TARO-TRAMADOL/ACET TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Mevcut itibaren:

SUN PHARMA CANADA INC

ATC kodu:

N02AJ13

INN (International Adı):

TRAMADOL AND PARACETAMOL

Doz:

325MG; 37.5MG

Farmasötik formu:

TABLET

Kompozisyon:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Narcotic (CDSA I)

Terapötik alanı:

OPIATE AGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2012-09-04

Ürün özellikleri

N
TARO-TRAMADOL/ACET – Product Monograph
Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TARO-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std.
37.5 mg tramadol hydrochloride / 325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Sun Pharma Canada Inc.
Date of Revision:
126 East Drive
October 25, 2023
Brampton, Ontario
L6T 1C1
Control No.: 272054
N
TARO-TRAMADOL/ACET – Product Monograph
Page 2 of 68
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
.....................................................................................
27
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
31
STORAGE AND STABILITY
.................................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 38
PART II: SCIENTIFIC INFORMATION
...............................................................................
39
PHARMACEUTICAL INFORMATION
.............