MINT-TRAMADOL/ACET TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

N02AJ13

INN (International Name):

TRAMADOL AND PARACETAMOL

Dosering:

325MG; 37.5MG

Lægemiddelform:

TABLET

Sammensætning:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

60/100

Recept type:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0250601001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2012-09-04

Produktets egenskaber

1 | P a g e
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MINT-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario, L5T 2M3
Date of Revision:
March 6, 2023
Submission Control #: 269513
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
.........................................................................................................
18
DRUG INTERACTIONS
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
...................................................................................
288
OVERDOSAGE
......................................................................................................................
311
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 332
STORAGE AND STABILITY
.................................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
411
PHARM