FENTANYL CITRATE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENTANYL (FENTANYL CITRATE)

Available from:

PFIZER CANADA ULC

ATC code:

N01AH01

INN (International Name):

FENTANYL

Dosage:

50MCG

Pharmaceutical form:

SOLUTION

Composition:

FENTANYL (FENTANYL CITRATE) 50MCG

Administration route:

INTRAMUSCULAR

Units in package:

2ML/20ML

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-01-06

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
FENTANYL CITRATE INJECTION USP
50 mcg/mL Fentanyl (as Fentanyl Citrate)
Sterile Solution
THERAPEUTIC CLASSIFICATION
Narcotic Analgesic
Adjunct to Anesthesia
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
October 3, 2018
Submission Control No.: 219701
_Product Monograph - _
_N_
_FENTANYL CITRATE INJECTION USP _
_Page 2 of 44 _
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
..............................................................................16
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
.............................................