TRAMADOL-ACET TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Mevcut itibaren:

PRO DOC LIMITEE

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:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2019-09-11

Ürün özellikleri

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRAMADOL-ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
PRO DOC LTÉE
Date of Revision:
2925, boul. Industriel
December 12, 2018
Laval, Quebec
H7L 3W9
SUBMISSION CONTROL NUMBER: 221949
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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
................................................................ 25
OVERDOSAGE
.............................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................ 29
STORAGE AND STABILITY
..........................................................................
36
SPECIAL HANDLING INSTRUCTIONS
....................................................... 37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 37
PART II: SCIENTIFIC INFORMATION
................................................................. 38
PHARMACEUTICAL INFORMATION
............................................................ 38
CLINICAL TRIALS
........................................................................................
39
DETAILED PHARMACOLOGY
......................................................................
43
TOXICOLOGY...............................