Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
HYDROMORPHONE HYDROCHLORIDE
JANSSEN INC
N02AA03
HYDROMORPHONE
32MG
TABLET (EXTENDED-RELEASE)
HYDROMORPHONE HYDROCHLORIDE 32MG
ORAL
30
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0108698013; AHFS:
CANCELLED POST MARKET
2018-10-31
_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 ..... Prečítajte si celý dokument