TRAMAPHEN-ODAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tersedia dari:

ODAN LABORATORIES LTD

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:

100/500

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2014-10-31

Karakteristik produk

1 | P a g e
PRODUCT MONOGRAPH
PR
TRAMAPHEN-ODAN
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
ODAN LABORATORIES LTD.
DATE OF PREPARATION:
325 STILLVIEW AVENUE
JULY 3, 2012
POINTE-CLAIRE, QC
CANADA H9R 2Y6
Control# 156402
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
...................................................................................................................
9
DRUG ABUSE, ADDICTION AND DEPENDENCE
...........................................................................
12
DRUG INTERACTIONS
.................................................................................................................
13
DOSAGE AND ADMINISTRATION
...............................................................................................
14
OVERDOSAGE
.............................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
17
STORAGE AND STABILITY
...........................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 21
PART II: SCIENTIFIC INFORMATION
........................