RENO-60 LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIATRIZOATE MEGLUMINE

Available from:

BRACCO IMAGING CANADA

ATC code:

V08AA01

INN (International Name):

DIATRIZOIC ACID

Dosage:

600MG

Pharmaceutical form:

LIQUID

Composition:

DIATRIZOATE MEGLUMINE 600MG

Administration route:

INTRAVENOUS

Units in package:

50/100/150 ML

Prescription type:

Ethical

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0101809002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-01-05

Summary of Product characteristics

RENO-60 - DIATRIZOATE MEGLUMINE INJECTION, SOLUTION
Bracco Diagnostics Inc
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NOT FOR INTRATHECAL USE
DESCRIPTION
Reno-60 is a radiopaque contrast agent supplied as a sterile, aqueous
solution for
parenteral use. Each mL provides 600 mg diatrizoate meglumine; at
manufacture,
3.2 mg sodium citrate buffer and 0.4 mg edetate disodium sequestering
agent
are added per mL. The pH has been adjusted between 6.0 and 7.7 with
meglumine and diatrizoic acid.Each mL of solution also contains
approximately
0.91 mg (0.04 mEq) sodium and 282 mg organically bound iodine. At the
time of
manufacture, the air in the container is replaced by nitrogen.
CLINICAL PHARMACOLOGY
Following intravascular injection, Reno-60 is rapidly transported
through the
bloodstream to the kidneys and is excreted unchanged in the urine by
glomerular
filtration. When urinary tract obstruction is severe enough to block
glomerular
filtration, the agent appears to be excreted by the tubular
epithelium.
Certain applications of the contrast agent make use of the natural
physiologic
mechanism of excretion. Thus the intravenous injection of the agent
permits
visualization of the kidneys and urinary passages.
Renal accumulation is sufficiently rapid that the period of maximal
opacification
of the renal passages may begin as early as five minutes after
injection. In infants
and small children excretion takes place somewhat more promptly than
in adults,
so that maximal opacification occurs more rapidly and is less
sustained. The
normal kidney eliminates the contrast medium almost immediately. In
nephropathic conditions, particularly when excretory capacity has been
altered,
the rate of excretion varies unpredictably, and opacification may be
delayed for
30 minutes or more after injection; with severe impairment
opacification may not
occur. Generally, however, the medium is concentrated in sufficient
amounts and
promptly enough to permit a thorough evaluation of the anatomy and
physiology
of the urinary tract. After intramuscular injection, the contra