JAMP-DULOXETINE CAPSULE (DELAYED RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Disponibbli minn:

JAMP PHARMA CORPORATION

Kodiċi ATC:

N06AX21

INN (Isem Internazzjonali):

DULOXETINE

Dożaġġ:

30MG

Għamla farmaċewtika:

CAPSULE (DELAYED RELEASE)

Kompożizzjoni:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2016-05-02

Karatteristiċi tal-prodott

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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
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_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