OPTIRAY 320 (ULTRAJECT) SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IOVERSOL

Saatavilla:

LIEBEL-FLARSHEIM COMPANY LLC

ATC-koodi:

V08AB07

INN (Kansainvälinen yleisnimi):

IOVERSOL

Annos:

68%

Lääkemuoto:

SOLUTION

Koostumus:

IOVERSOL 68%

Antoreitti:

INTRAVASCULAR

Kpl paketissa:

50ML/75ML/100ML/125ML

Prescription tyyppi:

Ethical

Terapeuttinen alue:

ROENTGENOGRAPHY

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0131317003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2012-11-06

Valmisteyhteenveto

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
OPTIRAY
®
Ioversol Injection
Solution
OPTIRAY
® 240
Ioversol Injection 51% w/v, 240 mgI/mL
OPTIRAY
® 300
Ioversol Injection 64% w/v, 300 mgI/mL
OPTIRAY
® 320
Ioversol Injection 68% w/v, 320 mgI/mL
OPTIRAY
® 350
Ioversol Injection 74% w/v, 350 mgI/mL
Nonionic Iodinated Radiographic Contrast Medium
Intravascular, Subarachnoidal
Liebel-Flarsheim Company LLC
8800 Durant Road
Raleigh, North Carolina
27616 USA
Importer:
Liebel-Flarsheim Canada Inc.
7500 Trans-Canada Highway
Pointe-Claire, Quebec, H9R 5H8
Canada
Date of Revision:
November 26, 2021
Submission Control No: 255548
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_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................33
STORAGE AND STABILITY
..........................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
.......