TRAMADOL/ACET TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

제공처:

SANIS HEALTH INC

ATC 코드:

N02AJ13

INN (국제 이름):

TRAMADOL AND PARACETAMOL

복용량:

325MG; 37.5MG

약제 형태:

TABLET

구성:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

관리 경로:

ORAL

패키지 단위:

100

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:

2020-12-16

제품 특성 요약

Page
1
of
64
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
SANIS HEALTH INC.
Date of Revision:
1 President’s Choice Circle November 27, 2018
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NUMBER: 221806
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
................................................................ 25
OVERDOSAGE
.............................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................ 29
STORAGE AND STABILITY
..........................................................................
35
SPECIAL HANDLING INSTRUCTIONS
....................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 36
PART II: SCIENTIFIC INFORMATION
................................................................. 37
PHARMACEUTICAL INFORMATION
............................................................ 37
CLINICAL TRIALS
........................................................................................
38
DETAILED PHARMACOLOGY
......................................................................
42
TOXICOLOGY................