Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**4.2 POSOLOGY AND METHOD OF ADMINISTRATION** The dosage varies depending on the type of examination, age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use. Adequate hydration should be assured before and after administration as for other contrast media. For intravenous, intra-arterial and intrathecal use, and use in body cavities. The following dosages may serve as a guide. **Guidelines for intravenous use**  **Guidelines for intra-arterial use**  **Guidelines for intrathecal use**  To minimize possible adverse reactions a total dose of 3 g iodine should not be exceeded. **Guidelines for Body cavities** 
INTRAVASCULAR
Medical Information
**4.1 THERAPEUTIC INDICATIONS** This medicinal product is for diagnostic use only. X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT-enhancement. Lumbar, thoracic, cervical myelography and computed tomography of the basal cisterns, following subarachnoid injection. Arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography and studies of the gastrointestinal tract.
**4.3 CONTRAINDICATIONS** Hypersensitivity to the active substance or to any of the excipients (See Section **6.1 LIST OF EXCIPIENTS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Manifest thyrotoxicosis.
V08AB02
iohexol
Manufacturer Information
GE HEALTHCARE PTE. LTD.
GE HEALTHCARE IRELAND LIMITED (by Parametric Release)
GE HEALTHCARE AS (by Parametric Release)
GE HEALTHCARE (SHANGHAI) CO., LTD
Active Ingredients
Documents
Package Inserts
Omnipaque Injection PI.pdf
Approved: April 21, 2023