Technescan Pyp
Technetium Tc 99m Pyrophosphate
Curium Us Llc
Human Prescription Drug
NDC 69945-094Technescan Pyp also known as Technetium Tc 99m Pyrophosphate is a human prescription drug labeled by 'Curium Us Llc'. National Drug Code (NDC) number for Technescan Pyp is 69945-094. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Technescan Pyp drug includes Sodium Pyrophosphate - 11.9 mg/10mL Stannous Chloride - 3.2 mg/10mL . The currest status of Technescan Pyp drug is Active.
Drug Information:
| Drug NDC: | 69945-094 |
| 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 Pyp |
| 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 Pyrophosphate |
| 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: | SODIUM PYROPHOSPHATE - 11.9 mg/10mL
STANNOUS CHLORIDE - 3.2 mg/10mL
|
| 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: | 14 Oct, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | NDA017538 |
| 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: | O352864B8Z
1BQV3749L5
|
| 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 |
|---|
| 69945-094-20 | 5 VIAL in 1 CELLO PACK (69945-094-20) / 10 mL in 1 VIAL | 14 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 pyp technetium tc 99m pyrophosphate sodium pyrophosphate pyrophosphoric acid stannous chloride stannous cation hydrochloric acid
Indications and Usage:
Indications and usage technetium tc 99m pyrophosphate injection is a skeletal imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. as an adjunct in the diagnosis of confirmed myocardial infarction (ecg and serum enzymes positive), the incidence of false negative images has been found to be 6%. false negative images can also occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. in a limited study involving 22 patients in whom the ecg was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the incidence of false negative images was 23%. the incidence of false positive images has been found to be 7 to 9%. false positive images have been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusion
Read more...s. technescan pyp is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. when administered intravenously 15 to 30 minutes prior to intravenous administration of sodium pertechnetate tc 99m for in vivo red blood cell labeling, approximately 75% of the injected activity remains in the blood pool. the modified in vivo/in vitro red blood cell labeling method may also be used for blood pool imaging.
Warnings:
Warnings reports indicate impairment of brain images using sodium pertechnetate tc 99m, which have been preceded by a bone image. the impairment may result in false positives or false negatives. it is recommended, where feasible, that brain imaging precede bone imaging procedures. preliminary reports indicate impairment of blood pool images in patients receiving sodium heparin for anticoagulant therapy. this is characterized by a reduction in the amount of injected radioactivity remaining in the blood pool. technescan pyp should be injected by direct venipuncture. heparinized catheter systems should be avoided.
General Precautions:
General technescan pyp should not be used more than six hours after preparation. 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. the contents of this kit are not radioactive. however, after sodium pertechnetate tc 99m is added, adequate shielding of the final preparation must be maintained. the imaging of gastrointestinal bleeding is dependent on such factors as the region of imaging, rate and volume of the bleed, efficacy of labeling of the red blood cells and timeliness of imaging. due to these factors, images should be taken sequentially over a period of time until a positive image is obtained or clinical conditions warrant the discontinuance of the procedure. the period of time for collecting the images may range up to thirty-six hours. any sodium pertechnetate tc 99m solution which contains an oxidizing agent is not suitable for use in the preparation
Read more...of technetium tc 99m pyrophosphate injection. the contents of the technescan pyp reaction vial may be used for the preparation of technetium tc 99m pyrophosphate injection. technescan pyp may also be reconstituted with sterile, non-pyrogenic normal saline containing no preservatives and injected intravenously prior to labeling of red blood cells with sodium pertechnetate tc 99m using either the in vivo or modified in vivo/in vitro method. as in the use of any other radioactive material, care should be taken to ensure minimum radiation exposure to the patient, consistent with proper patient management, and to ensure minimum radiation exposure to occupational workers. radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Dosage and Administration:
Dosage and administration bone and cardiac imaging the recommended adult doses of technetium tc 99m pyrophosphate injection are: indication doses as technetium tc 99 fraction of vial contents required skeletal imaging 185 to 555 megabecquerels (5 to 15 mci) 0.07 to 0.91 cardiac imaging 370 to 555 megabecquerels (10 to 15 mci) 0.26 to 0.45 technetium tc 99m pyrophosphate injection is injected intravenously over a 10- to 20-second period. for optimal results, bone imaging should be done one to six hours following administration. cardiac imaging should be done 60 to 90 minutes following administration. the acute myocardial infarct can be visualized from 24 hours to nine days following onset of symptoms, with maximum localization at 48 to 72 hours. cardiac imaging should be done with a gamma scintillation camera. it is recommended that images be made of the anterior, left anterior oblique and left lateral projections. the patient dose should be measured by a suitable radioactivity calibrat
Read more...ion system immediately prior to administration. it is also recommended that the radiochemical purity be checked prior to administration. blood pool imaging the recommended adult dose of technescan pyp is one-third (0.33) to the entire vial contents, followed by 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate tc 99m. cardiac imaging should be done 10 minutes following the administration of sodium pertechnetate tc 99m (in vivo method) or tc 99m labeled red blood cells (modified in vivo/in vitro method) utilizing a scintillation camera interfaced to an electrocardiographic gating device. in vivo method: technescan pyp is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives. the patient dose is administered intravenously 15 to 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate tc 99m. technescan pyp should be injected by direct venipuncture. heparinized catheter systems should be avoided. modified in vivo/in vitro method using acid-citrate-dextrose (acd): technescan pyp is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. an intravenous line containing a 3-way stopcock is inserted in a large peripheral vein and kept patent with a continuous drip of sterile, non-pyrogenic normal saline containing no preservatives. thirty minutes after technescan pyp injection, the infusion line and stopcock are cleared by withdrawing and discarding approximately 5 milliliters of whole blood. immediately following, approximately 5 milliliters of whole blood are withdrawn into a syringe containing 1 milliliter preservative-free acid-citrate-dextrose (acd) and 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate tc 99m. the stopcock is then turned, residual blood is flushed from the intravenous line, and the normal saline flow is readjusted. the syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock. modified in vivo/in vitro method using heparin: technescan pyp is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. an infusion set fitted with a 3-way stopcock is placed in a large peripheral vein, and the intravenous line is heparinized with a saline solution containing 5 to 10 units preservative-free heparin per milliliter. thirty minutes after technescan pyp injection, 3 milliliters of blood are withdrawn into a syringe containing 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate tc 99m. anticoagulation of the blood is provided by residual heparin in the intravenous line. the syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock. parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. do not use if contents are turbid.
