PRO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
11-01-2023
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Aktivna sestavina:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Dostopno od:
PRO DOC LIMITEE
Koda artikla:
N06AX23
INN (mednarodno ime):
DESVENLAFAXINE
Odmerek:
100MG
Farmacevtska oblika:
TABLET (EXTENDED-RELEASE)
Sestava:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG
Pot uporabe:
ORAL
Enote v paketu:
15G/50G
Tip zastaranja:
Prescription
Povzetek izdelek:
Active ingredient group (AIG) number: 0152509002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2022-04-29
Lastnosti izdelka
_PRO-DESVENLAFAXINE PRODUCT MONOGRAPH _
PAGE 1 OF 50
PRODUCT MONOGRAPH
PR
PRO-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate)
ANTIDEPRESSANT
DATE OF REVISION:
JAN 10, 2023
CONTROL NUMBER: 270605
PRO DOC LTÉE
2925 BOULEVARD INDUSTRIEL
LAVAL, QUEBEC
H7L 3W9
_PRO-DESVENLAFAXINE PRODUCT MONOGRAPH _
PAGE 2 OF 50
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
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
.....................................................................................
25
OVERDOSAGE
........................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL INFORM
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