FENTANYL INJECTION BP SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

FENTANYL (FENTANYL CITRATE)

MAH:

STERIMAX INC

ATC_code:

N01AH01

INN:

FENTANYL

dosage:

250MCG

pharmaceutical_form:

SOLUTION

composition:

FENTANYL (FENTANYL CITRATE) 250MCG

administration_route:

INTRAMUSCULAR

units_in_package:

15G/50G

prescription_type:

Narcotic (CDSA I)

therapeutic_area:

OPIATE AGONISTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2020-02-10

SPC

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Ⓝ
FENTANYL INJECTION BP
Fentanyl 50 mcg/mL as fentanyl citrate
Narcotic Analgesic
Adjunct to Anesthesia
SteriMax Inc.
Date of Preparation: February 6, 2020
2770 Portland Drive
Oakville, ON Canada
L6H 6R4
Submission Control No: 227834
_FENTANYL INJECTION BP _
_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
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
.............................................................21
STORAGE AND STABILITY
..............................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
........................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
DETAILED PHARMACOLOGY
................................