IPG-TRAMADOL/ACET TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN

Disponible des:

MARCAN PHARMACEUTICALS INC

Codi ATC:

N02AJ13

Designació comuna internacional (DCI):

TRAMADOL AND PARACETAMOL

Dosis:

37.5MG; 325MG

formulario farmacéutico:

TABLET

Composición:

TRAMADOL HYDROCHLORIDE 37.5MG; ACETAMINOPHEN 325MG

Vía de administración:

ORAL

Unidades en paquete:

30/500

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2016-01-07

Fitxa tècnica

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
IPG-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:
September 28, 2022
Submission
Control # 267549
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
.............................................................. 322
STORAGE AND STABILITY
............................................................................................39
SPECIAL HANDLING
INSTRUCTIONS...........................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................40
PART II: SCIENTIFIC INFORMATION
........................................................................
411
PHARMACEUTICAL INFORMATION
.................................................