DEMEROL 50 MG/ML (SINGLE USE, PRESERVATIVE FREE) SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

MEPERIDINE HYDROCHLORIDE

제공처:

HOSPIRA HEALTHCARE ULC

ATC 코드:

N02AB02

INN (International Name):

PETHIDINE

복용량:

50MG

약제 형태:

SOLUTION

구성:

MEPERIDINE HYDROCHLORIDE 50MG

관리 경로:

INTRAMUSCULAR

패키지 단위:

1ML

처방전 유형:

Narcotic (CDSA I)

치료 영역:

OPIATE AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0104542001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2018-10-25

제품 특성 요약

_N_
_DEMEROL _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DEMEROL
(MEPERIDINE HYDROCHLORIDE INJECTION USP)
50 mg/mL, 75 mg/mL and 100 mg/mL
Sterile Solution
NARCOTIC ANALGESIC
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
April 26, 2018
Submission Control No: 212492
_N_
_DEMEROL _
_Page 2 of 33 _
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
PATIENT MEDI