Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
JAMP PHARMA CORPORATION
N02AJ13
TRAMADOL AND PARACETAMOL
325MG; 37.5MG
TABLET
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
ORAL
60/100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0250601001; AHFS:
APPROVED
2012-09-04
1 | P a g e PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N JAMP-ACET-TRAMADOL Acetaminophen and Tramadol hydrochloride tablets, House Std 37.5 mg tramadol hydrochloride/325 mg acetaminophen Opioid Analgesic and Centrally Acting Analgesic JAMP Pharma Corporation 1310, rue Nobel Boucherville, Québec J4B 5H3, Canada Date of Revision: May 16, 2023 Control # 270861 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 ................................................................................................... 22 DOSAGE AND ADMINISTRATION .............................................................................. 288 OVERDOSAGE .............................................................................................................. 311 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 322 STORAGE AND STABILITY ........................................................................................... 39 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 39 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................. 40 PART II: SCIENTIFIC INFORMATION ........................................................................ 411 PHARMACEUTICAL INFORMATION ................................................................... Izlasiet visu dokumentu