OSMOVIST 240 - LIQ INT 513MG/ML SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

IODINE (IOTROLAN)

Mevcut itibaren:

BAYER INC

ATC kodu:

V08AB06

INN (International Adı):

IOTROLAN

Doz:

240MG

Farmasötik formu:

SOLUTION

Kompozisyon:

IODINE (IOTROLAN) 240MG

Uygulama yolu:

INTRATHECAL

Paketteki üniteler:

10ML

Reçete türü:

Ethical

Terapötik alanı:

ROENTGENOGRAPHY

Ürün özeti:

Active ingredient group (AIG) number: 0103970024; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2009-08-06

Ürün özellikleri

PRODUCT MONOGRAPH
OSMOVIST
®
Iotrolan Injection
OSMOVIST
® 240
Iotrolan Injection 240 mg I/mL
OSMOVIST
® 300
Iotrolan Injection 300 mg I/mL
Dimeric Non-ionic Radiographic Contrast Medium
For Myelography
Bayer Inc.
Date of Preparation:
77 Belfield Road
April 11, 2007
Toronto, Ontario
M9W 1G6
Canada
www.bayer.ca
Submission Control No.:
113334
© 2007, Bayer Inc.
Page
2
PRODUCT MONOGRAPH
OSMOVIST
®
Iotrolan injection
OSMOVIST
® 240
Iotrolan injection 240 mg I/mL
OSMOVIST
® 300
Iotrolan injection 300 mg I/mL
THERAPEUTIC CLASSIFICATION
A Dimeric Non-ionic Radiographic Contrast Medium For Myelography
ACTION AND CLINICAL PHARMACOLOGY
OSMOVIST (iotrolan) is a dimeric, non-ionic, hexaiodinated
radiocontrast medium. The
contrast-giving substance, iotrolan, is a dimer of triiodinated
isophthalic acid derivatives,
in which the firmly bound iodine absorbs the X-rays. Solutions of
OSMOVIST 240 mg
I/mL and 300 mg I/mL are isotonic to plasma and cerebrospinal fluid at
radiologically
useful iodine levels.
After intrathecal administration, iotrolan is absorbed from
cerebrospinal fluid (CSF) into
the blood stream. The mean half-life of the transfer of iotrolan from
the spinal fluid to
the blood plasma was found to be 5.7 ± 6.0 hours in adults. The
highest concentration
of iodine in plasma occurred 3.5 ± 3.1 hours after intrathecal
administration. Plasma
protein binding at a concentration of 1.2 mg I/mL is 2.4%. The mean
elimination half-
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3
life of iotrolan in the plasma is 13.6 ± 13.9 hours (median of 9
hours). Approximately 50-
80% of the administered dose is excreted unmetabolized by the kidneys
within 24 hours
after administration, and approximately 90% within 72 hours. Only 0.6%
of the dose
was found in the feces collected up to 72 hours after dosing.
Total and renal clearance following intravenous injection is 93.5 ± 5
mL/min and 90 ± 4
mL/min, respectively.
In patients with renal impairment, depending on the degree of
impairment, decreased
renal elimination may cause prolonged iotrolan levels in plasma.
After