Draximage Maa
Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Human Prescription Drug
NDC 65174-270Draximage Maa also known as Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated is a human prescription drug labeled by 'Jubilant Draximage Inc., Dba Jubilant Radiopharma'. National Drug Code (NDC) number for Draximage Maa is 65174-270. This drug is available in dosage form of Injection, Powder, For Solution. The names of the active, medicinal ingredients in Draximage Maa drug includes Albumin Aggregated - 2.5 mg/1 . The currest status of Draximage Maa drug is Active.
Drug Information:
| Drug NDC: | 65174-270 |
| 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: | Draximage Maa |
| 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: | Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Jubilant Draximage Inc., Dba Jubilant Radiopharma |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Powder, 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: | ALBUMIN AGGREGATED - 2.5 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: | BLA |
| 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: | 30 Dec, 1987 |
| 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: | BLA017881 |
| 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: | Jubilant DraxImage Inc., dba Jubilant Radiopharma
|
| 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: | 799C8VF17R
|
| 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 |
|---|
| 65174-270-30 | 30 INJECTION, POWDER, FOR SOLUTION in 1 KIT (65174-270-30) | 30 Dec, 1987 | 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:
Draximage maa kit for the preparation of technetium tc 99m albumin aggregated albumin aggregated albumin aggregated stannous chloride albumin human sodium chloride
Indications and Usage:
Indications and usage technetium tc 99m albumin aggregated injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. technetium tc 99m albumin aggregated injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (leveen) shunt patency.
Warnings:
Warnings although adverse reactions specifically attributable to technetium tc 99m albumin aggregated injection have not been noted, the literature contains reports of deaths occurring after the administration of albumin aggregated to patients with pre-existing severe pulmonary hypertension. instances of hemodynamic or idiosyncratic reactions to preparations of technetium tc 99m albumin aggregated have been reported.
Dosage and Administration:
Dosage and administration the recommended intravenous dose range for the average (70 kg) adult patient for lung imaging is 37 to 148 megabecquerels (1 to 4 millicuries) of technetium tc 99m albumin aggregated injection after reconstitution with oxidant-free sodium pertechnetate tc 99m injection. the suggested intraperitoneal dosage range used in the average patient (70 kg) for peritoneovenous (leveen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3 millicuries). adequate measures should be taken to assure uniform mixing with peritoneal fluid. serial images of both the shunt and target organ should be obtained and correlated with other clinical findings. alternatively, the drug may be administered by percutaneous transtubal injection. the suggested percutaneous transtubal (efferent limb) dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1 millicurie) in a volume not to exceed 0.5 ml. the recommended number of particles per single injection is 2
Read more...00,000 to 700,000 with the suggested number being approximately 350,000. depending on the activity added and volume of the final reconstituted product, the volume of the dose may vary from 0.2 to 1.9 ml. the number of particles available per dose of technetium tc 99m albumin aggregated injection will vary depending on the physical decay of the technetium tc-99m that has occurred. the number of particles in any dose and volume to be administered may be calculated as follows: where: v tc = volume of solution added to reaction vial d = desired dose to be administered in mbq (mci) c = concentration at calibration time of sodium pertechnetate solution to be added to the reaction vial in mbq/ml (mci/ml) v a = volume to be administered in ml p = number of particles in dose to be administered f r = fraction of technetium tc-99m remaining after the time of calibration (see table 3) n = number of particles per vial. the number of particles per vial for each lot is shipped with the product. in pediatric patients, the suggested intravenous dose to be employed for perfusion lung imaging is in the range of 0.925 to 1.85 mbq per kilogram (25 to 50 