DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
06-02-2023
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Aktivna sestavina:
DESVENLAFAXINE
Dostopno od:
SANIS HEALTH INC
Koda artikla:
N06AX23
INN (mednarodno ime):
DESVENLAFAXINE
Odmerek:
50MG
Farmacevtska oblika:
TABLET (EXTENDED-RELEASE)
Sestava:
DESVENLAFAXINE 50MG
Pot uporabe:
ORAL
Enote v paketu:
15G/50G
Tip zastaranja:
Prescription
Povzetek izdelek:
Active ingredient group (AIG) number: 0152509001; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2023-02-06
Lastnosti izdelka
_ _
_DESVENLAFAXINE PRODUCT MONOGRAPH PAGE 1 OF 51 _
PRODUCT MONOGRAPH
PR
DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
Extended-release tablets, 50 mg and 100 mg Desvenlafaxine, Oral
Antidepressant
SANIS HEALTH INC.
1 PRESIDENT'S CHOICE CIRCLE
BRAMPTON, ONTARIO
L6Y 5S5
SUBMISSION CONTROL NUMBER: 270697
DATE OF
PREPARATION:
FEB
06, 2023
_ _
_DESVENLAFAXINE PRODUCT MONOGRAPH PAGE 2 OF 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
24
OVERDOSAGE
........................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
28
STORAGE AND STABILITY
.................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
P
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