Gallium Citrate Ga 67

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.

None known.

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:

1. Waterproof gloves should be used during the entire handling and administration procedure.
2. 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.
3. Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation.

The estimated absorbed radiation doses2 from 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.

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 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.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.
© 2015 Mallinckrodt.

Manufactured by:
Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043

Made in USA

A180I0

Rev 10/2015

MallinckrodtTM 
Pharmaceuticals                                                                                                                                                

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:
Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043
Made in USA

MallinckrodtTM
Pharmaceuticals

CAUTION RADIOACTIVE MATERIAL

A180C0
R10/2015