μci/kg) of body weight; a usual dose is 1.11 mbq per kilogram (30 μci/kg), except in newborns, in whom the administered dose should be 7.4 to 18.5 mbq (200 to 500 μci). not less than the minimum dose of 7.4 mbq (200 μci) should be employed for this procedure. the number of particles will vary with age and weight of the pediatric patient as indicated in table 5. parenteral drug products should be visually inspected 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. mix the contents of the vial by gentle inversion just prior to withdrawing a patient dose. mix the contents of the syringe just before injection. if blood is drawn into the syringe, any unnecessary delay prior to injection may lead to clot formation. for optimum results and because of rapid lung clearance of the radiopharmaceutical, it is suggested that the patient be positioned under the imaging apparatus before administration. slow injection is recommended. lung imaging may begin immediately after intravenous injection of the radiopharmaceutical. due to high kidney uptake, imaging later than one-half hour after administration will yield poor results. radiation dosimetry the estimated absorbed radiation doses 1 to an average adult patient (70 kg) from an intravenous injection of 148 mbq (4 mci) of technetium tc 99m albumin aggregated injection are shown in table 4. table 4 - absorbed radiation doses organs mgy/148 mbq rad/4 mci total body lungs liver spleen kidneys bladder wall 2 hr. void 4.8 hr. void testes 2 hr. void 4.8 hr. void ovaries 2 hr. void 4.8 hr. void 0.6 8.8 0.72 0.68 0.44 1.2 2.2 0.24 0.26 0.3 0.34 0.06 0.88 0.072 0.068 0.044 0.12 0.22 0.024 0.026 0.03 0.034 1 method of calculation: âsâ absorbed dose per unit cumulated activity for selected radionuclides and organs, mird pamphlet no. 11 (1975). in pediatric patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 mbq (50 μci) per kilogram of body weight [except in the newborn where the maximum recommended dose of 18.5 mbq (500 μci) is used] and are shown in table 5, which lists the maximum dose for pediatric patients from newborn to adults. note the recommendations regarding number of particles to be administered. table 6 represents the absorbed radiation dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of technetium tc 99m albumin aggregated. table 5 - pediatric radiation dose from tc 99m maa for lung imaging* (1) 2 hour voiding interval (2) 4.8 hour voiding interval age newborn 1 year 5 years 10 years 15 years weight (kg) 3.5 12.1 20.3 33.5 55 max. recommended dose in megabecquerels and millicuries mbq 18.5 mci 0.5 mbq 22.2 mci 0.6 mbq 37 mci 1 mbq 62.9 mci 1.7 mbq 103.6 mci 2.8 range of particles administered 10,000 to 50,000 50,000 to 150,000 200,000 to 300,000 200,000 to 300,000 200,000 to 700,000 absorbed radiation dose in milligray and rad for the maximum dose mgy rad mgy rad mgy rad mgy rad mgy rad organs total body lungs liver bladder wall ovaries testes 0.6 19 1.4 2.1 0.38 0.31 0.06 1.9 0.14 0.21 (1) 0.038 0.031 0.3 6.6 0.6 1.5 0.2 0.13 0.03 0.66 0.06 0.15 (1) 0.02 0.013 0.31 5.8 0.62 3.1 0.19 0.19 0.031 0.58 0.062 0.31 (2) 0.019 0.019 0.48 8.7 1.8 3.9 0.44 0.2 0.048 0.87 0.18 0.39 (2) 0.044 0.02 0.41 7.7 1.2 4.1 0.41 0.36 0.041 0.77 0.12 0.41 0.041 0.036 *assumptions: 1. used biologic data from kaul et al ., berlin, 1973. 2. for the newborn, 1-year old, and 5-year old, the âsâ values calculated from the preliminary phantoms of ornl were used. the 10-year old, 15-year old and adult âsâ values were taken from henrichs et al. , berlin, 1980. table 6 - absorbed radiation doses* organs shunt patency (open) shunt patency (closed) mgy rad mgy rad lung ovaries & testes organs in the peritoneal cavity total body 6.9 0.18 to 0.3 - 0.36 0.69 0.018 to 0.03 - 0.036 1.68 1.68 1.68 0.57 0.168 0.168 0.168 0.057 *assumptions: calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the peritoneal cavity with no biological clearance. choose image
Contraindications:
Contraindications technetium tc 99m albumin aggregated injection should not be administered to patients with severe pulmonary hypertension. the use of technetium tc 99m albumin aggregated injection is contraindicated in persons with a history of hypersensitivity reactions to products containing human serum albumin.
Adverse Reactions:
Adverse reactions the literature contains reports of deaths occurring after the administration of albumin aggregated to patients with pre-existing severe pulmonary hypertension. instances of hemodynamic or idiosyncratic reactions to preparations of technetium tc 99m albumin aggregated have been reported (see warnings ).
