ACT SERTRALINE CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

থেকে পাওয়া:

ACTAVIS PHARMA COMPANY

এটিসি কোড:

N06AB06

INN (আন্তর্জাতিক নাম):

SERTRALINE

ডোজ:

25MG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0123417003; AHFS:

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2018-07-09

পণ্য বৈশিষ্ট্য

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................................................................................................