JURNISTA TABLET (EXTENDED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

HYDROMORPHONE HYDROCHLORIDE

MAH:

JANSSEN INC

ATC_code:

N02AA03

INN:

HYDROMORPHONE

dosage:

32MG

pharmaceutical_form:

TABLET (EXTENDED-RELEASE)

composition:

HYDROMORPHONE HYDROCHLORIDE 32MG

administration_route:

ORAL

units_in_package:

30

prescription_type:

Narcotic (CDSA I)

therapeutic_area:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0108698013; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-10-31

SPC

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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.
_232334 APM.doc_
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_Page 2 of 52 _
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
.....