FENTANYL CITRATE INJECTION USP SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FENTANYL (FENTANYL CITRATE)

Fáanlegur frá:

HIKMA CANADA LIMITED

ATC númer:

N02AB03

INN (Alþjóðlegt nafn):

FENTANYL

Skammtar:

50MCG

Lyfjaform:

SOLUTION

Samsetning:

FENTANYL (FENTANYL CITRATE) 50MCG

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

2ML/10ML

Gerð lyfseðils:

Narcotic (CDSA I)

Lækningarsvæði:

OPIATE AGONISTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-09-02

Vara einkenni

Fentanyl Citrate Injection USP
Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FENTANYL CITRATE INJECTION USP
(fentanyl 50 mcg / mL as fentanyl citrate)
Narcotic Analgesic
Adjunct to Anesthesia
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Preparation: May 24, 2022
Control No. 263327
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............................................................................4
ADVERSE
REACTIONS...........................................................................................12
DRUG
INTERACTIONS............................................................................................14
DOSAGE AND
ADMINISTRATION..........................................................................15
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.................................................................