M-DULOXETINE CAPSULE (DELAYED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

متاح من:

MANTRA PHARMA INC

ATC رمز:

N06AX21

INN (الاسم الدولي):

DULOXETINE

جرعة:

60MG

الشكل الصيدلاني:

CAPSULE (DELAYED RELEASE)

تركيب:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0152350002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-02-22

خصائص المنتج

PRODUCT MONOGRAPH
PR
M-DULOXETINE
Duloxetine Delayed Release Capsules USP
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
MANTRA PHARMA INC.
Date of Revision:
9150 BOUL. LEDUC, SUITE 201,
November 16, 2021
BROSSARD, QUEBEC, CANADA
J4Y 0E3
Control Number: 257928
_M-DULOXETINE_ (duloxetine hydrochloride)
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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
...............................................................................................................
36
DOSAGE AND ADMINISTRATION
...........................................................................................
39
OVERDOSAGE
.............................................................................................................................
42
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
42
STORAGE AND
STABILITY.......................................................................................................
46
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 46
PART II: SCIENTIFIC
INFORMATION....................................................................................
46
PHARMACEUTICAL INFORMATION
..........................................................