MAR-TRAMADOL/ACET TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tillgänglig från:

MARCAN PHARMACEUTICALS INC

ATC-kod:

N02AJ13

INN (International namn):

TRAMADOL AND PARACETAMOL

Dos:

325MG; 37.5MG

Läkemedelsform:

TABLET

Sammansättning:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Administreringssätt:

ORAL

Enheter i paketet:

30/500

Receptbelagda typ:

Narcotic (CDSA I)

Terapiområde:

OPIATE AGONISTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2012-09-04

Produktens egenskaper

1 | P a g e
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MAR-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Revision:
JAN 24, 2023
Control # 271044
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
.........................................................................................................
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
PHARMACEUTICAL INF