FENTANYL CITRATE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FENTANYL (FENTANYL CITRATE)

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

N01AH01

INN (Διεθνής Όνομα):

FENTANYL

Δοσολογία:

50MCG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

FENTANYL (FENTANYL CITRATE) 50MCG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

2ML/20ML

Τρόπος διάθεσης:

Narcotic (CDSA I)

Θεραπευτική περιοχή:

OPIATE AGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2020-01-06

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
FENTANYL CITRATE INJECTION USP
50 mcg/mL Fentanyl (as Fentanyl Citrate)
Sterile Solution
THERAPEUTIC CLASSIFICATION
Narcotic Analgesic
Adjunct to Anesthesia
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
October 3, 2018
Submission Control No.: 219701
_Product Monograph - _
_N_
_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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
.............................................