FENTANYL INJECTION BP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FENTANYL (FENTANYL CITRATE)

Disponible depuis:

STERIMAX INC

Code ATC:

N01AH01

DCI (Dénomination commune internationale):

FENTANYL

Dosage:

2500MCG

forme pharmaceutique:

SOLUTION

Composition:

FENTANYL (FENTANYL CITRATE) 2500MCG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

15G/50G

Type d'ordonnance:

Narcotic (CDSA I)

Domaine thérapeutique:

OPIATE AGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-02-10

Résumé des caractéristiques du produit

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 _
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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
................................