Hexabrix 320

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Meglumine ioxaglate 39.3%{relative} (Gives 320mg iodine/ml); Sodium ioxaglate 19.65%{relative}

Available from:

Obex Medical Ltd

INN (International Name):

Meglumine ioxaglate 39.3% w/v (Gives 320mg iodine/ml)

Dosage:

320 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Meglumine ioxaglate 39.3%{relative} (Gives 320mg iodine/ml) Sodium ioxaglate 19.65%{relative} Excipient: Sodium calcium edetate, hydrate Water for injection

Units in package:

Bottle, 25 x 20ml, 500 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Guerbet

Therapeutic indications:

Low osmolar X-ray contrast medium for the opacification of the vascular system, urinary tract, joints and female genital tract. Hysterosalpingography

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 100ml - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, 20ml - 25 dose units - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, 50ml - 25 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1982-12-09

Summary of Product characteristics

1
DATA SHEET
HEXABRIX 320
_MEGLUMINE/SODIUM IOXAGLATE 320 MG IODINE/ML _
PRESENTATION
Hexabrix 320
Glass bottles containing a sterile solution of meglumine ioxaglate
39.30% w/v and
sodium ioxaglate 19.65% w/v containing 320 mg iodine in combined form
per ml. The
solution is a light yellow colour. The aqueous solution also contains
sodium calcium
ededate BP 0.01% w/v.
USES
_PHARMACOKINETICS _
Hexabrix 320 is rapidly eliminated by the kidneys with a half-life of
about 90 minutes.
99% of the dose is eliminated in 24 hours. Biliary excretion may be of
some importance
in kidney impairment. The compound is not metabolised.
_INDICATIONS _
This medicinal product is for diagnostic use only in adults and
children.
Low osmolar X-ray contrast medium for the opacification of the
vascular system, urinary
tract, joints and female genital tract, the indications for which are
given below.
DOSAGE AND ADMINISTRATION
For ease of injection it may be found helpful to warm Hexabrix 320 to
near body
temperature.
_FEMORAL AND OTHER PERIPHERAL ARTERIOGRAPHIES _
15-20 mL injected into the femoral or iliac artery will produce
excellent visualisation of
the arterial tree of the leg. A similar or smaller dose is indicated
for smaller arteries
.
_CEREBRAL ANGIOGRAPHY (CAROTID AND VERTEBRAL) _
Average adult dose 6 - 8 mL for each injection. Up to 10 injections
each of 8 mL may be
required.
2
_ANGIO-CARDIOGRAPHY _
Multiple small test injections may be used for positioning catheter
tip.
ADULTS AND CHILDREN OVER 14 YEARS
30-50 mL per injection.
CHILDREN (14 YEARS AND UNDER) AND INFANTS
1-1.5 mL per kg bodyweight.
Multiple injections may be required. Total dosage should not normally
exceed 4 mL per
kg bodyweight. In exceptional circumstances, this total dose may be
exceeded according
to the clinical condition.
_ABDOMINAL AORTOGRAPHY (DIRECT PUNCTURE OR CATHETERISATION) _
ADULTS
20-30 mL.
Up to 50 mL may be used particularly if films of the legs are also
taken following the
same injection.
_THORACIC AORTOGRAPHY (INCLUDING ARCH AORTOGRAPHY) _
ADULTS