Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**4.2. Posology and method of administration** The doses must be adapted to the examination and the regions to be opacified, as well as to the body weight and renal function of the subject. There is no data about the use of Xenetix in pediatric patients. Therefore, the use of Xenetix is not recommended in pediatric patients. Usually the same iodine concentration and volume are used as with other iodinated X-ray contrast in current use. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. Adequate hydration should be assured before and after administration as for other contrast media. Usually, the rate of administration varies between 0.5 and 5 ml/s depending on the type of examination. **Xenetix® 300** **Recommended mean dosages for intravascular routes:**  **Xenetix® 300** **Recommended mean dosages for intracavitary routes:**  **Xenetix® 350** **Recommended mean dosages for intravascular routes:** 
INTRAVASCULAR
Medical Information
**4.1. Therapeutic indications** This medicinal product is for diagnostic use only. Contrast agent for use in: 
**4.3. Contraindication** - Hypersensitivity to iobitridol or any of the excipients. - History of a major immediate reaction or delayed skin reaction to a Xenetix® injection. - Manifest thyrotoxicosis - In the absence of specific studies, myelography is not an indication for Xenetix®. - Hysterosalpingography during pregnancy is contraindicated for Xenetix® 300.
V08AB11
iobitridol
Manufacturer Information
TRANSMEDIC PTE LTD
GUERBET
Active Ingredients
Documents
Package Inserts
Xenetix Injection PI.pdf
Approved: August 19, 2019