Rx Item-Sinografin 26.8 52.7% Vial 10X10Ml By Bracco Diagnostics

SINOGRAFIN- diatrizoate meglumine and iodipamide meglumine injection, solution
BRACCO DIAGNOSTICS INC
DESCRIPTION

Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is a sterile, nonpyrogenic, essentially colorless to pale yellow, aqueous radiopaque contrast medium for intrauterine instillation. Each mL provides 527 mg diatrizoate meglumine and 268 mg iodipamide meglumine with 3.2 mg sodium citrate as a buffer, and 0.4 mg edetate disodium; pH has been adjusted to 7.0 to 7.8 with meglumine and diatrizoic acid. Each mL contains approximately 0.91 mg (0.04 mEq) sodium and 380 mg organically bound iodine. At the time of manufacture, the air in the container is replaced with nitrogen.

Diatrizoate meglumine is designated chemically as 1-deoxy-1-( methylamino)-D-glucitoI 3,5-diacetamido-2,4,6- triiodobenzoate (salt); iodipamide meglumine is 1-deoxy-1- (methylamino)-D-glucitoI 3,3�-(adipoyldiimino)bis[2,4,6- triiodobenzoate] (2:1) (salt).
CLINICAL PHARMACOLOGY

The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast of the uterus and uterine tubes with surrounding tissues.

Diagnostic intrauterine radiopaque agents have few known pharmacological effects. Most of the medium within the uterine cavity is discharged immediately upon termination of the procedure. Any medium retained in the uterine cavity is completely absorbed within one hour, unless there is an obstruction and large hydrosalpinx, in which case absorption is generally complete within 24 hours. Any medium spilled into the peritoneal cavity is absorbed within 20 to 60 minutes and excreted by both the hepatic and renal systems.
INDICATIONS AND USAGE

Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is indicated for use in hysterosalpingography.
Information for the Patient

Patients receiving diagnostic agents for intrauterine radiography should be given the following information:

This drug has been prescribed to perform an X-ray study of the uterus and uterine tubes.
Patients should be questioned regarding a recent history (within 30 days) of curettage or conization, pregnancy or a recent history (within six months) of termination of pregnancy, and a history of allergy to iodine, any foods, or X-ray dyes.
Patients should consult the physician if, at some future date, any thyroid tests are planned. The iodine in this agent may interfere with some thyroid tests.
This drug may cause adverse reactions (see ADVERSE REACTIONS) in some patients but most reactions are mild and pass quickly.

RX ITEM-Sinografin 26.8 52.7% Vial 10X10
NDC 00270-0523-30 UPC/GTIN No.3-02700-52330-9 Mfg.Part No.52330

Sinografin 26.8 52.7% Vial 10X10Ml By Br
BRAND: SINOGRAFIN NDC: 00270-0523-30,270052330 UPC: 3-02700-52330-9,302700523309 Bracco Diagnostics, Inc.

IODIPAMIDE MEG/DIATR MEGL
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