hypaque sodium- Diatrizoate Meglumine injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Diatrizoate Meglumine (UNII: 3X9MR4N98U) (diatrizoic acid - UNII:5UVC90J1LK)

MAH:

Amersham Health Inc.

INN:

Diatrizoate Meglumine

pharmaceutical_form:

INJECTION, SOLUTION

composition:

60 g in 100 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

HYPAQUE meglumine 60 percent is indicated for excretory urography; cerebral angiography; peripheral arteriography; venography; operative, T-tube, or percutaneous transhepatic cholangiography; splenoportography; arthrography; discography; and contrast enhancement of computed tomographic head imaging. Diatrizoate salts are used in small, medium, and large dose urography (see Dosage and Administration-EXCRETORY UROGRAPHY). Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures. Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction (see CLINICAL PHARMACOLOGY). Injectable radiopaque contrast media may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. Radiopaque diagnostic agents may be useful to investigate the presence and extent of certain malignancie

leaflet_short:

Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0746-04). Vials of 100 mL, rubber stoppered, box of 10 (NDC 0407-0747-02). Box of 10 calibrated 200 mL dilution bottles with hangers containing 150 mL HYPAQUE meglumine 60%; rubber stoppered (NDC 0407-0749-20). Box of 10 calibrated 200 mL dilution bottles with hangers containing 200 mL HYPAQUE meglumine 60%; rubber stoppered (NDC 0407-0750-10). Protect from light. Store at 15°C to 30°C (59° F to 86°F).

SPC

HYPAQUE SODIUM- DIATRIZOATE MEGLUMINE INJECTION, SOLUTION
AMERSHAM HEALTH INC.
----------
HYPAQUE MEGLUMINE
(DIATRIZOATE MEGLUMINE INJECTION, USP)
60%
Sterile Aqueous Injection
FOR EXCRETORY UROGRAPHY
CEREBRAL ANGIOGRAPHY
PERIPHERAL ARTERIOGRAPHY
VENOGRAPHY
DIRECT CHOLANGIOGRAPHY
SPLENOPORTOGRAPHY
ARTHROGRAPHY
DIS COGRAPHY
CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
NOT FOR INTRATHECAL USE
R ONLY
DESCRIPTION
HYPAQUE meglumine, brand of diatrizoate meglumine, is a water-soluble,
radiopaque diagnostic
medium. It is a triiodinated benzoic acid derivative containing 47.06
percent organically bound iodine. It
is constituted as an iodinated anion (diatrizoate) and a radiolucent
cation (meglumine).
HYPAQUE meglumine 60 percent (w/v) is a sterile aqueous solution
containing 60 g of the meglumine
salt of diatrizoic acid per 100 mL of solution. The solution is a
clear-colorless to pale yellow liquid,
and the pH is adjusted between 6.5 and 7.7 with diatrizoic acid or
meglumine solution. It is a relatively
thermostable solution and may be autoclaved without harmful effects,
although it should be protected
from strong light. The 60 percent solution contains edetate calcium
disodium 1:10,000 as a
sequestering stabilizing agent. Each 1 mL contains approximately 282
mg of organically bound iodine.
The viscosity of the solution is 6.17 cp at 25°C and 4.12 cp at
37°C.
It is hypertonic to blood with an osmolality of 1415 mosm/kg
(determined by VPO). A 13 percent
solution (w/v) is isotonic.
It is a colorless, microcrystalline solid which is readily soluble in
water.
It is meglumine 3,5-diacetamido-2,4,6-triiodobenzoate (C
H I N O • C H NO ) with a molecular
weight of 809.13, and has the following structural formula:
™
X
11
9 3
2
4
7
17
5
CLINICAL PHARMACOLOGY
Intravascular injection of a radiopaque diagnostic agent opacifies
those vessels in the path of the flow
of the contrast medium, permitting radiographic visualization of the
internal structures of the human
body until significant hemodilution occurs.
At phys