JINARC TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TOLVAPTAN; TOLVAPTAN

제공처:

OTSUKA PHARMACEUTICAL CO LTD

ATC 코드:

C03XA01

INN (국제 이름):

TOLVAPTAN

복용량:

90MG; 30MG

약제 형태:

TABLET

구성:

TOLVAPTAN 90MG; TOLVAPTAN 30MG

관리 경로:

ORAL

패키지 단위:

7/14/30

처방전 유형:

Prescription

치료 영역:

VASOPRESSIN ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0256610001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-02-16

제품 특성 요약

_JINARC_
®
_ Product Monograph _
_Page 1 of 43_
PRODUCT MONOGRAPH
Pr
JINARC
®
(tolvaptan)
Tablets, 15 mg, 30 mg, 45 mg, 60 mg and 90 mg
Vasopressin V
2
-receptor Antagonist
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan 101-8535
Imported and distributed by
Otsuka Canada Pharmaceutical Inc.
Saint-Laurent, Quebec
H4S 2C9
Date of Preparation:
February 23, 2015
Date of Revision:
October 23, 2019
Submission Control No: 228294
_ _
_JINARC_
®
_ Product Monograph _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
.........................................................................
26
CLINICAL TRIALS
........