FENTANYL CITRATE INJECTION SDZ SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FENTANYL (FENTANYL CITRATE)

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

N01AH01

INN (Међународно име):

FENTANYL

Дозирање:

50MCG

Фармацеутски облик:

SOLUTION

Састав:

FENTANYL (FENTANYL CITRATE) 50MCG

Пут администрације:

INTRAMUSCULAR

Јединице у пакету:

10ML

Тип рецептора:

Narcotic (CDSA I)

Терапеутска област:

OPIATE AGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0123302011; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2012-01-20

Карактеристике производа

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 _
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_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