NRA-TRAMADOL/ACET TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tilgængelig fra:

NORA PHARMA 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:

(1X30)/30/500

Recept type:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2018-07-03

Produktets egenskaber

1 | P a g e
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
NRA-TRAMADOL/ACET
Acetaminophen and Tramadol Hydrochloride Tablets, House Std.
37.5 mg tramadol hydrochloride/325
mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Nora Pharma Inc.
1565 Lionel-Boulet
Blvd.,
Varennes, QC, J3X 1P7
Canada
Date of Revision:
April 27, 2022
Control # 260240
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
...................................................................................................17
DRUG INTERACTIONS
....................................................................................................21
DOSAGE AND ADMINISTRATION
.................................................................................27
OVERDOSAGE
.................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
................................................................31
STORAGE AND STABILITY
............................................................................................38
SPECIAL HANDLING
INSTRUCTIONS...........................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................39
PART II: SCIENTIFIC INFORMATION
..........................................................................
40
PHARMACEUTICAL INFORMATION
...................................................................