Страна: Канада
Язык: английский
Источник: Health Canada
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
LUPIN PHARMA CANADA LIMITED
N02AJ13
TRAMADOL AND PARACETAMOL
37.50MG; 325.00MG
TABLET
TRAMADOL HYDROCHLORIDE 37.50MG; ACETAMINOPHEN 325.00MG
ORAL
10/60
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0250601001; AHFS:
CANCELLED PRE MARKET
2021-11-05
_ _ _ _ _ _ _Page 1 of 64_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR LUPIN-TRAMADOL/ACET House Standard acetaminophen and tramadol hydrochloride tablets 37.5 mg tramadol hydrochloride/325 mg acetaminophen Centrally Acting Analgesic Lupin Pharma Canada Limited 1155 René-Lévesque West Blvd. Suite 2500 Montreal QC H3B 2K4 Date of Revision: July 19, 2018 SUBMISSION CONTROL NO: 216388 _ _ _ _ _ _ _Page 2 of 64_ 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 ................................................................................. 24 OVERDOSAGE ................................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 28 STORAGE AND STABILITY ............................................................................................. 35 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 35 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 35 PART II: SCIENTIFIC INFORMATION ............................................................................... 37 PHARMACEUTICAL INFORMA Прочитать полный документ