FENTANYL CITRATE INJECTION SDZ SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

FENTANYL (FENTANYL CITRATE)

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

N01AH01

INN (Mezinárodní Name):

FENTANYL

Dávkování:

50MCG

Léková forma:

SOLUTION

Složení:

FENTANYL (FENTANYL CITRATE) 50MCG

Podání:

INTRAMUSCULAR

Jednotky v balení:

10ML

Druh předpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2012-01-20

Charakteristika produktu

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