OPTIRAY 240 (ULTRAJECT) SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IOVERSOL

Available from:

LIEBEL-FLARSHEIM COMPANY LLC

ATC code:

V08AB07

INN (International Name):

IOVERSOL

Dosage:

51%

Pharmaceutical form:

SOLUTION

Composition:

IOVERSOL 51%

Administration route:

SUBARACHNOIDAL

Units in package:

50ML/125ML

Prescription type:

Ethical

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0131317002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-01-12

Summary of Product characteristics

_ _
_Page 1 of 55_
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
_ _
_ _
_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
.......