FENTANYL CITRATE INJECTION, USP SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FENTANYL (FENTANYL CITRATE)

Mevcut itibaren:

FRESENIUS KABI CANADA LTD

ATC kodu:

N01AH01

INN (International Adı):

FENTANYL

Doz:

50MCG

Farmasötik formu:

SOLUTION

Kompozisyon:

FENTANYL (FENTANYL CITRATE) 50MCG

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

15G/50G

Reçete türü:

Narcotic (CDSA I)

Terapötik alanı:

OPIATE AGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2020-07-03

Ürün özellikleri

Fentanyl Citrate Injection, USP
Page 1 of 46
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
FENTANYL CITRATE INJECTION, USP
(fentanyl 50 mcg / mL as fentanyl citrate)
Narcotic Analgesic
Adjunct to Anesthesia
Fresenius Kabi Canada Ltd.
Date of Preparation: July 2, 2020
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Submission Control No: 222517
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
...............................................................................................
14
DOSAGE AND ADMINISTRATION
...........................................................................
16
OVERDOSAGE
.............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 21
STORAGE AND STABILITY
......................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
....................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 25
PART II : SCIENTIFIC INFORMATION
............................................................................
26
PHARMACEUTICAL INFORMATION
......................................................................
26
DETAILED PHARMACOLOGY
......