Gallium Citrate Ga-67
Curium Us Llc
Human Prescription Drug
NDC 69945-180Gallium Citrate Ga-67 is a human prescription drug labeled by 'Curium Us Llc'. National Drug Code (NDC) number for Gallium Citrate Ga-67 is 69945-180. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Gallium Citrate Ga-67 drug includes Gallium Chloride Ga-67 - 2 mCi/mL . The currest status of Gallium Citrate Ga-67 drug is Active.
Drug Information:
| Drug NDC: | 69945-180 |
| 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: | Gallium Citrate Ga-67 |
| 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: | Gallium Citrate Ga-67 |
| 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, 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: | GALLIUM CHLORIDE GA-67 - 2 mCi/mL
|
| 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: | 21 Feb, 2008 |
| 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: | NDA018058 |
| 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: | A04B19O2B0
|
| 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 |
|---|
| 69945-180-06 | 1 VIAL in 1 CAN (69945-180-06) / 3.3 mL in 1 VIAL | 21 Feb, 2008 | N/A | No |
| 69945-180-12 | 1 VIAL in 1 CAN (69945-180-12) / 6.6 mL in 1 VIAL | 21 Feb, 2008 | 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:
Gallium citrate ga-67 gallium citrate ga-67 gallium chloride ga-67 gallium cation ga-67 trisodium citrate dihydrate sodium chloride benzyl alcohol hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage gallium citrate ga 67 injection may be useful to demonstrate the presence and extent of hodgkin's disease, lymphoma, and bronchogenic carcinoma. positive gallium ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. gallium citrate ga 67 injection may be useful as an aid in detecting some acute inflammatory lesions.
Warnings:
Warnings none known.
General Precautions:
General a thorough knowledge of the normal distribution of intravenously administered gallium citrate ga 67 injection is essential in order to accurately interpret pathologic states. the finding of an abnormal gallium ga-67 concentration usually implies the existence of underlying pathology, but further diagnostic studies should be done to distinguish benign from malignant lesions. gallium citrate ga 67 injection is intended for use as an adjunct in the diagnosis of certain neoplasms as well as focal areas of infection. certain pathologic conditions may yield up to 40 percent false negative gallium ga-67 studies. therefore, a negative study cannot be definitely interpreted as ruling out the presence of disease. lymphocytic lymphoma frequently does not accumulate gallium ga-67 sufficiently for unequivocal imaging and the use of gallium with this histologic type of lymphoma is not recommended at this time. gallium ga-67 localization cannot differentiate between tumor and acute inflammati
Read more...on, and other diagnostic studies must be added to define the underlying pathology. as in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper management and to ensure minimum radiation exposure to occupational workers. the vial contents are sterile and non-pyrogenic. it is essential that the user follow the directions carefully and adhere to strict aseptic procedures. radiopharmaceuticals should be used only by physicians who are qualified by training and experience 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 the recommended adult (70 kg) dose of gallium citrate ga 67 injection is 74 to 185 megabecquerels (2 to 5 millicuries). gallium citrate ga 67 injection is intended for intravenous administration only. approximately 10 percent of the administered dose is excreted in the feces during the first week after injection. daily laxatives and/or enemas are recommended from the day of injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies. studies indicate the optimal tumor to background concentration ratios are often obtained 48 hours post injection. however, considerable biological variability may occur in individuals and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection. the patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. parenteral drug products should be in
Read more...spected visually for particulate matter and discoloration prior to administration. do not use if contents are turbid. instructions for the handling of gallium citrate ga 67: waterproof gloves should be used during the entire handling and administration procedure. using proper shielding, the vial containing the gallium citrate ga 67 should be visually inspected to ensure that it is free of particulate matter and discoloration prior to use. maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation. radiation dosimetry the estimated absorbed radiation doses mird dose estimate report no. 2, j. nucl. med. 14; 755-6 (1973). from an intravenous injection of 185 megabecquerels (5 millicuries) of gallium citrate ga 67 are shown in table 4. table 4. absorbed radiation doses tissue mgy/ 185mbq rads/ 5mci whole body 13.0 1.30 skeleton 22.0 2.20 liver 23.0 2.30 bone marrow 29.0 2.90 spleen 26.5 2.65 kidney 20.5 2.05 ovaries 14.0 1.40 testes 12.0 1.20 gastrointestinal tract stomach 11.0 1.10 small intestine 18.0 1.80 upper large intestine 28.0 2.80 lower large intestine 45.0 4.50
Contraindications:
Contraindications none.
Adverse Reactions:
Adverse reactions rare occurrences of allergic reactions, skin rash and nausea have been reported in association with gallium citrate ga 67 use.
Use in Pregnancy:
Pregnancy category c animal reproductive studies have not been conducted with gallium citrate ga 67. it is also not known whether gallium citrate ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. gallium citrate ga 67 should be given to a pregnant woman only if clearly needed. ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first few (approximately ten) days following the onset of menses.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients below the age of 18 have not been established.
