SANDOZ DULOXETINE CAPSULE (DELAYED RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
03-06-2022
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Fáanlegur frá:
SANDOZ CANADA INCORPORATED
ATC númer:
N06AX21
INN (Alþjóðlegt nafn):
DULOXETINE
Skammtar:
60MG
Lyfjaform:
CAPSULE (DELAYED RELEASE)
Samsetning:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0152350002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2016-05-02
Vara einkenni
______________________________________________________________________________
_Sandoz Duloxetine Product Monograph_
_ Page 1 of 84_
PRODUCT MONOGRAPH
PR SANDOZ DULOXETINE
Duloxetine Delayed-Release Capsules
30 mg and 60 mg duloxetine (as duloxetine hydrochloride)
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville,
Quebec
J4B 1E6
Submission
Control No: 259736 DATE OF REVISION: June 3, 2022
______________________________________________________________________________
_Sandoz Duloxetine Product Monograph_
_ Page 2 of 84_
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
................................................................................................
39
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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