PAT-TRAMADOL/ACET TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

제공처:

PATRIOT A DIVISION OF JANSSEN INC

ATC 코드:

N02AJ13

INN (International Name):

TRAMADOL AND PARACETAMOL

복용량:

325MG; 37.5MG

약제 형태:

TABLET

구성:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

관리 경로:

ORAL

패키지 단위:

60

처방전 유형:

Narcotic (CDSA I)

치료 영역:

OPIATE AGONISTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2014-11-11

제품 특성 요약

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PRODUCT MONOGRAPH
PR
PAT-TRAMADOL/ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.patriot-canada.ca
Date of Preparation:
July 9, 2012
Date of Revision:
September 5, 2014
SUBMISSION CONTROL NO: 177222
© 2014 Patriot, a Division of Janssen Inc.
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_Page 2 of 40 _
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
.........................................................................................................
10
DRUG ABUSE, ADDICTION AND DEPENDENCE
............................................................ 12
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
.........................................