TARO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
19-10-2022
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Aktivna sestavina:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Dostopno od:
TARO PHARMACEUTICALS INC
Koda artikla:
N06AX23
INN (mednarodno ime):
DESVENLAFAXINE
Odmerek:
50MG
Farmacevtska oblika:
TABLET (EXTENDED-RELEASE)
Sestava:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 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:
2022-10-20
Lastnosti izdelka
PRODUCT MONOGRAPH
PR TARO-DESVENLAFAXINE
desvenlafaxine extended-release tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate
monohydrate
)
Antidepressant
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
OCT 19, 2022
Brampton, Ontario
L6T 1C1
Submission Control No.: 264187
_________________________________________________________________________________________
_Taro-Desvenlafaxine (desvenlafaxine succinate monohydrate) Product
Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFOR
M
ATION
.............................................................................
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
...........................................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................28
STORAGE AND STABILITY
....................................................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.
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