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Name:Gallium Citrate Ga-67
Manufacturer:Mallinckrodt Inc.
Category:Prescription Marketed Drugs


GALLIUM CITRATE GA-67 - gallium chloride ga-67 injection, solution 
Mallinckrodt Inc.

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Rx Only

Diagnostic – For Intravenous Use

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 hours1 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

1
Kocher, D.C., Radioactive Decay Data Tables, Health and Safety Research Division, National Technical Information Service, DOE/TIC-11026, pg. 80, 1981.

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 0.5
0.41 10-1
1.2 10-2
2.5 10-3
4.8 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

*Calibration Time

Hours Fraction Remaining Hours Fraction Remaining
0* 1.000 72 (3d) 0.529
6 0.948 78 0.501
12 0.899 84 0.475
18 0.853 90 0.451
24 (1d) 0.809 96 (4d) 0.427
30 0.767 108 0.384
36 0.727 120 (5d) 0.345
42 0.689 132 0.311
48 (2d) 0.654 144 (6d) 0.279
54 0.620 156 0.251
60 0.588 168 (7d) 0.226
66 0.557

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.

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.

CONTRAINDICATIONS

None.

WARNINGS

None known.

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 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 insure 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.

ADVERSE REACTIONS

Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga-67 use.

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 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 insure 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.

Radiation Dosimetry

The estimated absorbed radiation doses2 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

2
MIRD Dose Estimate Report No. 2, J. Nucl. Med. 14; 755-6 (1973).

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 0019-N180-G0
N180M0 444 megabecquerels (12 mCi)
NDC 0019-N180-M0

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 Inc.
St. Louis, MO 63134

tyco
Healthcare
MALLINCKRODT

Rev 112706
A180I0

PRINCIPAL DISPLAY PANEL - A180C0

GALLIUM CITRATE Ga 67 INJECTION

DIAGNOSTIC
Sterile, Non-Pyrogenic Solution
For Intravenous Administration
Store at Controlled Room Temperature 20-25°C (68-77°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.

In Canada:
Mallinckrodt Canada Inc.
Pointe-Claire, Qc
Est. Lic. No. 100107-A

Mallinckrodt Inc.
St. Louis, MO 63134 USA

MALLINCKRODT

CAUTION RADIOACTIVE MATERIAL

A180C0
R10/2000

PRINCIPAL DISPLAY PANEL - A180C0

GALLIUM CITRATE GA-67 
gallium citrate ga-67 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-N180
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALLIUM CHLORIDE GA-67 (GALLIUM CATION GA-67) GALLIUM CHLORIDE GA-67 2 mCi  in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE  
SODIUM CHLORIDE  
BENZYL ALCOHOL  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0019-N180-G0 1 VIAL ( VIAL) in 1 CAN contains a VIAL
1 3.3 mL in 1 VIAL This package is contained within the CAN (0019-N180-G0)
2 NDC:0019-N180-M0 1 VIAL ( VIAL) in 1 CAN contains a VIAL
2 6.6 mL in 1 VIAL This package is contained within the CAN (0019-N180-M0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018058 02/21/2008

Labeler - Mallinckrodt Inc. (047021092)
Establishment
Name Address ID/FEI Operations
Mallinckrodt Inc. 557570652 manufacture, analysis, api manufacture

Revised: 05/2011 Mallinckrodt Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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