MAR-TRAMADOL/ACET TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tersedia dari:

MARCAN PHARMACEUTICALS INC

Kode ATC:

N02AJ13

INN (Nama Internasional):

TRAMADOL AND PARACETAMOL

Dosis:

325MG; 37.5MG

Bentuk farmasi:

TABLET

Komposisi:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Rute administrasi :

ORAL

Unit dalam paket:

30/500

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2012-09-04

Karakteristik produk

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