DOM-DULOXETINE CAPSULE (DELAYED RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
05-05-2016
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Inapatikana kutoka:
DOMINION PHARMACAL
ATC kanuni:
N06AX21
INN (Jina la Kimataifa):
DULOXETINE
Kipimo:
30MG
Dawa fomu:
CAPSULE (DELAYED RELEASE)
Tungo:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0152350001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2016-05-02
Tabia za bidhaa
PRODUCT MONOGRAPH
Pr
DOM-DULOXETINE
Duloxetine Delayed-Release Capsules, House Standard
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
April 29, 2016
Submission Control No: 192825
_ _
_Dom-DULOXETINE Product Monograph _
_Page 2 of 78_
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
..................................................................................................18
DRUG INTERACTIONS
..................................................................................................35
DOSAGE AND ADMINISTRATION
..............................................................................39
OVERDOSAGE
................................................................................................................42
ACTION AND CLINICAL PHARMACOLOGY
............................................................43
STORAGE AND STABILITY
..........................................................................................46
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................46
PART II: SCIENTIFIC INFORMATION
................................................................................48
PHARMACEUTICAL INFORMATION
..........................................................................48
CLINICAL TRIALS
..........................................................................................................49
D
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