30 Vial Carton Label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – RADIATION SHIELD 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 – 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 20-25°C (68-77°F), see USP, after labeling with Techneitum Tc99m. Use within 6 hours after reconstitution. The recommended adult dose is 370 – 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 Shield Label
Overview
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: Medronic acid: 20 mg Ascorbic acid: 1 mg Stannous fluoride, SnF 2 : 0.13 mg (minimum) Total tin (maximum, as stannous fluoride, SnF 2 ): 0.38 mg 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. Structural Formula PHYSICAL CHARACTERISTICS: Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours 1 . The principal photon that is useful for detection and imaging studies is listed in Table 1. TABLE 1 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 1 Kocher, DC: Radioactive Decay Data Tables, DOE/TIC-11026, 108, 1981 . EXTERNAL RADIATION: The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1 cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of the various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. TABLE 2 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. TABLE 3 Physical Decay Chart: Tc 99m, Half-Life 6.02 Hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 * Calibration Time
Indications & Usage
: Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Dosage & Administration
DOSAGES AND ADMINISTRATION: 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: 370-740 megabecquerels: (10-20 millicuries) given intravenously. Imaging is optimal at 1 to 4 hours post Injection. 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. Radiation Dosimetry 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. TABLE 4 Estimated Absorbed Radiation Dose 2 Technetium Tc 99m Medronate Organ (MGy/740 MBq) (Rads / 20 mCi) Total Body 1.3 0.13 Bone Total 7.0 0.70 Red Marrow 5.6 0.56 Kidneys 8.0 0.80 Liver 0.6 0.06 Bladder Wall 2 hour void 26 2.60 4.8 hour void 62 6.20 Ovaries 2 hour void 2.4 0.24 4.8 hour void 3.4 0.34 Testes 2 hour void 1.6 0.16 4.8 hour void 2.2 0.22 2 Method of calculation: "S" Absorbed Dose Per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No 11 (1975)
Warnings & Precautions
WARNINGS: 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. The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)
Contraindications
: None known.
Adverse Reactions
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.
Storage & Handling
Storage Store the product as supplied at 20-25°C (68-77°F) [See USP]. After reconstitution store at 20-25°C (68-77°F) [See USP] (see DOSAGE AND ADMINISTRATION).
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