Kit For The Preparation Of Technetium Tc 99m Medronate
Technetium Tc 99m Medronate
Cardinal Health 414, Llc
Human Prescription Drug
NDC 65857-505Kit For The Preparation Of Technetium Tc 99m Medronate also known as Technetium Tc 99m Medronate is a human prescription drug labeled by 'Cardinal Health 414, Llc'. National Drug Code (NDC) number for Kit For The Preparation Of Technetium Tc 99m Medronate is 65857-505. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Kit For The Preparation Of Technetium Tc 99m Medronate drug includes Technetium Tc-99m Medronate - 20 mg/1 . The currest status of Kit For The Preparation Of Technetium Tc 99m Medronate drug is Active.
Drug Information:
| Drug NDC: | 65857-505 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Kit For The Preparation Of Technetium Tc 99m Medronate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Technetium Tc 99m Medronate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health 414, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Powder, Lyophilized, For Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TECHNETIUM TC-99M MEDRONATE - 20 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA018107 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Cardinal Health 414, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000177914
N0000000205
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | X89XV46R07
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Radiopharmaceutical Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Radioactive Diagnostic Agent [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Radioactive Diagnostic Agent [EPC]
Radiopharmaceutical Activity [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 65857-505-10 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10) | 01 Dec, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Kit for the preparation of technetium tc 99m medronate technetium tc 99m medronate technetium tc-99m medronate technetium tc-99m medronate medronic acid ascorbic acid stannous fluoride sodium hydroxide hydrochloric acid
Indications and Usage:
Indications and usage technetium tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Warnings:
Warnings 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). preliminary reports indicate interference with brain scans using sodium pertechnetate tc 99m injection which have been preceded by a bone scan using an agent containing stannous ions. this interference may result in false-positive or false-negative brain scans. it is recommended, where feasible, that brain scans precede bone imaging procedures.
General Precautions:
General the contents of the kit before preparation are not radioactive. however, after the sodium pertechnetate tc 99m injection is added, adequate shielding of the final preparation must be maintained. contents of the reaction vial are intended only for use in the preparation of technetium tc 99m medronate and are not to be administered directly to the patient. technetium tc 99m medronate as well as other radioactive drugs, must be handled with care. once sodium pertechnetate tc 99m is added to the vial, appropriate safety measures should be used to minimize external radiation to clinical occupational personnel. care should also be taken to minimize radiation exposure to patients in a manner consistent with proper patient management. to minimize the radiation dose to the bladder, the patient should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours. technetium tc 99m medronate should be formul
Read more...ated within six (6) hours prior to clinical use. optimal imaging results are obtained one to four hours after administration. technetium tc 99m medronate injection should be discarded six hours after reconstitution. the solution should not be used if cloudy. the components of the kit are sterile and pyrogen-free. it is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation. the technetium tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. any oxidant present in the sodium pertechnetate tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. hence, sodium pertechnetate tc 99m containing oxidants should not be employed. radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
Dosage and Administration:
Dosage and administration after preparation with oxidant-free sodium pertechnetate tc 99m injection the suggested dose range of technetium tc 99m medronate injection in the average patient (70 kg) is 370 mbq to 740 mbq (10 mci to 20 mci) given intravenously. imaging post injection is optimal at 1 to 4 hours. 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 whenever solution and container permit. shielding should be utilized when preparing the technetium tc 99m medronate injection. 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 patient (70 kg) from an intravenous injection of a maximum dose of 740 mbq (20 mci) of technetium tc 99m medronate are shown in table 4 . table 4 absorbed radi
Read more...ation dose 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-hr. void 26.0 2.60 4.8-hr. void 62.0 6.20 ovaries 2-hr. void 2.4 0.24 4.8-hr. void 3.4 0.34 testes 2-hr. void 1.6 0.16 4.8-hr. void 2.2 0.22 method of calculation: âsâ absorbed dose per unit cumulated activity for selected radionuclides and organs, mird pamphlet no. 11, 1975
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions several adverse reactions due to technetium tc 99m medronate 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.
