Ultratag Rbc
Technetium Tc 99m-labeled Red Blood Cells
Curium Us Llc
Human Prescription Drug
NDC 69945-068Ultratag Rbc also known as Technetium Tc 99m-labeled Red Blood Cells is a human prescription drug labeled by 'Curium Us Llc'. National Drug Code (NDC) number for Ultratag Rbc is 69945-068. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Ultratag Rbc drug includes . The currest status of Ultratag Rbc drug is Active.
Drug Information:
| Drug NDC: | 69945-068 |
| 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: | Ultratag Rbc |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Ultratag |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | RBC |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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-labeled Red Blood Cells |
| 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: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 10 Jun, 1991 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 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: | NDA019981 |
| 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: | |
| 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 |
|---|
| 69945-068-20 | 5 CELLO PACK in 1 BOX (69945-068-20) / 1 KIT in 1 CELLO PACK * .6 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS * 9.5 mg in 1 VIAL, GLASS | 10 Jun, 1991 | 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:
Ultratag rbc technetium tc 99m-labeled red blood cells rbc reaction vial rbc reaction vial stannous chloride stannous cation anhydrous dextrose trisodium citrate dihydrate sodium hydroxide sodium hypochlorite sodium hypochlorite sodium hypochlorite water sodium hydroxide acd acd citric acid monohydrate trisodium citrate dihydrate water anhydrous dextrose
Indications and Usage:
Indications and usage technetium tc 99m-labeled red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.
Warnings:
Warnings none known.
General Precautions:
General the components of the kit are sterile and nonpyrogenic. it is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. the contents of the kit are intended only for use in the preparation of technetium tc 99m-labeled red blood cells and are not to be administered directly to the patient. the contents of this kit are not radioactive. after sodium pertechnetate tc 99m is added, however, adequate shielding of the final preparation must be maintained. technetium tc 99m-labeled red blood cells must be handled with care to ensure minimum radiation exposure to the patient, consistent with proper patient management, and to ensure minimum radiation exposure to occupational workers. the labeled red blood cells must be reinjected only into the patient from whom the blood was drawn. nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. procedures shou
Read more...ld be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. a system of checks similar to the ones used for administering blood transfusions should be routine. clinical trials were conducted with a variety of prescription and nonprescription medications and showed no significant effect on the in vitro labeling efficiency of ultratag⢠rbc. unlike stannous pyrophosphate red blood cell kits, heparinized patients (11) showed minimal interference with ultratag⢠rbc labeling efficiency (95% with heparin, 97% without heparin). it is recommended that the labeled red blood cells be administered within 30 minutes of preparation or as soon as possible thereafter. a small study showed that technetium tc 99m-labeled red blood cells prepared with ultratag⢠rbc have equivalent in vivo labeling efficiency when administered both immediately after preparation (5 patients studied) and at 6 hours after preparation (6 patients studied) with a 24-hour labeling efficiency averaging 97% for both groups. radiopharmaceuticals 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.
Dosage and Administration:
Dosage and administration the instructions for preparation must be carefully followed for preparing technetium tc 99m-labeled red blood cells using ultratag⢠rbc. the suggested dose range of technetium tc 99m-labeled red blood cells in the average patient (70 kg) is 370 mbq (10 mci) to 740 mbq (20 mci). 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. aseptic procedures and a shielded syringe should be employed in preparing and withdrawing doses for administration to patients. the user should wear waterproof gloves during the administration procedure.
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions none known.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with technetium tc 99m-labeled red blood cells. it is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. technetium 99m-labeled red blood cells should be administered 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 efficacy in pediatric patients have not been established.
