Cysto-Conray II (Page 2 of 2)
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.
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
CYSTO-CONRAY II iothalamate meglumine injection | |||||||||||||||||
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Labeler — Liebel-Flarsheim Company LLC (057880002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LIEBEL-FLARSHEIM COMPANY LLC | 109024984 | ANALYSIS (0019-0862), MANUFACTURE (0019-0862) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Justesa Imagen, S.A.U. | 477020325 | API MANUFACTURE (0019-0862) |
Revised: 12/2020 Liebel-Flarsheim Company LLC
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