Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
SUN PHARMA CANADA INC
N02AJ13
TRAMADOL AND PARACETAMOL
325MG; 37.5MG
TABLET
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0250601001; AHFS:
APPROVED
2012-09-04
N TARO-TRAMADOL/ACET – Product Monograph Page 1 of 68 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N TARO-TRAMADOL/ACET Acetaminophen and Tramadol hydrochloride tablets, House Std. 37.5 mg tramadol hydrochloride / 325 mg acetaminophen Opioid Analgesic and Centrally Acting Analgesic Sun Pharma Canada Inc. Date of Revision: 126 East Drive October 25, 2023 Brampton, Ontario L6T 1C1 Control No.: 272054 N TARO-TRAMADOL/ACET – Product Monograph Page 2 of 68 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 ........................................................................................................................ 30 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 31 STORAGE AND STABILITY ................................................................................................. 38 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 38 PART II: SCIENTIFIC INFORMATION ............................................................................... 39 PHARMACEUTICAL INFORMATION ............. Đọc toàn bộ tài liệu