AG-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
28-02-2022
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Aktivna sestavina:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Dostopno od:
ANGITA PHARMA INC.
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:
2022-03-04
Lastnosti izdelka
PRODUCT MONOGRAPH
Pr
AG-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 and 100 mg desvenlafaxine (as desvenlafaxine succinate monohydrate)
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
SUBMISSION CONTROL NO.: 260512
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph _
_Page 1 of 57_
Date of Revision:
February
28, 2022
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph_
_Page 2 of 57_
_ _
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
....................................................................................................
13
DRUG INTERACTIONS
....................................................................................................24
DOSAGE AND ADMINISTRATION
................................................................................28
OVERDOSAGE
...................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................33
STORAGE AND STABILITY
............................................................................................37
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................37
PART II: SCIENTIFIC INFORMATION
..................................................................................
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