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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.563]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.563 Diatrizoate.

(a) Specifications. Each milliliter of solution contains 34.3 percent diatrizoate meglumine and 35 percent diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats - (1) Amount. For excretion urography, administer 0.5 to 1.0 milliliter (mL) per pound of body weight to a maximum of 30 mL intravenously. For cystography, remove urine, administer 5 to 25 mL directly into the bladder via catheter. For urethrography, administer 1.0 to 5 mL via catheter into the urethra to provide desired contrasts delineation. For angiocardiography (including aortography) rapidly inject 5 to 10 mL directly into the heart via catheter or intraventricular puncture. For cerebral angiography, rapid injection of 3 to 10 mL via carotid artery. For peripheral arteriography and/or venography and selective coronary arteriography, rapidly inject 3 to 10 mL intravascularly into the vascular bed to be delineated. For lymphography, slowly inject 1.0 to 10 mL directly into the lymph vessel to be delineated. For arthrography, slowly inject 1.0 to 5 mL directly into the joint to be delineated. For discography, slowly inject 0.5 to 1.0 mL directly into the disc to be delineated. For sialography, slowly inject 0.5 to 1.0 mL 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 mL per pound of body weight directly into the peritoneal cavity.

(2) Indications for use. 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; and as an aid in delineating peritoneal hernias and fistulous tracts.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16186, Mar. 25, 2014]

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