OPTIRAY 300 (ULTRAJECT) SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

IOVERSOL

Mevcut itibaren:

LIEBEL-FLARSHEIM COMPANY LLC

ATC kodu:

V08AB07

INN (International Adı):

IOVERSOL

Doz:

64%

Farmasötik formu:

SOLUTION

Kompozisyon:

IOVERSOL 64%

Uygulama yolu:

INTRAVASCULAR

Paketteki üniteler:

30ML/50ML

Reçete türü:

Ethical

Terapötik alanı:

ROENTGENOGRAPHY

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2021-11-30

Ürün özellikleri

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_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
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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
.......