IPG-DULOXETINE CAPSULE (DELAYED RELEASE)
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
28-04-2017
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Aktívna zložka:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Dostupné z:
MARCAN PHARMACEUTICALS INC
ATC kód:
N06AX21
INN (Medzinárodný Name):
DULOXETINE
Dávkovanie:
60MG
Forma lieku:
CAPSULE (DELAYED RELEASE)
Zloženie:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Spôsob podávania:
ORAL
Počet v balení:
8/30/1000
Typ predpisu:
Prescription
Terapeutické oblasti:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Prehľad produktov:
Active ingredient group (AIG) number: 0152350002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2016-05-02
Súhrn charakteristických
Page 1 of 77
PRODUCT MONOGRAPH
PR
IPG-DULOXETINE
Duloxetine Delayed - Release Capsules, Mfr. Std.
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
MARCAN PHARMACEUTICALS INC. DATE OF REVISION:
77 AURIGA DRIVE, UNIT# 4 APRIL 25, 2017
OTTAWA, ON
CANADA K2E 7Z7
Control # 204721
Page 2 of 77
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
.......................................................................................................................
17
DRUG INTERACTIONS
.......................................................................................................................
35
DOSAGE AND ADMINISTRATION
...................................................................................................
38
OVERDOSAGE
......................................................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
42
STORAGE AND STABILITY
...............................................................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 46
PART II: SCIENTIFIC INFORMATION
.........................................................................................
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