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gallium citrate ga-67
Overview
What is GALLIUM CITRATE GA-67?
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:
What does GALLIUM CITRATE GA-67 look like?
What are the available doses of GALLIUM CITRATE GA-67?
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What should I talk to my health care provider before I take GALLIUM CITRATE GA-67?
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How should I use GALLIUM CITRATE GA-67?
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.
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 inspected 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:
What interacts with GALLIUM CITRATE GA-67?
None.
What are the warnings of GALLIUM CITRATE GA-67?
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.
What are the precautions of GALLIUM CITRATE GA-67?
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 inflammation, 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.
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.
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.
Nursing Mothers
This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 18 have not been established.
What are the side effects of GALLIUM CITRATE GA-67?
Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.
What should I look out for while using GALLIUM CITRATE GA-67?
None.
None known.
What might happen if I take too much GALLIUM CITRATE GA-67?
Sorry No Records found
How should I store and handle GALLIUM CITRATE GA-67?
Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.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 69945-180-12Catalog 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 69945-180-12Catalog 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 69945-180-12Catalog 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
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
None.None known.
Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see ).
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 inflammation, 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.
Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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