País: Canadà
Idioma: anglès
Font: Health Canada
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
BRISTOL-MYERS SQUIBB CANADA
N02AJ17
OXYCODONE AND PARACETAMOL
2.5MG; 325MG
TABLET
OXYCODONE HYDROCHLORIDE 2.5MG; ACETAMINOPHEN 325MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0215596002; AHFS:
CANCELLED POST MARKET
2017-10-13
PERCOCET ® -DEMI (oxycodone hydrochloride and acetaminophen) Page 1 of 34 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N PERCOCET ® -DEMI (OXYCODONE HYDROCHLORIDE 2.5 MG / ACETAMINOPHEN 325 MG) TABLETS, USP OPIOID ANALGESIC Bristol-Myers Squibb Canada Montreal, Canada Date of Revision: October 17, 2016 Registered trademark of Endo Pharmaceuticals Inc. used under licence by Bristol-Myers Squibb Canada Submission Control No: 194810 PERCOCET ® -DEMI (oxycodone hydrochloride and acetaminophen) Page 2 of 34 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 .............................................................................................. 12 DRUG INTERACTIONS .............................................................................................. 14 DOSAGE AND ADMINISTRATION ........................................................................... 15 OVERDOSAGE ............................................................................................................ 18 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 20 STORAGE AND STABILITY ...................................................................................... 21 SPECIAL HANDLING INSTRUCTIONS .................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 21 PART II: SCIENTIFIC INFORMATION ............................................................................ 23 PHARMACEUTI Llegiu el document complet