[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.563]

[Page 232]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.563  Diatrizoate meglumine and diatrizoate sodium injection.

    (a) Specifications. Diatrizoate meglumine and diatrizoate sodium 
injection contains 34.3 percent diatrizoate meglumine and 35 percent 
diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent 
diatrizoate sodium, in sterile aqueous solution.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for use in dogs and cats 
for visualization in excretion urography, including renal angiography, 
uretography, cystography, and urethrography; aortography; 
angiocardiography, peripheral arteriography, and venography; selective 
coronary arteriography; cerebral angiography; lymphography; 
arthrography; discography; and sialography. It is also useful as an aid 
in delineating peritoneal hernias and fistulous tracts.
    (2) For excretion urography administer 0.5 to 1.0 milliliter per 
pound of body weight to a maximum of 30 milliliters intravenously. For 
cystography remove urine, administer 5 to 25 milliliters directly into 
the bladder via catheter. For urethrography administer 1.0 to 5 
milliliters via catheter into the urethra to provide desired contrasts 
delineation. For angiocardiography (including aortography) rapidly 
inject 5 to 10 milliliters directly into the heart via catheter or 
intraventricular puncture. For cerebral angiography rapid injection of 3 
to 10 milliliters via carotid artery. For peripheral arteriography and/
or venography and selective coronary arteriography rapidly inject 3 to 
10 milliliters intravascularly into the vascular bed to be delineated. 
For lymphography slowly inject 1.0 to 10 milliliters directly into the 
lymph vessel to be delineated. For arthrography slowly inject 1.0 to 5 
milliliters directly into the joint to be delineated. For discography 
slowly inject 0.5 to 1.0 milliliter directly into the disc to be 
delineated. For sialography slowly inject 0.5 to 1.0 milliliter into the 
duct to be delineated. For delineation of fistulous tracts slowly inject 
quantity necessary to fill the tract. For delineation of peritoneal 
hernias inject 0.5 to 1.0 milliliter per pound of body weight directly 
into the peritoneal cavity.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985]