Description:
Description ultratag⢠rbc (kit for the preparation of technetium tc 99m-labeled red blood cells) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of technetium tc 99m-labeled red blood cells. each kit consists of three separate nonradioactive components: a 10 milliliter reaction vial containing: stannous chloride, dihydrate (sncl 2 â¢2h 2 o) â 50 ug minimum stannous chloride, dihydrate (sncl 2 â¢2h 2 o) â 96 ug theoretical tin chloride (stannous and stannic), dihydrate (as sncl 2 â¢2h 2 o) â 105 ug maximum sodium citrate, dihydrate â 3.67 mg dextrose, anhydrous â 5.50 mg prior to lyophilization, the ph is adjusted to 7.1 to 7.2 with sodium hydroxide. the contents of the vial are lyophilized and stored under argon. syringe i contains: sodium hypochlorite â 0.6 mg in sterile water for injectionthe total volume of this syringe is 0.6 ml. sodium hydroxide may have been added for ph adjustment. the ph of this solution is 11 to 13. the syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite. syringe ii contains: citric acid, monohydrate â 8.7 mg sodium citrate, dihydrate â 32.5 mg dextrose, anhydrous â 12.0 mg in sterile water for injection the total volume of this syringe is 1.0 ml. the ph range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid.
Clinical Pharmacology:
Clinical pharmacology in vitro tc 99m red blood cell labeling is accomplished by adding 1.0 to 3.0 milliliters of autologous whole blood, anticoagulated with heparin or anticoagulant citrate dextrose solution (acd), to the reaction vial. a portion of the stannous ion in the reaction vial diffuses across the red blood cell membrane and accumulates intracellularly. the in vitro tc 99m red blood cell labeling efficiency can decrease in the presence of excess acd. excess acd apparently impairs the diffusion of stannous ion across the red blood cell membrane. therefore, the acd concentration used for blood collection should not exceed 0.15 ml acd per ml of blood. sodium hypochlorite is then added to the reaction vial to oxidize the extracellular stannous ion. since the hypochlorite does not cross the red blood cell membrane, the oxidation of stannous ion is selective for the extracellular tin. a citric acid, sodium citrate and dextrose solution is then added to the reaction vial to sequeste
Read more...r any residual extracellular stannous ion, rendering it more readily available for oxidation by sodium hypochlorite. radioactive labeling of the red blood cells is completed by addition of sodium pertechnetate tc 99m to the oxidized reaction vial. the pertechnetate tc 99m diffuses across the red blood cell membrane and is reduced by the intracellular stannous ion. the reduced technetium tc 99m cannot diffuse out of the red blood cell. the red blood cell labeling is essentially complete within 20 minutes of sodium pertechnetate tc 99m addition to the reaction vial. red blood cell labeling efficiency of â¥95% is typically obtained using this in vitro labeling procedure. in vitro tc 99m red blood cell labeling efficiency can decrease when excessive amounts of tc 99 are allowed to accumulate in the sodium pertechnetate tc 99m generator eluate; in this situation, efficiency decreases even further if excess (i.e. >0.15 ml per ml of blood) acd buffer is used. therefore, long tc 99 in-growth times are to be avoided; the use of fresh (â¤24 hour in-growth time) sodium pertechnetate tc 99m generator eluate is recommended. after the labeling procedure is completed, the technetium tc 99m-labeled red blood cells are then reinjected intravenously into the patient for gamma scintigraphic imaging. following intravenous injection, the technetium tc 99m-labeled red blood cells distribute within the blood pool with an estimated volume of distribution of approximately 5.6% of bodyweight. the technetium tc 99m is well retained in the blood pool with an estimated biological half-life of approximately 29 hours. of the total technetium tc 99m retained in the whole blood pool 24 hours after administration, 95% remains bound to the red blood cells. approximately 25% of the injected dose is excreted in the urine in the first 24 hours.
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 to determine the effects on male or female fertility.
