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

Principal Display Panel
(click image for full-size original)
CYSTO-CONRAY II
iothalamate meglumine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-0862
Route of Administration URETERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IOTHALAMATE MEGLUMINE (IOTHALAMIC ACID) IOTHALAMATE MEGLUMINE 172 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE CALCIUM DISODIUM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0019-0862-50 12 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 250 mL in 1 BOTTLE, GLASS This package is contained within the BOX (0019-0862-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017057 10/08/2010
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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