MAR-TRAMADOL/ACET TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
25-01-2023

유효 성분:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

제공처:

MARCAN PHARMACEUTICALS 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:

30/500

처방전 유형:

Narcotic (CDSA I)

치료 영역:

OPIATE AGONISTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2012-09-04

제품 특성 요약

                                1 | P a g e
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MAR-TRAMADOL/ACET
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Revision:
JAN 24, 2023
Control # 271044
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
.........................................................................................................
17
DRUG INTERACTIONS
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
...................................................................................
288
OVERDOSAGE
......................................................................................................................
311
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 332
STORAGE AND STABILITY
.................................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
411
PHARMACEUTICAL INF
                                
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