JURNISTA TABLET (EXTENDED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

HYDROMORPHONE HYDROCHLORIDE

זמין מ:

JANSSEN INC

קוד ATC:

N02AA03

INN (שם בינלאומי):

HYDROMORPHONE

כמות:

8MG

טופס פרצבטיות:

TABLET (EXTENDED-RELEASE)

הרכב:

HYDROMORPHONE HYDROCHLORIDE 8MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

7/10/30

סוג מרשם:

Narcotic (CDSA I)

איזור תרפויטי:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0108698005; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-10-31

מאפייני מוצר

_232334 APM.doc_
_ _
_Page 1 of 52 _
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_
_ _
_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
.....