Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Cysto-Conray ® II Glass Bottles NDC Number 12 x 250 mL single dose bottles 0019-0862-50 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. This product is sensitive to light and must be protected from strong daylight or direct exposure to the sun. As with all contrast media, the containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 0862A0817 Revised 08/17 Guerbet; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Cysto-Conray™ll Label Not For Intravascular Administration Sterile Solution Cysto-Conray ® ll 250 mL NDC 0019-0862-50 Iothalamate Meglumine Injection USP 17.2% 81 mg/mL Organically Bound Iodine For Retrograde Cystography and Cystourethrography NOT FOR INTRATHECAL USE Rx Only Protect from light • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each mL contains 172 mg iothalamate meglumine, 0.110 mg edetate calcium disodium as a stabilizer, and 0.115 mg monobasic sodium phosphate as a buffer. Single dose container • Discard unused portion Usual Dosage: See Package Insert. 10230419 Guerbet Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA Principal Display Panel
- HOW SUPPLIED Cysto-Conray ® II Glass Bottles NDC Number 12 x 250 mL single dose bottles 0019-0862-50 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. This product is sensitive to light and must be protected from strong daylight or direct exposure to the sun. As with all contrast media, the containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 0862A0817 Revised 08/17 Guerbet
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Cysto-Conray™ll Label Not For Intravascular Administration Sterile Solution Cysto-Conray ® ll 250 mL NDC 0019-0862-50 Iothalamate Meglumine Injection USP 17.2% 81 mg/mL Organically Bound Iodine For Retrograde Cystography and Cystourethrography NOT FOR INTRATHECAL USE Rx Only Protect from light • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each mL contains 172 mg iothalamate meglumine, 0.110 mg edetate calcium disodium as a stabilizer, and 0.115 mg monobasic sodium phosphate as a buffer. Single dose container • Discard unused portion Usual Dosage: See Package Insert. 10230419 Guerbet Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA Principal Display Panel
Overview
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. chemical structure
Indications & Usage
Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
Dosage & Administration
Patient Preparation Unless contraindicated, an appropriate laxative is given the night before the examination. Radiographic Technique The radiographic procedure normally employed for cystography and cystourethrography should be employed. A preliminary radiograph is recommended before the contrast agent is administered. Administration Sterile 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 Dosage Cystography 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.
Warnings & Precautions
WARNINGS 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.
Boxed Warning
NOT FOR INTRAVASCULAR ADMINISTRATION NOT FOR INTRATHECAL USE
Contraindications
See WARNINGS concerning inadvertant intrathecal administration.
Adverse Reactions
Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur. As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest. Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection. In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.
Storage & Handling
Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. This product is sensitive to light and must be protected from strong daylight or direct exposure to the sun. As with all contrast media, the containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 0862A0817 Revised 08/17 Guerbet
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