Document
DailyMed Label: Optiray
Title
DailyMed Label: Optiray
Date
2023
Document type
DailyMed Prescription
Name
Optiray
Generic name
Ioversol
Manufacturer
Liebel-Flarsheim Company LLC
Product information
NDC: 0019-1333
Product information
NDC: 0019-1323
Product information
NDC: 0019-1332
Product information
NDC: 0019-1333
Product information
NDC: 0019-1323
Product information
NDC: 0019-1332
Product information
NDC: 0019-1333
Product information
NDC: 0019-1323
Product information
NDC: 0019-1332
Product information
NDC: 0019-1333
Product information
NDC: 0019-1323
Product information
NDC: 0019-1332
Product information
NDC: 0019-1333
Product information
NDC: 0019-1333
Product information
NDC: 0019-1323
Product information
NDC: 0019-1323
Product information
NDC: 0019-1332
Product information
NDC: 0019-1332
Indications
OPTIRAY is indicated for:
Dosage forms
Injection: clear, colorless to pale yellow solutions containing no undissolved solids, available in the following strengths and multiple-dose containers:
Imaging Product
mg of ioversol per mL
mg of organically bound iodine per mL
Imaging Bulk Pack Presentation
OPTIRAY 300 (Ioversol 64%)
636
300
Yes
OPTIRAY 320 (Ioversol 68%)
678
320
Yes
OPTIRAY 350 (Ioversol 74%)
741
350
Yes
Contraindications
Symptomatic hyperthyroidism.
Adverse reactions
The following clinically significant adverse reactions are described elsewhere in the labeling:
Package label
Multiple-Dose Container Sterile Solution NDC 0019-1332-65
Optiray ® Imaging Bulk Package - 300
Ioversol Injection 64%
300 mg/mL Organically Bound Iodine
For Intravenous and Intra-arterial Use Only
Rx only
Imaging Bulk Package - Not for Direct Infusion
Not For Intrathecal Use
For use only with an automated contrast media transfer set, automated contrast injection system, or contrast management system cleared for use with this Imaging Bulk Package. See device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.
Protect from light • Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard contents if product is frozen or if crystallization occurs.
Each mL contains 636 mg ioversol, 3.6 mg tromethamine as a buffer and 0.2 mg edetate calcium disodium as a stabilizer.
The pH is adjusted with hydrochloric acid or sodium hydroxide.
Net Quantity: 6 X 500 mL Bottles
Recommended Dosage: See prescribing information
The Imaging Bulk Package container closure can only be penetrated one time. Discard the container no later than 12 hours after initial entry.
Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA
1 organization
1 product
Product
OptirayOrganization
Liebel-Flarsheim Company LLC