Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
PENTAZOCINE (PENTAZOCINE HYDROCHLORIDE)
SANOFI-AVENTIS CANADA INC
N02AD01
PENTAZOCINE
50MG
TABLET
PENTAZOCINE (PENTAZOCINE HYDROCHLORIDE) 50MG
ORAL
100/500
Narcotic (CDSA I)
OPIATE PARTIAL AGONISTS
Active ingredient group (AIG) number: 0108852002; AHFS:
CANCELLED POST MARKET
2021-02-19
_Page 1 of 32 _ PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION Ⓝ TALWIN ® pentazocine hydrochloride Tablets, 50 mg Narcotic Analgesic sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval, Quebec H7V 0A3 Date of Revision: May 22, 2018 Submission Control No: 213122 _Page 2 of 32 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................16 OVERDOSAGE ................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................23 PHARMACEUTICAL INFORMATION ..........................................................................23 PART III: CONSUMER MEDICATION INFORMATION ..................................................24 _Page 3 of 32 _ Ⓝ TALWIN ® pentazocine hydrochloride tablets PART I: HEALTH PROFESSIONAL INFORMATI Soma hati kamili