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Renocal-76 (Diatrizoate Meglumine / Diatrizoate Sodium Intravascular) - Summary

 
 



NOT FOR INTRATHECAL USE

 

RENOCAL-76 SUMMARY

RenoCal-76®
Diatrizoate Meglumine and
Diatrizoate Sodium Injection USP

RenoCal-76 (Diatrizoate Meglumine and Diatrizoate Sodium Injection USP) is a radiopaque contrast agent for intravascular use supplied as a sterile, aqueous solution. Each mL provides 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium with 0.1 mg edetate calcium disodium as a sequestering agent. The pH has been adjusted to 6.0-7.7 with sodium carbonate and sodium hydroxide or hydrochloric acid. Each mL contains approximately 3.69 mg (0.16 mEq) sodium and 370 mg of organically bound iodine. The viscosity of the solution is 15 cps at 25°C and 9.1 cps at 37°C. It is hypertonic to blood with an osmolality of 1870 mOsm/kg. At the time of manufacture, the air in the container is replaced by nitrogen.

RenoCal-76 is indicated in excretion urography, nephrotomography, aortography, pediatric angiocardiography, peripheral arteriography, selective renal arteriography, selective visceral arteriography, selective coronary arteriography, selective coronary arteriography combined with left ventriculography, and intravenous digital subtraction angiography (DSA).

Computed Tomography

RenoCal-76 is also indicated for radiographic contrast enhancement in computed tomography (CT) of the brain. Contrast enhancement is advantageous in delineating or ruling out disease in suspicious areas which may otherwise not have been satisfactorily visualized.

Tumors

RenoCal-76 may be useful to demonstrate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas; ependymomas; medulloblastomas; meningiomas; neuromas; pinealomas; pituitary adenomas; craniopharyngiomas; germinomas; and metastatic lesions.

The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated.

In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.

Non-Neoplastic Conditions

The use of RenoCal-76 may be beneficial in the enhancement of images of lesions not due to neoplasms. Cerebral infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if a contrast medium is used. The use of RenoCal-76 improved the contrast enhancement in approximately 60 percent of cerebral infarctions studied from one week to four weeks from the onset of symptoms.

Sites of active infection also will produce contrast enhancement following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.

Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast medium administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

The opacification of the inferior vermis following contrast medium administration has resulted in false-positive diagnoses in a number of normal studies.


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Page last updated: 2016-04-29

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