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions several adverse reactions due to the use of technetium tc 99m pyrophosphate injection have been reported. these were usually flushing, hypotension, fever, chills, nausea, vomiting and dizziness, as well as hypersensitivity reactions such as itching and various skin rashes.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with technetium tc 99m pyrophosphate injection. it is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. technetium tc 99m pyrophosphate injection 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.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Overdosage:
Overdosage in case of overdose of technetium tc 99m pyrophosphate, encourage patients to maintain hydration and to void frequently to minimize radiation exposure.
Description:
Description technescan⢠pyp⢠(kit for the preparation of technetium tc 99m pyrophosphate injection) is a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous administration after reconstitution with sterile sodium pertechnetate tc 99m injection or sterile 0.9% sodium chloride injection. each 10 milliliter reaction vial contains 11.9 milligrams sodium pyrophosphate, 3.2 milligrams (minimum) stannous chloride (sncl 2 â¢2h 2 o) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (sncl 2 â¢2h 2 o) in lyophilized form under an atmosphere of nitrogen. prior to lyophilization the ph is adjusted with hydrochloric acid. the ph of the reconstituted drug is between 4.5 and 7.5. no bacteriostatic preservative is present. the precise structures of the stannous-pyrophosphate and technetium-stannous-pyrophosphate complexes are not known at this time.
Clinical Pharmacology:
Clinical pharmacology when injected intravenously, technetium tc 99m pyrophosphate has a specific affinity for areas of altered osteogenesis. it is also concentrated in the injured myocardium, primarily in areas of irreversibly damaged myocardial cells. one to two hours after intravenous injection of technetium tc 99m pyrophosphate, an estimated 40 to 50% of the injected dose had been taken up by the skeleton, and approximately 0.01 to 0.02% per gram of acutely infarcted myocardium. within a period of one hour, 10 to 11% remains in the vascular system, declining to approximately 2 to 3% twenty-four hours post injection. the average urinary excretion was observed to be about 40% of the administered dose after 24 hours. technescan pyp also has an affinity for red blood cells. when administered 15 to 30 minutes prior to the intravenous administration of sodium pertechnetate tc 99m (in vivo red blood cell labeling), approximately 75% of the injected radioactivity remains in the blood pool
Read more...providing excellent images of the cardiac chambers. when the modified in vivo/in vitro red blood cell labeling method is used, comparable percentages of the injected radioactivity are obtained. toxicology data are available upon request.
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 this drug affects fertility in males or females.
How Supplied:
How supplied catalog number 094. technescan pyp is supplied as a lyophilized powder packaged in vials. each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (sncl 2 â¢2h 2 o) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (sncl 2 â¢2h 2 o), sealed under an atmosphere of nitrogen. prior to lyophilization the ph is adjusted with hydrochloric acid. the ph of the reconstituted drug is between 4.5 and 7.5. kit containing 5 vials is available. storage the technescan pyp kit must be maintained in a refrigerator, 2° to 8°c (36° to 46°f) until use. the reconstituted vial should be stored at controlled room temperature, 20° to 25°c (68° to 77°f).
Package Label Principal Display Panel:
Principal display panel - a094v0 technescan⢠pyp⢠(stannous pyrophosphate) vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (sncl 2 â¢2h 2 o) and 4.4 mg (maximum) total tin as stannous chloride (sncl 2 â¢2h 2 o). prior to lyophilization the ph is adjusted with hydrochloric acid. the ph of the reconstituted drug is between 4.5 and 7.5. the contents are sealed under nitrogen. sterile, non-pyrogentic. for intravenous use after drug preparation. see package insert for directions for use. do not use tc 99m solutions containing an oxidizing agent. rx only store refrigerated at 2° to 8°c (36° to 46°f). manufactured by: curium us llc maryland heights, mo 63043 made in usa curium⢠a094v0 r12/2018 display panel a094vo