AG-ACET-TRAMADOL TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
04-01-2023
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Aktiv ingrediens:
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Tilgjengelig fra:
ANGITA PHARMA INC.
ATC-kode:
N02AJ13
INN (International Name):
TRAMADOL AND PARACETAMOL
Dosering :
37.5MG; 325MG
Legemiddelform:
TABLET
Sammensetning:
TRAMADOL HYDROCHLORIDE 37.5MG; ACETAMINOPHEN 325MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Narcotic (CDSA I)
Terapeutisk område:
OPIATE AGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0250601001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2018-06-15
Preparatomtale
AG-Acet-Tramadol(Acetaminophen and Tramadol Hydrochloride Tablets)
Page 1 of 66
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
AG-ACET-TRAMADOL
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Revision:
JAN 3, 2023
Control # 270081
AG-Acet-Tramadol(Acetaminophen and Tramadol Hydrochloride Tablets)
Page 2 of 66
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
............................................................................................
278
OVERDOSAGE
.................................................................................................................................
301
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
312
STORAGE AND STABILITY
..........................................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
......................................................................................
38
DOS
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