XENETIX 350-50ML SOLN FOR INTRAVASCULAR INJ

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Iobitridol

Available from:

MEDI-DIAGNOSTIC SOLUTIONS (M) SDN. BHD.

INN (International Name):

Iobitridol

Units in package:

50ml mL

Manufactured by:

GUERBET

Summary of Product characteristics

244600 XENETIX
®
SOLUTION FOR INJECTION
PACKAGE INSERT
NAME OF THE MEDICINAL PRODUCT
XENETIX 300-50ML SOLN FOR INTRAVASCULAR, INTRAUTERINE AND
INTRA-ARTICULAR INJ
XENETIX 300-100ML SOLN FOR INTRAVASCULAR, INTRAUTERINE AND
INTRA-ARTICULAR INJ
XENETIX 350-50ML SOLN FOR INTRAVASCULAR INJ
XENETIX 350-100ML SOLN FOR INTRAVASCULAR INJ
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iobitridol
Excipient: sodium calcium edetate, trometamol, trometamol
hydrochloride,
sodium hydroxide or hydrochloric acid, water for injection.
EACH 100 ML OF XENETIX 300 SOLUTION CONTAINS:
Iobitridol
………………………………………………………………………65.81
g (658.1 mg/mL)
Corresponding mass of iodine
.……………………………………………….…30 g (300
mg/mL)
•
Iodine content per mL: 300 mg
•
Viscosity at 20°C: 11 mPa.s
•
Viscosity at 37°C: 6 mPa.s
•
Osmolality: 695 mOsm/kg H
2
O
•
Iodine quantity per 50 mL vial: 15 g
•
Iodine quantity per 100 mL vial: 30 g
EACH 100 ML OF XENETIX 350 SOLUTION CONTAINS:
Iobitridol
………………………………………………………….…………76.78
g (767.8 mg/mL)
corresponding mass of iodine
………………………………………………….35 g (350
mg/mL)
•
Iodine content per mL: 350 mg
•
Viscosity at 20°C: 21 mPa.s
•
Viscosity at 37°C: 10 mPa.s
•
Osmolality: 915 mOsm/kg H
2
O
•
Iodine quantity per 50 mL vial: 17.5 g
•
Iodine quantity per 100 mL vial: 35 g
Excipient with known effect: sodium (up to 3.5 mg per 100 mL).
For the full list of excipients, see Section _List of excipients_.
PHARMACEUTICAL FORM
Solution for Injection
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
244600
Xenetix® 300
Xenetix® 350
Contrast medium for use in:
-
Intravenous urography
-
Brain and whole body
computed tomography
-
Intravenous digital
subtraction angiography
-
Arteriography
-
Angiocardiography
-
Arthrography
-
Hysterosalpingography
-
Intravenous urography
-
Brain and whole body
co