Product Information
Registration Status: ActiveSIN07748P
OPTIRAY 350 INJECTION 74% is approved to be sold in Singapore with effective from 1994-06-15. It is marketed by TRANSMEDIC PTE LTD, with the registration number of SIN07748P.
This product contains Ioversol 741mg/ml in the form of INJECTION. It is approved for INTRAVASCULAR use.
This product is manufactured by Mallinckrodt Inc in UNITED STATES, andMallinckrodt Canada ULC in CANADA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Ioversol is an organoiodine compound used as a diagnostic contrast medium. It features both a high iodine content, as well as several hydrophilic groups.
Indication
Optiray 350 is indicated in adults for peripheral and coronary arteriography and left ventriculography. Optiray 350 is also indicated for contrast enhanced computed tomographic imaging of the head and body, intravenous excretory urography, intravenous digital subtraction angiography and venography. Optiray 350 is indicated in children for angiocardiography. Optiray 320 is indicated in adults for angiography throughout the cardiovascular system. The uses include cerebral, coronary, peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography. Optiray 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. Optiray 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. Optiray 300 is indicated for cerebral angiography and peripheral arteriography. Optiray 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography. Optiray 240 is indicated for cerebral angiography and venography. Optiray 240 is also indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous excretory urography.
Mechanism of Action
Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Optiray enhances computed tomographic imaging through augmentation of radiographic efficiency with the degree of density enhancement directly related to the iodine content in an administered dose.
Pharmacokinetics
- Absorption
- Ioversol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring within 5 to 15 minutes.
- Distribution
- Metabolism
- No significant metabolism, deiodination or biotransformation occurs.
- Elimination
Toxicity
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. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered.
Active Ingredient/Synonyms
N,N'-Bis (2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl) -glycolamido] -2,4,6-triiodoisophthalamide | Optiray | Ioversol |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.