CONRAY 43 SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

IOTHALAMATE MEGLUMINE

제공처:

LIEBEL-FLARSHEIM CANADA INC

ATC 코드:

V08AA04

INN (국제 이름):

IOTALAMIC ACID

복용량:

430MG

약제 형태:

SOLUTION

구성:

IOTHALAMATE MEGLUMINE 430MG

관리 경로:

INTRAVASCULAR

패키지 단위:

50/100/200/250ML

처방전 유형:

Ethical

치료 영역:

ROENTGENOGRAPHY

제품 요약:

Active ingredient group (AIG) number: 0102763003; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2018-05-07

제품 특성 요약

_ _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CONRAY
®
30
(Iothalamate meglumine injection USP 30% w/v)
CONRAY
®
43
(Iothalamate meglumine injection USP 43% w/v)
CONRAY
®
60
(Iothalamate meglumine injection USP 60% w/v)
IONIC IODINATED RADIOGRAPHIC CONTRAST MEDIUM FOR INTRAVASCULAR USE
Liebel-Flarsheim Canada Inc.
7500 Trans-Canada Highway
Pointe-Claire, QC, H9R 5H8
CANADA
Date of Revision:
December 27,
2017
Submission Control No: 205718
_ _
_ _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL INFORMATION
..........................................................................29
DETAILED PHARMACOLOGY
.....................................................................................30
TOXICOLOGY
.