FENTANYL INJECTION BP SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

FENTANYL (FENTANYL CITRATE)

Dostupné s:

STERIMAX INC

ATC kód:

N01AH01

INN (Mezinárodní Name):

FENTANYL

Dávkování:

250MCG

Léková forma:

SOLUTION

Složení:

FENTANYL (FENTANYL CITRATE) 250MCG

Podání:

INTRAMUSCULAR

Jednotky v balení:

15G/50G

Druh předpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2020-02-10

Charakteristika produktu

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