Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
TOLVAPTAN; TOLVAPTAN
OTSUKA PHARMACEUTICAL CO LTD
C03XA01
TOLVAPTAN
15MG; 15MG
TABLET
TOLVAPTAN 15MG; TOLVAPTAN 15MG
ORAL
15G/50G
Prescription
VASOPRESSIN ANTAGONISTS
Active ingredient group (AIG) number: 0256610004; AHFS:
APPROVED
2019-08-16
_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 ........ Aqra d-dokument sħiħ