Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
VILAZODONE HYDROCHLORIDE; VILAZODONE HYDROCHLORIDE; VILAZODONE HYDROCHLORIDE
FOREST LABORATORIES CANADA INC
N06AX24
VILAZODONE
10MG; 20MG; 40MG
KIT
VILAZODONE HYDROCHLORIDE 10MG; VILAZODONE HYDROCHLORIDE 20MG; VILAZODONE HYDROCHLORIDE 40MG
ORAL
7X10MG-7X20MG-16X40MG
Prescription
SEROTONIN MODULATORS
Active ingredient group (AIG) number: 0357131001; AHFS:
CANCELLED PRE MARKET
2018-09-13
_VIIBRYD_ _TM_ _ Product Monograph _ _Page 1 of 41 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VIIBRYD TM vilazodone hydrochloride 10 mg, 20 mg, 40 mg tablets ANTIDEPRESSANT Forest Laboratories Canada Inc. 6733 Mississauga Road, Suite 400 Mississauga, Ontario L6N 6J5 DATE OF PREPARATION: JULY 15, 2015 SUBMISSION CONTROL NO: 176820 VIIBRYD TM is a trademark of Forest Laboratories, Inc., used under licence by Forest Laboratories Canada Inc. © 2014 Forest Laboratories Canada Inc. All Rights Reserved. _VIIBRYD_ _TM_ _ Product Monograph _ _Page 2 of 41 _ 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 ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................20 OVERDOSAGE ................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................22 STORAGE AND STABILITY ..........................................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ...............................................................................27 PHARMACEUTICAL INFORMATION .... Přečtěte si celý dokument