Visipaque

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Iodixanol 652 mg/mL equivalent to 320 mg/mL Iodine

Available from:

GE Healthcare Limited

INN (International Name):

Iodixanol 652 mg/mL (=320 mg/mL Iodine)

Dosage:

320 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Iodixanol 652 mg/mL equivalent to 320 mg/mL Iodine Excipient: Calcium chloride dihydrate Hydrochloric acid Sodium calcium edetate Sodium chloride Trometamol Water for injection

Units in package:

Bag, plastic, 100, 150 & 200 mL,

Class:

General sale

Prescription type:

General sale

Manufactured by:

GE Healthcare AS

Therapeutic indications:

This medicine is for diagnostic use only. Visipaque is indicated, in adult patients, for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT-enhancement and studies of the upper gastrointestinal tract.

Product summary:

Package - Contents - Shelf Life: Bag, plastic, - 100 mL - 18 months from date of manufacture stored at or below 30°C - Bag, plastic, - 150 mL - 18 months from date of manufacture stored at or below 30°C - Bag, plastic, - 200 mL - 18 months from date of manufacture stored at or below 30°C - Bottle, glass, - 50 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, - 200 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, - 500 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, 200mL - 6 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Bottle, plastic, 500mL - 6 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Bottle, plastic, 200mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Bottle, plastic, 150mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Bottle, plastic, 100mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Bottle, plastic, 75mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Bottle, plastic, 50mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C 4 weeks unopened stored prior to use when stored at 37°C - Vial, glass, - 20 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1995-03-09

Summary of Product characteristics

1
1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
VISIPAQUE™
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
lodixanol Injection 270 mg I/ml, 320 mg I/ml
3 PHARMACEUTICAL FORM
VISIPAQUE injectable solution is provided as a ready-to-use sterile,
pyrogen-free, colourless to
pale yellow solution, in concentrations of 270 and 320 mg of
organically bound iodine per ml
(550 and 652 mg of iodixanol per ml, respectively). All solutions of
iodixanol are hypotonic to
blood. Sodium chloride and calcium chloride have been added resulting
in an isotonic solution
for injection. VISIPAQUE (270 mg I/ml) contains 0.07 mg calcium
chloride dihydrate per ml and
1.87 mg sodium chloride per ml, and VISIPAQUE (320 mg I/ml) contains
0.04 mg calcium
chloride dihydrate per ml and 1.10 mg sodium chloride per ml providing
for both concentrations
a
sodium/calcium
ratio
equivalent
to
blood.
In
addition,
each
millilitre
contains
1.2
mg
trometamol and 0.1 mg sodium calcium edetate; the pH is adjusted
between 6.8 and 7.7 with
hydrochloric acid and/or sodium hydroxide at 22ºC. All solutions are
terminally sterilised by
autoclaving and contain no preservatives.
PHYSICAL PROPERTIES OF VISIPAQUE
The two concentrations of VISIPAQUE, 270 mg I/ml and 320 mg I/ml have
the following physical
properties:
Parameter
Concentration (mg I/ml)
270
320
Osmolality (mOsm/kg water)
(vapour pressure at 37ºC)
290
290
Viscosity (mPa-s) at 20ºC
at 37ºC
11.3
5.8
25.4
11.4
Density (g/ml) at 20°C
1.369
1.356
At 37°C
1.314
1.303
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
VISIPAQUE is indicated, in adult patients, for angiocardiography,
peripheral arteriography,
visceral arteriography, cerebral arteriography, contrast-enhanced
computed tomography of the
head and body, excretory urography and venography. In arteriography,
VISIPAQUE may be
used for both conventional radiography and digital subtraction
angiography (DSA).
In children, VISIPAQUE is indicated for cardioangiography, urography,
CT-enhancement and
studies of the u