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Side Effects & Adverse Reactions
SEVERE ADVERSE EVENTS – INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to ensure that this drug product is not administered intrathecally.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
History
There is currently no drug history available for this drug.
Other Information
Cysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt) and has the following structural formula:
Each milliliter of Cysto-Conray II contains 172 mg of iothalamate meglumine, equivalent to 81 mg (8.1% w/v) of organically bound iodine, 0.110 mg edetate calcium disodium as a stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer.
Cysto-Conray II is hypertonic under conditions of use and is supplied in containers from which the air has been displaced by nitrogen. The pH of Cysto-Conray II is
6.6 to 7.6.
Sources
Cysto-conray Ii Manufacturers
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Mallinckrodt Inc.
Cysto-conray Ii | Mallinckrodt Inc.
Patient PreparationUnless contraindicated, an appropriate laxative is given the night before the examination.
Radiographic TechniqueThe radiographic procedure normally employed for cystography and cystourethrography should be employed. A preliminary radiograph is recommended before the contrast agent is administered.
AdministrationSterile catherization is essential. Cysto-Conray II may be introduced by gravity flow using an appropriate venoclysis set or by syringe. Excessive pressure should be avoided with any method of administration.
Usual DosageCystography and Cystourethrography – Either Conray 43 supplied at 43% w/v or Cysto-Conray II supplied at a 17.2% w/v concentration may be used for these procedures. The desired concentration will vary depending upon the patient’s size and age and also with the technique and equipment used. (SEE CONRAY 43 PACKAGE INSERT FOR SPECIFIC INFORMATION ABOUT THE USE OF THIS PRODUCT.) Sufficient volume of contrast medium is administered to adequately fill the urinary bladder. The volume of solution required will vary depending upon the individual patient. Adults usually require a volume in the range of 200 to 400 mL. Children require a volume in proportion to their body size. The usual dose ranges from 30 to 300 mL.
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