FENTANYL CITRATE INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FENTANYL (FENTANYL CITRATE)

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

N01AH01

INN (Διεθνής Όνομα):

FENTANYL

Δοσολογία:

50MCG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

FENTANYL (FENTANYL CITRATE) 50MCG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Narcotic (CDSA I)

Θεραπευτική περιοχή:

OPIATE AGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-10-23

Αρχείο Π.Χ.Π.

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. _
_Page 2 of 45_
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
................