Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE); NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE)
PHARMASCIENCE INC
N07BC51
BUPRENORPHINE, COMBINATIONS
2MG; 0.5MG
TABLET
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5MG
SUBLINGUAL
30
Narcotic (CDSA I)
OPIATE PARTIAL AGONISTS
Active ingredient group (AIG) number: 0252216001; AHFS:
APPROVED
2014-05-07
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N PMS-BUPRENORPHINE-NALOXONE Buprenorphine and Naloxone Sublingual Tablet Sublingual Tablet; buprenorphine (as buprenorphine hydrochloride) / naloxone (as naloxone hydrochloride dihydrate), 2 mg / 0.5 mg and 8 mg / 2 mg USP Partial Opioid Agonist and Opioid Antagonist PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 www.pharmascience.com Date of Initial Authorization: May 7, 2014 Date of Revision: September 25, 2023 Submission Control No: _pms-BUPRENORPHINE-NALOXONE Product Monograph _ _ _ _Page 2 of 63_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 09/2023 7 WARNINGS AND PRECAUTIONS, Gastro-intestinal 09/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................... 2 TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................... 4 1 INDICATIONS .................................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 6 4.1 Dosing Considerations .............................................................. Կարդացեք ամբողջական փաստաթուղթը