FENTANYL CITRATE INJECTION USP SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

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Ladda ner Produktens egenskaper (SPC)
24-05-2022

Aktiva substanser:

FENTANYL (FENTANYL CITRATE)

Tillgänglig från:

HIKMA CANADA LIMITED

ATC-kod:

N02AB03

INN (International namn):

FENTANYL

Dos:

50MCG

Läkemedelsform:

SOLUTION

Sammansättning:

FENTANYL (FENTANYL CITRATE) 50MCG

Administreringssätt:

INTRAMUSCULAR

Enheter i paketet:

2ML/10ML

Receptbelagda typ:

Narcotic (CDSA I)

Terapiområde:

OPIATE AGONISTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-09-02

Produktens egenskaper

                                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.................................................................
                                
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