XENETIX 350 INJECTION 350 mgiml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IOBITRIDOL

Available from:

TRANSMEDIC PTE LTD

ATC code:

V08AB11

Pharmaceutical form:

INJECTION

Composition:

IOBITRIDOL 76.78g

Administration route:

INTRAVASCULAR

Prescription type:

Prescription Only

Manufactured by:

GUERBET

Authorization status:

ACTIVE

Authorization date:

1996-08-22

Summary of Product characteristics

Page 1 of 11
IS1100SG04
Package leaflet
Xenetix®, solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
XENETIX®, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xenetix® 300 (300mg iodine/ ml)
Per 100ml of solution:
Iobitridol …………………. 65.81g (658.1mg/ml)
Corresponding mass of iodine … 30g (300mg/ml)
Viscosity at 20°C: 11mPa.s
Viscosity at 37°C: 6mPa.s
Osmolality: 695mOsm/kg H
2
O
Xenetix® 350 (350mg iodine/ ml)
Per 100ml of solution:
Iobitridol ……………….… 76.78g (767.8mg/ml)
Corresponding mass of iodine … 35g (350mg/ml)
Viscosity at 20°C: 21mPa.s
Viscosity at 37°C: 10mPa.s
Osmolality: 915mOsm/kg H
2
O
Excipient with known effect: sodium (up to 3.5 mg per 100 mL).
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1. Therapeutic indications
This medicinal product is for diagnostic use only.
Contrast agent for use in:
Xenetix® 300
Xenetix® 350
-
Intravenous urography
-
Intravenous digital
subtraction angiography
-
Arthrography
-
Hysterosalpingography
-
Intravenous urography
-
Intravenous digital
subtraction angiography
Page 2 of 11
IS1100SG04
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:
Indications
Mean dose
(ml/kg)
Total volume range
(m