FENTANYL CITRATE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FENTANYL (FENTANYL CITRATE)

Disponibil de la:

JAMP PHARMA CORPORATION

Codul ATC:

N01AH01

INN (nume internaţional):

FENTANYL

Dozare:

50MCG

Forma farmaceutică:

SOLUTION

Compoziție:

FENTANYL (FENTANYL CITRATE) 50MCG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE AGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-10-23

Caracteristicilor produsului

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FENTANYL CITRATE INJECTION
Solution for injection
fentanyl 50 mcg / mL as fentanyl citrate
For epidural, intramuscular or slow intravenous administration
USP
Narcotic Analgesic
Adjunct to Anesthesia
Jamp Pharma Corporation
Date of Preparation: October 21, 2019
1310 rue Nobel
Boucherville, Québec,
Canada J4B 5H3
Submission Control No: 230156
_Fentanyl Citrate Injection. _
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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
..................................................................................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
PHARMACEUTICAL INFORMATION
................