FENTANYL CITRATE INJECTION USP SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
08-05-2018

유효 성분:

FENTANYL (FENTANYL CITRATE)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

N01AH01

INN (국제 이름):

FENTANYL

복용량:

50MCG

약제 형태:

SOLUTION

구성:

FENTANYL (FENTANYL CITRATE) 50MCG

관리 경로:

INTRAMUSCULAR

패키지 단위:

2/5/10/20/50ML

처방전 유형:

Narcotic (CDSA I)

치료 영역:

OPIATE AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0123302002; AHFS:

승인 상태:

APPROVED

승인 날짜:

1999-07-06

제품 특성 요약

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FENTANYL CITRATE INJECTION SDZ
(Fentanyl Citrate Injection, USP)
(Fentanyl 50 mcg/mL as fentanyl citrate)
FENTANYL CITRATE INJECTION USP
(fentanyl 50 mcg/mL as fentanyl citrate)
Narcotic Analgesic
Adjunct to Anesthesia
Sandoz Canada Inc.
Date of Revision: May 8, 2018
145 Jules- Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 215796
_Fentanyl Citrate Injection SDZ / Fentanyl Citrate Injection USP _
_ _
_Page 2 of 46 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMAC
                                
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