Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Meglumine ioxaglate 39.3%{relative} (Gives 320mg iodine/ml); Sodium ioxaglate 19.65%{relative}
Obex Medical Ltd
Meglumine ioxaglate 39.3% w/v (Gives 320mg iodine/ml)
320 mg/mL
Solution for injection
Active: Meglumine ioxaglate 39.3%{relative} (Gives 320mg iodine/ml) Sodium ioxaglate 19.65%{relative} Excipient: Sodium calcium edetate, hydrate Water for injection
Bottle, 25 x 20ml, 500 mL
General sale
General sale
Guerbet
Low osmolar X-ray contrast medium for the opacification of the vascular system, urinary tract, joints and female genital tract. Hysterosalpingography
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
1982-12-09
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 Lugege kogu dokumenti