Trade Name: GALLIUM CITRATE GA-67

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Curium US LLC

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 2 mCi/mL

Storage and handling

GALLIUM CHLORIDE GA-67

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • 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:
  • 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.
  • 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.
  • None.
  • None known.
  • No data
  • Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.
  • 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:
  • The estimated absorbed radiation dosesfrom an intravenous injection of 185 megabecquerels (5 millicuries) of Gallium Citrate Ga 67 are shown in Table 4.
  • 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.n N180G0 222 megabecquerels (6 mCi)NDC 69945-180-06n N180M0 444 megabecquerels (12 mCi)NDC 69945-180-12
  • The contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP].
  • Storage and disposal of Gallium Citrate 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.u00a92018 Curium US LLC. All Rights Reserved.
  • Manufactured by:Curium USu00a0LLCMaryland Heights, MO 63043
  • Made in USA
  • A180I0
  • R12/2018
  • CURIUMu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Gallium Citrate Ga 67 Injection
  • DIAGNOSTICSterile, Non-Pyrogenic SolutionFor Intravenous AdministrationStore at Controlled Room Temperature 20 to 25u00b0C (68 to 77u00b0F).n- For information on dosage, administration and indications see package insert.n- Rx only.n- WARNING:
  • CURIUMn
  • CAUTION RADIOACTIVE MATERIALn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of gallium citrate ga-67 (GALLIUM CITRATE GA-67) which is also known as GALLIUM CITRATE GA-67 and Manufactured by Curium US LLC. It is available in strength of 2 mCi/mL.

gallium citrate ga-67 (GALLIUM CITRATE GA-67) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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