OPTIRAY 160 (ULTRAJECT) SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IOVERSOL

Saatavilla:

TYCO HEALTHCARE

ATC-koodi:

V08AB07

INN (Kansainvälinen yleisnimi):

IOVERSOL

Annos:

34%

Lääkemuoto:

SOLUTION

Koostumus:

IOVERSOL 34%

Antoreitti:

INTRAVASCULAR

Kpl paketissa:

100

Prescription tyyppi:

Ethical

Terapeuttinen alue:

ROENTGENOGRAPHY

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0131317004; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2010-03-12

Valmisteyhteenveto

PRESCRIBING INFORMATION
PROPRIETARY NAME:
OPTIRAY 160, 240, 300, 320, 350
PROPER NAME:
Ioversol Injection 34%, Ioversol Injection 51%,
Ioversol Injection 64%, Ioversol Injection 68%,
Ioversol Injection 74%
PHARMACOLOGY CLASSIFICATION:
Non-ionic,
low
osmolality,
water soluble,
radiopaque contrast medium for intravascular
use.
tyco Healthcare
7500 Trans Canada Highway
Montreal, Quebec H9R 5H8
CANADA
Revised: March 10, 2004
NC Control No: 087416
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PRODUCT MONOGRAPH
OPTIRAY
(Ioversol Injection)
OPTIRAY 160
(Ioversol Injection 34%, 160 mgI/mL)
OPTIRAY 240
(Ioversol Injection 51%, 240 mgI/mL)
OPTIRAY 300
(Ioversol Injection 64%, 300 mgI/mL)
OPTIRAY 320
(Ioversol Injection 68%, 320 mgI/mL)
OPTIRAY 350
(Ioversol Injection 74%, 350 mgI/mL)
THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION
Non-ionic, low osmolality, water soluble radiopaque
contrast medium for intravascular use.
Optiray 240 may be used in myelography.
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ACTIONS AND CLINICAL PHARMACOLOGY
A.
GENERAL
The pharmacokinetics of Optiray (ioversol) in normal subjects conform
to an open two
compartment model with first order elimination (a rapid alpha phase of
6.8 minutes for drug
distribution and a slower beta phase of 92 minutes, for drug
elimination). Based on the blood
clearance curves for 12 healthy volunteers (6 receiving 50 mL and 6
receiving 150 mL of
Optiray 320), the biological half-life was 1.5 hours for both dose
levels and there was no
evidence of any dose related difference in the rate of elimination.
The mean half-life for
urinary excretion following a 50 mL dose was 118 minutes (105-156) and
following a 150
mL dose was 105 minutes.
Optiray is excreted mainly through the kidneys following intravascular
administration. Fecal
elimination is 3-9%. Approximately 50% of the injected dose is
excreted at 1.5 hours and
86% at 48 hours; about 1.5% is retained, mostly by the thyroid and
liver. In patients with
impaired renal function and in infants with immature kidneys, the
elimination half-life is
prolonged. In patients with severe renal disease, ex