FENTANYL CITRATE INJECTION USP SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FENTANYL (FENTANYL CITRATE)

Fáanlegur frá:

SANDOZ CANADA INCORPORATED

ATC númer:

N01AH01

INN (Alþjóðlegt nafn):

FENTANYL

Skammtar:

50MCG

Lyfjaform:

SOLUTION

Samsetning:

FENTANYL (FENTANYL CITRATE) 50MCG

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

2/5/10/20/50ML

Gerð lyfseðils:

Narcotic (CDSA I)

Lækningarsvæði:

OPIATE AGONISTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

1999-07-06

Vara einkenni

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FENTANYL CITRATE INJECTION SDZ
(Fentanyl Citrate Injection, USP)
(Fentanyl 50 mcg/mL as fentanyl citrate)
FENTANYL CITRATE INJECTION USP
(fentanyl 50 mcg/mL as fentanyl citrate)
Narcotic Analgesic
Adjunct to Anesthesia
Sandoz Canada Inc.
Date of Revision: May 8, 2018
145 Jules- Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 215796
_Fentanyl Citrate Injection SDZ / Fentanyl Citrate Injection USP _
_ _
_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
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMAC