JURNISTA TABLET (EXTENDED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

HYDROMORPHONE HYDROCHLORIDE

Disponibil de la:

JANSSEN INC

Codul ATC:

N02AA03

INN (nume internaţional):

HYDROMORPHONE

Dozare:

16MG

Forma farmaceutică:

TABLET (EXTENDED-RELEASE)

Compoziție:

HYDROMORPHONE HYDROCHLORIDE 16MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0108698014; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-10-31

Caracteristicilor produsului

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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
.....