OPTIRAY 350 (ULTRAJECT) SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IOVERSOL

Tillgänglig från:

LIEBEL-FLARSHEIM COMPANY LLC

ATC-kod:

V08AB07

INN (International namn):

IOVERSOL

Dos:

74%

Läkemedelsform:

SOLUTION

Sammansättning:

IOVERSOL 74%

Administreringssätt:

INTRAVASCULAR

Enheter i paketet:

50/100/150ML

Receptbelagda typ:

Ethical

Terapiområde:

ROENTGENOGRAPHY

Produktsammanfattning:

Active ingredient group (AIG) number: 0131317001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2012-11-06

Produktens egenskaper

_ _
_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
.......