boxed warning
NOT FOR INTRAVASCULAR ADMINISTRATION NOT FOR INTRATHECAL USE
Cysto-Conray II
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Cysto-Conray II
- Generic name
- IOTHALAMATE MEGLUMINE
- Manufacturer
- Liebel-Flarsheim Company LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 8841ab4d-674d-4beb-88a5-13e35f6005cc
- SPL ID
- ff628e06-2cb5-4714-a741-1dec04bd5602
- Version
- 18
- Effective date
- 2020-12-31
- Source export date
- 2026-08-01
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:08:53
| Harmonized routes |
|---|
| URETERAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 017057 | derived:openfda.application_number |
| application number | NDA017057 | openfda.application_number | |
| brand name | Cysto-Conray II | openfda.brand_name | |
| generic name | IOTHALAMATE MEGLUMINE | openfda.generic_name | |
| manufacturer name | Liebel-Flarsheim Company LLC | openfda.manufacturer_name | |
| ndc | package | 0019-0862-50 | openfda.package_ndc |
| ndc | product | 0019-0862 | openfda.product_ndc |
| ndc11 | package | 00019086250 | derived:openfda.package_ndc |
| spl id | ff628e06-2cb5-4714-a741-1dec04bd5602 | id | |
| spl set id | 8841ab4d-674d-4beb-88a5-13e35f6005cc | set_id | |
| unii | XUW72GOP7W | openfda.unii |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
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.