Description:
Description gallium citrate ga 67 injection is supplied in a 10 milliliter vial as an isotonic, sterile, non-pyrogenic solution. each milliliter of the isotonic solution contains 74 megabecquerels (2 millicuries) of gallium ga-67 on the calibration date as a complex formed from 8.3 nanograms gallium chloride ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride and 0.9 percent benzyl alcohol (v/v) as a preservative. the ph is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution. gallium ga-67, with a half-life of 78.26 hours, is cyclotron produced by the proton irradiation of enriched zinc. at the time of calibration the drug contains no more than 0.02% gallium ga-66 and no more than 0.2% zinc zn-65. the concentration of each radionuclidic impurity changes with time. at expiration, the drug contains no more than 0.001% gallium ga-66 and no more than 1.0% zinc zn-65. no carrier has been added. gallium citrate has the following chemical structure: chemical structure physical characteristics gallium ga-67 with a physical half-life of 78.26 hours kocher, d.c., radioactive decay data tables, health and safety research division, national technical information service, doe/tic-11026, pg. 80, 1981. decays by electron capture to stable zinc zn-67. photons that are useful for imaging studies are listed in table 1. table 1. principal radiation emission data radiation mean percent per disintegration energy (kev) gamma-2 2.9 91.3 gamma-3 35.7 93.3 gamma-4 19.7 184.6 gamma-5 2.2 209.0 gamma-6 16.0 300.2 gamma-7 4.5 393.5 external radiation the specific gamma ray constant for gallium ga-67 is 1.6 r/mci-hour at 1 cm. the first half-value thickness of lead (pb) is 0.066 cm. a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in table 2. for example, the use of 1.2 cm of lead will decrease the radiation exposure by a factor of about 100. table 2. radiation attenuation by lead shielding shield thickness (pb), cm coefficient of attenuation 0.066 0.41 1.2 2.5 4.8 0.5 10 -1 10 -2 10 -3 10 -4 to correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in table 3. table 3. physical decay chart; gallium ga-67, half-life 78.26 hours hours fraction remaining hours fraction remaining 0* 6 12 18 24 (1d) 30 36 42 48 (2d) 54 60 66 1.000 0.948 0.899 0.853 0.809 0.767 0.727 0.689 0.654 0.620 0.588 0.557 72 (3d) 78 84 90 96 (4d) 108 120 (5d) 132 144 (6d) 156 168 (7d) 0.529 0.501 0.475 0.451 0.427 0.384 0.345 0.311 0.279 0.251 0.226 * calibration time
Clinical Pharmacology:
Clinical pharmacology gallium citrate ga 67, with no carrier added, has been found to concentrate in certain viable primary and metastatic tumors as well as focal sites of infection. the mechanism of concentration is unknown, but investigational studies have shown that gallium ga-67 accumulates in lysosomes and is bound to a soluble intracellular protein. it has been reported in the scientific literature that following intravenous injection, the highest tissue concentration of gallium ga-67 - other than tumors and sites of infection - is the renal cortex. after the first day, the maximum concentration shifts to bone and lymph nodes and after the first week, to liver and spleen. gallium ga-67 is excreted relatively slowly from the body. the average whole body retention is 65 percent after seven days, with 26 percent having been excreted in the urine and 9 percent in the stools.
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 180. gallium citrate ga 67 injection is supplied sterile and non-pyrogenic for intravenous use. each milliliter contains 74 megabecquerels (2 millicuries) of gallium ga-67 on the calibration date, as a complex formed from 8.3 nanograms gallium chloride ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride, and 0.9 percent benzyl alcohol (v/v) as a preservative. the ph is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution. gallium citrate ga 67 injection is available in vials containing the following amounts on the calibration date. catalog no. n180g0 222 megabecquerels (6 mci) ndc 69945-180-06 n180m0 444 megabecquerels (12 mci) ndc 69945-180-12 storage and handling the contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained. store at controlled room temperature 20° to 25°c (68° to 77°f) [see usp]. storage and disposal of gallium cit
Read more...rate ga 67 injection should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. curium and the curium logo are trademarks of a curium company. ©2018 curium us llc. all rights reserved. manufactured by: curium us llc maryland heights, mo 63043 made in usa a180i0 r12/2018 curium tm
Package Label Principal Display Panel:
Principal display panel - a180c0 gallium citrate ga 67 injection diagnostic sterile, non-pyrogenic solution for intravenous administration store at controlled room temperature 20 ° to 25°c (68 ° to 77°f). each mililiter contains 74 mbq (2 mci) gallium citrate ga 67 (essentially carrier free) at date and time of calibration, as a complex formed from 8.3 ng gallium chloride ga 67, 1.9 mg sodium citrate dihydrate, 7.8 mg sodium chloride, and 0.9% (v/v), benzyl alcohol as a preservative. sodium hydroxide or hydrochloric acid are added for ph adjustment. the ph is between 5.5 and 8.0. for information on dosage, administration and indications see package insert. rx only. warning: radioactive drugs must be handled only by qualified personnel in conformity with regulations of the u.s. nuclear regulatory commission or state regulatory agencies where applicable. bottle containing drug should be kept in this container or within heavier shield. manufactured by: curium us llc maryland heights, mo 63043 made in usa curium tm caution radioactive material a180c0 r12/2018 a180c0-cn0000-us122018 spl a180c0-cn0000-us122018 spl