XENETIX Solution for injection Ref.[8834] Active ingredients: Iobitriol

Revision Year: 2014  Publisher: GUERBET, BP 57400 F-95943 Roissy CDG Cedex, France Manufacturing site address: GUERBET, 16-24 rue Jean Chaptal, 93600 Aulnay-sous-Bois, France

Therapeutic indications

This medicinal product is for diagnostic use only.

Contrast agent for use in:

Xenetix 250Xenetix 300Xenetix 350
Intravenous digital subtraction angiographyIntravenous urography, Intravenous digital subtraction angiography, Arthrography, HysterosalpingographyIntravenous urography, Intravenous digital subtraction angiography

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 250 – Recommended mean dosages for intravascular routes:

IndicationsMean dose (ml/kg)Total volume range (ml)
Intravenous digital subtraction angiography3.175-360

Xenetix 300 – Recommended mean dosages for intravascular routes:

IndicationsMean dose (ml/kg)Total volume range (ml)
Urography with:
rapid i.v. injection1.250-100
slow i.v. injection1.6100
Intravenous digital subtraction angiography1.740-270

Xenetix 300 – Recommended mean dosages for intracavitary routes:

IndicationsMean volume (ml)Comments
Arthrography5 to 20Intraarticular route Volume adapted to the joint
Hysterosalpingography5 to 20Intrauterine route Dose to be adapted to the uterine volume

Xenetix 350 – Recommended mean dosages for intravascular routes:

IndicationsMean dose (ml/kg)Total volume range (ml)
Intravenous urography1.050-100
Intravenous digital subtraction angiography2.195-250

Overdose

If a very high dose of contrast agent is administered, the water and electrolyte loss must be compensated by suitable rehydration. Renal function must be monitored for at least three days. Haemodialysis may be performed if necessary.

Shelf life

Three years.

Special precautions for storage

Keep out of the reach and sight of children.

Vials/bottles: Do not store above 30°C and protect from light.

Do not use after the expiry date given on the vial.

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