Technescan Hdp
Technetium Tc 99m Oxidronate
Curium Us Llc
Human Prescription Drug
NDC 69945-091Technescan Hdp also known as Technetium Tc 99m Oxidronate is a human prescription drug labeled by 'Curium Us Llc'. National Drug Code (NDC) number for Technescan Hdp is 69945-091. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Technescan Hdp drug includes Oxidronate Disodium - 3.15 mg/1 . The currest status of Technescan Hdp drug is Active.
Drug Information:
| Drug NDC: | 69945-091 |
| 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: | Technescan Hdp |
| 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 Oxidronate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Curium Us 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: | OXIDRONATE DISODIUM - 3.15 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: | 13 Oct, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jan, 2026 |
| 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: | NDA018321 |
| 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: | Curium US 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. |
| UNII: | H852YK87WP
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69945-091-20 | 5 VIAL in 1 CELLO PACK (69945-091-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 13 Oct, 2015 | N/A | No |
| 69945-091-40 | 30 VIAL in 1 CARTON (69945-091-40) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 13 Oct, 2015 | 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:
Technescan hdp technetium tc 99m oxidronate oxidronate disodium oxidronic acid stannous chloride gentisic acid sodium chloride
Indications and Usage:
Indications and usage technescan hdp tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.
Warnings:
Warnings technetium tc 99m oxidronate may cause life-threatening hypersensitivity reactions. 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).
General Precautions:
General the components of the kit are sterile and non-pyrogenic. it is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. sodium pertechnetate tc 99m solutions which contain an oxidizing agent or saline solutions containing preservatives are not suitable for use in the preparation of technescan hdp tc 99m. contents of the vial are intended only for use in the preparation of technetium tc 99m oxidronate and are not to be administered directly to the patient. technetium tc 99m oxidronate should be formulated within eight (8) hours prior to clinical use. optimal imaging results are obtained one to four hours after administration. technetium tc 99m oxidronate as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. radiop
Read more...harmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. to minimize radiation dose to the bladder, the patients 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.
Dosage and Administration:
Dosage and administration general instructions 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.
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions 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.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with technetium tc 99m oxidronate. it is also not known whether technetium tc 99m oxidronate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. technetium tc 99m oxidronate should be given to a pregnant woman only if clearly needed. ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Overdosage:
Overdose in the event of the administration of an overdose with technescan hdp, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.
Description:
Description technescan⢠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 (sncl 2 â¢2h 2 o), 0.297 mg, theoretical, stannous chloride (sncl 2 â¢2h 2 o) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as sncl 2 â¢2h 2 o 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. chemical structure
Clinical Pharmacology:
Clinical pharmacology 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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether technetium tc 99m oxidronate affects fertility in males and females.
How Supplied:
How supplied 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 (sncl 2 â¢2h 2 o), 0.297 mg, theoretical, stannous chloride (sncl 2 â¢2h 2 o) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as sncl 2 â¢2h 2 o. 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 20º to 25ºc (68º to 77ºf) 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.
Read more...©2018 curium us llc. all rights reserved. manufactured by: curium us llc 2703 wagner place maryland heights, mo 63043 made in usa a091i0 r12/2018 curiumâ¢
Package Label Principal Display Panel:
Principal display panel technescan⢠hdp kit for the preparation of technetium tc 99m oxidronate sterile, 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 2 â 2h 2 o), 0.297 mg, theoretical, stannous chloride (sncl 2 â 2h 2 o), with 0.343 mg, maximum tin chloride [stannous and stannic] dihydrate as sncl 2 â 2h 2 o. in addition, each vial contains 0.84 mg gentisic acid (stabilizer) and 30.0 mg sodium chloride. the ph is adjusted with hci and/or naoh. contents are lyophilized and sealed under nitrogen. use within 8 hours of preparation. manufactured by: curium us llc maryland heights, mo 63043 made in usa curium⢠a091v0 r12/2018 display panel a091vo