LUPIN-TRAMADOL/ACET TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN

Tersedia dari:

LUPIN PHARMA CANADA LIMITED

Kode ATC:

N02AJ13

INN (Nama Internasional):

TRAMADOL AND PARACETAMOL

Dosis:

37.50MG; 325.00MG

Bentuk farmasi:

TABLET

Komposisi:

TRAMADOL HYDROCHLORIDE 37.50MG; ACETAMINOPHEN 325.00MG

Rute administrasi :

ORAL

Unit dalam paket:

10/60

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2021-11-05

Karakteristik produk

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_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPIN-TRAMADOL/ACET
House Standard
acetaminophen and tramadol hydrochloride tablets
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
Lupin Pharma Canada Limited
1155 René-Lévesque West Blvd.
Suite 2500
Montreal QC
H3B 2K4
Date of Revision:
July 19, 2018
SUBMISSION CONTROL NO: 216388
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_Page 2 of 64_
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
.................................................................................
24
OVERDOSAGE
...................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 28
STORAGE AND STABILITY
.............................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 35
PART II: SCIENTIFIC INFORMATION
...............................................................................
37
PHARMACEUTICAL INFORMA