Description:
Draximage ® m aa kit for the preparation of technetium tc 99m albumin aggregated injection diagnostic - for intravenous use description the kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce technetium tc 99m albumin aggregated injection for diagnostic use by intravenous injection. each 10 ml reaction vial contains 2.5 mg of albumin aggregated, 5 mg of human serum albumin , 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an atmosphere of nitrogen. sodium hydroxide or hydrochloric acid has been used for ph adjustment. no bacteriostatic preservative is present. the human serum albumin was non-reactive when tested for hepatitis b surface antigen (hb s ag), antibodies to human immunodeficiency virus (hiv-1/hiv-2), antibody to hepatitis c virus (anti-hcv) and antigen to human immunodeficiency virus (hiv-1). the aggregated particles are formed by denaturation of the albumin in a heating and aggregation process. each vial contains 3 to 8 million particles. by light microscopy, more than 90% of the particles are between 10 and 70 micrometers, while the typical average size is 20 to 40 micrometers; none is greater than 150 micrometers. technetium tc 99m albumin aggregated injection for intravenous use is in its final dosage form when a sterile isotonic sodium pertechnetate solution is added to the vial. no less than 90% of the pertechnetate tc-99m added to a reaction vial is bound to aggregate at preparation time and remains bound throughout the usage lifetime of the preparation (see directions for preparation). physical characteristics technetium tc-99m decays by isomeric transition with a physical half-life of 6.02 hours. the principal photon that is useful for detection and imaging studies is listed in table 1. table 1 - principal radiation emission data radiation mean %/disintegration mean energy (kev) gamma 89.07 140.5 external radiation the specific gamma ray constant for technetium tc-99m is 0.78 r/mci-hr at 1 cm. the first half value layer is 0.017 cm of lead. a range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in table 2. for example, the use of 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1,000. table 2 - radiation attenuation by lead (pb) shielding shield thickness (pb) cm coefficient of attenuation 0.017 0.08 0.16 0.25 0.33 0.5 10 -1 10 -2 10 -3 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 calibration time 1 2 3 4 1.000 0.891 0.794 0.708 0.631 5 6 8 10 12 0.562 0.501 0.398 0.316 0.251
Clinical Pharmacology:
Clinical pharmacology immediately following intravenous injection, more than 80% of the albumin aggregated is trapped in the pulmonary alveolar capillary bed. the imaging procedure can thus be started as soon as the injection is complete. assuming that a sufficient number of radioactive particles has been used, the distribution of radioactive aggregated particles in the normally perfused lung is uniform throughout the vascular bed, and will produce a uniform image. areas of reduced perfusion will be revealed by a corresponding decreased accumulation of the radioactive particles, and are imaged as areas of reduced photon density. organ selectivity is a direct result of particle size. below 1 to 10 micrometers, the material is taken up by the reticuloendothelial system. above 10 micrometers, the aggregates become lodged in the lung by a purely mechanical process. distribution of particles in the lungs is a function of regional pulmonary blood flow. the albumin aggregated is sufficiently
Read more...fragile for the capillary micro-occlusion to be temporary. erosion and fragmentation reduce the particle size, allowing passage of the aggregates through the pulmonary alveolar capillary bed. the fragments are then accumulated by the reticuloendothelial system. lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. elimination of the technetium tc 99m aggregated albumin from the lungs occurs with a half-life of about 2 to 3 hours. cumulative urinary excretion studies show an average of 20% elimination of the injected technetium tc 99m dose 24 hours post-administration. following administration of technetium tc 99m albumin aggregated by intraperitoneal injection, the radiopharmaceutical mixes with the peritoneal fluid. clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent. serial images should be obtained of both the shunt and lung (target organ). however, an adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases.
How Supplied:
How supplied draximage® maa (ndc 65174.270.30) comprises: 30 multi-dose glass vials. each vial contains a non-radioactive sterile, non-pyrogenic lyophilized mixture of: 2.5 mg of albumin aggregated, 5 mg of human serum albumin, 0.06 mg (minimum) of stannous chloride (maximum stannous and stannic chloride 0.11 mg), and 1.2 mg of sodium chloride; 30 radiation labels; 1 package insert. hcl and/or naoh has been used for ph adjustment. the vials are sealed under an atmosphere of nitrogen.
Package Label Principal Display Panel:
Maa vial label (inner label) label
Maa carton carton
Maa post-reconstitution label carton