ACT SERTRALINE CAPSULE
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
28-10-2016
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Aktívna zložka:
SERTRALINE (SERTRALINE HYDROCHLORIDE)
Dostupné z:
ACTAVIS PHARMA COMPANY
ATC kód:
N06AB06
INN (Medzinárodný Name):
SERTRALINE
Dávkovanie:
100MG
Forma lieku:
CAPSULE
Zloženie:
SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG
Spôsob podávania:
ORAL
Počet v balení:
100/250
Typ predpisu:
Prescription
Terapeutické oblasti:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Prehľad produktov:
Active ingredient group (AIG) number: 0123417002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-07-09
Súhrn charakteristických
Page 1 of 53
PRODUCT MONOGRAPH
P
PR
ACT SERTRALINE
Sertraline as Sertraline Hydrochloride
Capsules, 25 mg, 50 mg and 100 mg
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Control No.: 198893
Date of Revision:
October 24, 2016
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
...............................................................................................4
WARNINGS AND PRECAUTIONS
..............................................................................5
ADVERSE REACTIONS
..............................................................................................
13
DRUG INTERACTIONS
..............................................................................................
21
DOSAGE AND ADMINISTRATION
...........................................................................
26
OVERDOSAGE
............................................................................................................
28
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
INFORMATION.......................................................................
33
CLINICAL
TRIALS................................................................................................
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