JINARC TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
23-10-2019
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Aktiva substanser:
TOLVAPTAN; TOLVAPTAN
Tillgänglig från:
OTSUKA PHARMACEUTICAL CO LTD
ATC-kod:
C03XA01
INN (International namn):
TOLVAPTAN
Dos:
15MG; 15MG
Läkemedelsform:
TABLET
Sammansättning:
TOLVAPTAN 15MG; TOLVAPTAN 15MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
VASOPRESSIN ANTAGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0256610004; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2019-08-16
Produktens egenskaper
_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
........
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