JURNISTA TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-12-2019
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Active ingredient:
HYDROMORPHONE HYDROCHLORIDE
Available from:
JANSSEN INC
ATC code:
N02AA03
INN (International Name):
HYDROMORPHONE
Dosage:
8MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
HYDROMORPHONE HYDROCHLORIDE 8MG
Administration route:
ORAL
Units in package:
7/10/30
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0108698005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-10-31
Summary of Product characteristics
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PRODUCT MONOGRAPH
N
JURNISTA
®
HYDROmorphone hydrochloride Prolonged Release Tablets
4, 8, 16, and 32 mg
Opioid Analgesic
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Distribution Site:
Markham, Ontario
L3R 0T5
Date of Preparation:
November 17, 2009
Date of Revision:
December 13, 2019
SUBMISSION CONTROL NO.: 232334
All trademarks used under license.
© 2019 Janssen Inc.
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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
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
22
OVERDOSAGE
.......................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 28
STORAGE AND STABILITY
.................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
.....
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