CO FENTANYL PATCH

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FENTANYL

Διαθέσιμο από:

COBALT PHARMACEUTICALS COMPANY

Φαρμακολογική κατηγορία (ATC):

N02AB03

INN (Διεθνής Όνομα):

FENTANYL

Δοσολογία:

12MCG

Φαρμακοτεχνική μορφή:

PATCH

Σύνθεση:

FENTANYL 12MCG

Οδός χορήγησης:

TRANSDERMAL

Μονάδες σε πακέτο:

5

Τρόπος διάθεσης:

Narcotic (CDSA I)

Θεραπευτική περιοχή:

OPIATE AGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0123302015; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-05-17

Αρχείο Π.Χ.Π.

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_CO _FENTANYL_ _
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PRODUCT MONOGRAPH
N
_CO_ FENTANYL
Fentanyl Transdermal Patches (Matrix)
12 mcg/h
25 mcg/h
37 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
Opioid Analgesic
Cobalt Pharmaceuticals Company
Date of Revision:
6733 Mississauga Road, Suite 400
August 23, 2017
Mississauga, Ontario
L5N 6J5
Submission Control No.: 208560
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_CO _FENTANYL_ _
_Page 2 of 49_
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
..........................................................................................................
14
DRUG
INTERACTIONS
...........................................................................................................
17
DOSAGE
AND
ADMINISTRATION
.......................................................................................
18
OVERDOSAGE
.........................................................................................................................
25
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
26
STORAGE
AND
STABILITY...................................................................................................
28
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 29
PART II: SCIENTIFIC INFORMATION
................................................................................
31
PHARMACE