MYLAN-DULOXETINE CAPSULE (DELAYED RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
06-10-2016
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:
MYLAN PHARMACEUTICALS ULC
ATC kanuni:
N06AX21
INN (Jina la Kimataifa):
DULOXETINE
Kipimo:
60MG
Dawa fomu:
CAPSULE (DELAYED RELEASE)
Tungo:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30/100/500
Dawa ya aina:
Prescription
Eneo la matibabu:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0152350002; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2018-05-10
Tabia za bidhaa
_MYLAN-DULOXETINE Product Monograph_
Page 1 of 86
PRODUCT MONOGRAPH
PR MYLAN-DULOXETINE
Duloxetine Delayed Release Capsules, Mylan Standard
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 198303
Date of Revision: September 29, 2016
_MYLAN-DULOXETINE Product Monograph_
Page 2 of 86
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
6
ADVERSE REACTIONS
.........................................................................................................
19
DRUG INTERACTIONS
.........................................................................................................
38
DOSAGE AND ADMINISTRATION
.....................................................................................
42
OVERDOSAGE
........................................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
46
STORAGE AND STABILITY
.................................................................................................
49
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 49
PART II: SCIENTIFIC INFORMATION
.........................................................................................
51
PHARMACEUTICAL INFORMATION
.....................................................
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