PHL-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Διαθέσιμο από:

PHARMEL INC

Φαρμακολογική κατηγορία (ATC):

N06AX16

INN (Διεθνής Όνομα):

VENLAFAXINE

Δοσολογία:

37.5MG

Φαρμακοτεχνική μορφή:

CAPSULE (EXTENDED RELEASE)

Σύνθεση:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131294002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2017-09-13

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
PHL-VENLAFAXINE XR
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
37.5 MG, 75 MG AND 150 MG VENLAFAXINE, AS VENLAFAXINE HYDROCHLORIDE
Antidepressant
PHARMEL INC.
6111 Royalmount Ave, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
February 28, 2013
Submission Control No: 116572, 151423, 162397
_ _
_phl-VENLAFAXINE XR Product Monograph _
_Page 2 of 54 _
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
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................30
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................37
SPECIAL HANDLING INSTRUCTIONS
.......................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................38
PART II: SCIENTIFIC INFORMATION
...............................................................................39
PHARMACEUTICAL INFORMATION
..........................................................................39
CLINICAL TR