XENETIX 300 INJECTION 300 MGI/ML [SIN08866P]

Product Info

XENETIX 300 INJECTION 300 MGI/ML

[SIN08866P]

4.1. Therapeutic indications

This medicinal product is for diagnostic use only.
Contrast agent for use in:

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:

4.3. Contraindication

• Hypersensitivity to iobitridol or any of the excipients.

• History of a major immediate reaction or delayed skin reaction (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) 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.