TRAMADOL / ACETAMINOPHEN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Saatavilla:

SIVEM PHARMACEUTICALS ULC

ATC-koodi:

N02AJ13

INN (Kansainvälinen yleisnimi):

TRAMADOL AND PARACETAMOL

Annos:

325MG; 37.5MG

Lääkemuoto:

TABLET

Koostumus:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Antoreitti:

ORAL

Kpl paketissa:

60/100

Prescription tyyppi:

Narcotic (CDSA I)

Terapeuttinen alue:

OPIATE AGONISTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2019-08-12

Valmisteyhteenveto

_TRAMADOL/ACETAMINOPHEN Product Monograph _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRAMADOL/ACETAMINOPHEN
Tramadol Hydrochloride and Acetaminophen Tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control No: 244140
Date of Revision:
February 9, 2021
_TRAMADOL/ACETAMINOPHEN Product Monograph _
_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................................................
3
CONTRAINDICATIONS
.........................................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................................................
5
ADVERSE REACTIONS
........................................................................................................................................
17
DRUG INTERACTIONS
........................................................................................................................................
21
DOSAGE AND ADMINISTRATION
......................................................................................................................
26
OVERDOSAGE
....................................................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................................................
30
STORAGE AND STA