País: Canadá
Idioma: inglés
Fuente: Health Canada
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
NORA PHARMA INC
N02AJ13
TRAMADOL AND PARACETAMOL
325MG; 37.5MG
TABLET
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
ORAL
(1X30)/30/500
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0250601001; AHFS:
APPROVED
2018-07-03
1 | P a g e PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N NRA-TRAMADOL/ACET Acetaminophen and Tramadol Hydrochloride Tablets, House Std. 37.5 mg tramadol hydrochloride/325 mg acetaminophen Opioid Analgesic and Centrally Acting Analgesic Nora Pharma Inc. 1565 Lionel-Boulet Blvd., Varennes, QC, J3X 1P7 Canada Date of Revision: April 27, 2022 Control # 260240 2 | P a g e TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION........................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................ 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS.................................................................................... 4 ADVERSE REACTIONS ...................................................................................................17 DRUG INTERACTIONS ....................................................................................................21 DOSAGE AND ADMINISTRATION .................................................................................27 OVERDOSAGE .................................................................................................................29 ACTION AND CLINICAL PHARMACOLOGY ................................................................31 STORAGE AND STABILITY ............................................................................................38 SPECIAL HANDLING INSTRUCTIONS...........................................................................39 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................39 PART II: SCIENTIFIC INFORMATION .......................................................................... 40 PHARMACEUTICAL INFORMATION ................................................................... Leer el documento completo