JAMP-DULOXETINE CAPSULE (DELAYED RELEASE)

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Beszerezhető a:

JAMP PHARMA CORPORATION

ATC-kód:

N06AX21

INN (nemzetközi neve):

DULOXETINE

Adagolás:

30MG

Gyógyszerészeti forma:

CAPSULE (DELAYED RELEASE)

Összetétel:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Terápiás terület:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0152350001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2016-05-02

Termékjellemzők

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_JAMP-Duloxetine Product Monograph _
_ _
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_ Page 1 of 81 _
PRODUCT MONOGRAPH
PR JAMP-DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Submission Control No: 256492 DATE OF REVISION: September 28, 2021
JAMP Pharma Corporation
1310 rue Nobel
Boucherville,
Québec
J4B 5H3, Canada
______________________________________________________________________________
_JAMP-Duloxetine Product Monograph _
_ _
_ _
_ Page 2 of 81 _
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
................................................................................................
18
DRUG INTERACTIONS
................................................................................................
37
DOSAGE AND ADMINISTRATION
............................................................................
40
OVERDOSAGE
..............................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 44
STORAGE AND STABILITY
........................................................................................
47
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 47
PART II: SCIENTIFIC INFORMATION
..............................................................................
49
PHARMA