JURNISTA TABLET (EXTENDED-RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

HYDROMORPHONE HYDROCHLORIDE

Disponibbli minn:

JANSSEN INC

Kodiċi ATC:

N02AA03

INN (Isem Internazzjonali):

HYDROMORPHONE

Dożaġġ:

32MG

Għamla farmaċewtika:

TABLET (EXTENDED-RELEASE)

Kompożizzjoni:

HYDROMORPHONE HYDROCHLORIDE 32MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30

Tip ta 'preskrizzjoni:

Narcotic (CDSA I)

Żona terapewtika:

OPIATE AGONISTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2018-10-31

Karatteristiċi tal-prodott

_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
.....