How Supplied:
How supplied catalog number 068. ultratag⢠rbc consists of three separate nonradioactive components: a 10 milliliter reaction vial containing: stannous chloride, dihydrate (sncl 2 â¢2h 2 o) â 50 ug minimum stannous chloride, dihydrate (sncl 2 â¢2h 2 o) â 96 ug theoretical tin chloride (stannous and stannic), dihydrate (as sncl 2 â¢2h 2 o) â 105 ug maximum sodium citrate, dihydrate â 3.67 mg dextrose, anhydrous â 5.50 mg prior to lyophilization, the ph is adjusted to 7.1 to 7.2 with sodium hydroxide. the contents of the vial are lyophilized and stored under argon. syringe i contains: sodium hypochlorite â 0.6 mg in sterile water for injection the total volume of this syringe is 0.6 ml. sodium hydroxide may have been added for ph adjustment. the ph of this solution is 11 to 13. the syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite. syringe ii contains: citric acid, monohydrate â 8.7 m
Read more...g sodium citrate, dihydrate â 32.5 mg dextrose, anhydrous â 12.0 mg in sterile water for injection the total volume of this syringe is 1.0 ml. the ph range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid. storage the kit should be stored at controlled room temperature 20° to 25°c (68° to 77°f). syringe i should be protected from light if not stored in the kit tray. instructions for the preparation of technetium tc 99m-labeled red blood cells using ultratag⢠rbc collect patient's blood sample (1.0 to 3.0 ml) using heparin or acd as an anticoagulant. the amount of acd should not exceed 0.15 ml of acd per ml of blood. the recommended amount of heparin is 10-15 units per ml of blood. do not use edta or oxalate as an anticoagulant. using a large-bore (19 to 21 gauge) needle, transfer 1.0 to 3.0 ml of anticoagulated whole blood to the reaction vial and gently mix to dissolve the lyophilized material. allow to react for five minutes. add contents of syringe i, mix by gently inverting four to five times. add the contents of syringe ii to the reaction vial. mix by gently inverting four to five times. place the vial in a lead shield fitted with a lead cap and having a minimum wall thickness of 1/8 inch. add 370 to 3700 mbq (10 to 100 mci) sodium pertechnetate tc 99m (in a volume of up to 3 ml) to the reaction vial. the avoidance of long technetium tc 99 in-growth times and the use of fresh sodium pertechnetate tc 99m generator eluate is recommended. mix by gently inverting reaction vial four to five times. allow to react for 20 minutes with occasional mixing. technetium tc 99m-labeled red blood cells should be injected within 30 minutes of preparation or as soon as possible thereafter. if desired, assay labeling efficiency immediately prior to injection. typical labeling efficiency is greater than 95%. mix gently prior to withdrawal of patient dose. aseptically transfer the technetium tc 99m-labeled red blood cells to a syringe for administration to the patient. use largest bore needle compatible with patient administration to prevent hemolysis. assay the tc 99m-labeled red blood cell patient dose in a suitable calibrator and complete the radioassay information label. affix the radioassay information label to the shield.
Package Label Principal Display Panel:
Package label - principal display panel ultratag ⢠rbc kit for the preparation of technetium tc 99m labeled red blood cells sterile, non-pyrogenic. for intravenous use after drug preparation. see package insert for directions for use. do not use sodium pertechnetate tc 99m solutions containing an oxidizing agent. store at controlled room temperature 20º-25°c (68º-77°f). protect from light. rx only each kit contains: 1 10ml reaction vial containing stannous chloride, dihydrate (sncl 2 â¢2h 2 o) 50 µ g, minimum, stannous chloride, dihydrate (sncl 2 â¢2h 2 o) 96 µ g, theoretical, tin chloride (stannous, stannic) dihydrate, as stannous chloride, maximum dihydrate 105 µ g, 3.67 mg sodium citrate dihydrate and 5.50 mg anhydrous dextrose. the ph is adjusted to 7.1 to 7.2 with naoh prior to lyophilization. 1 syringe i each 0.6 ml contains 0.6 mg sodium hypochlorite (naocl). naoh may have been added for ph adjustment. the ph range of this solution is 11 to 13. total volume: 0.6 ml. protect from light. 1 syringe ii each milliliter contains 8.7 mg citric acid monohydrate, 32.5 mg sodium citrate dihydrate and 12.0 mg anhydrous dextrose. the ph is adjusted to 4.5 to 5.5 with sodium citrate or citric acid. total volume: 1.0 ml. 2 plastic syringe plunger rods 2 disposable hypodermic needles 1 package insert 1 radioassay information label manufactured by: curium us llc maryland heights, mo 63043 made in usa curium⢠a068k0 r12/2018 display panel a068ko