Use in Pregnancy:
Pregnancy animal reproduction studies have not been conducted with technetium tc 99m medronate. it is also not known whether technetium tc 99m medronate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. technetium tc 99m medronate should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in children have not been established.
Description:
Description each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, snf 2 and 0.38 mg total tin, maximum (as stannous fluoride, snf 2 ). the ph is adjusted with sodium hydroxide or hydrochloric acid to 6.5 (6.3 to 6.7) 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 structure of medronic acid is given below: the precise structure of technetium tc 99m medronate is unknown at this time. when sterile, pyrogen-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. structure of medronic acid
Clinical Pharmacology:
Clinical pharmacology during the initial 24 hours following intravenous injection of technetium tc 99m medronate, about 50 percent of the dose is retained in the skeleton, and about 50 percent is excreted in the urine. a minimum amount of uptake has been observed in soft-tissue organs, most notably the kidneys. clearance of radioactivity from the blood is quite rapid, with about 10 percent of the injected dose remaining at one hour, and less than 5 and 2 percent at two and four hours, respectively. the rapid blood clearance (t ½: 38 to 75 minutes) provides bone to non-osseous tissue ratios favoring early imaging. following intravenous administration of technetium tc 99m medronate, skeletal uptake occurs as a function of blood flow to bone and bone efficiency in extracting the complex. bone mineral crystals are generally considered to be hydroxyapatite, and the complex appears to have an affinity for the hydroxyapatite crystals in bone. deposition of radioactivity in bone is rapid an
Read more...d appears to be related to osteogenic activity as well as the aforementioned skeletal blood perfusion. skeletal uptake is bilaterally uniform, with larger concentrations in the axial structure and in the long bones. increased accumulation of radioactivity may be seen, generally, in any bone disease state in which there is increased osteogenesis or a localized increase in osseous blood perfusion; consequently, bone imaging agents generally are not effective in detecting chronic bone diseases.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no long-term animal studies have been performed to evaluate carcinogenic potential or whether technetium tc 99m medronate affects fertility in males or females.
How Supplied:
How supplied kit for the preparation of technetium tc 99m medronate is supplied as kits of 10 reaction vials (ndc 65857-505-10). each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, snf 2 and 0.38 mg total tin, maximum (as stannous fluoride, snf 2 ). the ph is adjusted with sodium hydroxide 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 10 sterile reaction vials 20 pressure-sensitive labels for technetium tc 99m medronate 1 package insert storage store the product as supplied at 20° to 25°c (68° to 77°f). after reconstitution store refrigerated at 2° to 8°c (36° to 46°f) ( see dosage and administration ). do not use and discard radiolabeled technetium
Read more...tc 99m medronate 6 hours after reconstitution.
Package Label Principal Display Panel:
Principal display panel - carton label carton label diagnostic ndc 65857-505-10 kit for the preparation of technetium tc 99m medronate rx only ⢠store the product at 20° to 25°c (68° to 77°f) ⢠for intravenous use after radiolabeling with sodium pertechnetate tc 99m. after reconstitution, store refrigerated 2° to 8°c (36° to 46°f) ⢠use within 6 hours after reconstitution. contents: 10 sterile multi-dose reaction vials 20 radioactivity labels prescribing information cardinal health⢠nonradioactive kit for the preparation of technetium tc 99m medronate for preparation of technetium tc 99m medronate for bone imaging each reaction vial contains a sterile, nonpyrogenic nonradioactive lyophilized mixture of 20 mg medronic acid , 1 mg ascorbic acid, and 0.13 mg (minimum) stannous fluoride snf 2 and 0.38 mg total tin, maximum (as stannous fluoride, snf 2 ); ph adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. distributed by cardinal health 414, llc dublin, oh 43017 contains no preservative. vial contents are sealed under nitrogen at time of manufacture. recommended dose: see prescribing information 876659-h01 lot 12345 yyy-mm-dd principal display panel - carton label