APO-ATOMOXETINE CAPSULE
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
13-01-2016
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
Fáanlegur frá:
APOTEX INC
ATC númer:
N06BA09
INN (Alþjóðlegt nafn):
ATOMOXETINE
Skammtar:
10MG
Lyfjaform:
CAPSULE
Samsetning:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 10MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/1000
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0150434001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2010-09-21
Vara einkenni
Page 1 of 60
PRODUCT MONOGRAPH
PR
APO-ATOMOXETINE
ATOMOXETINE HYDROCHLORIDE CAPSULES
10 MG, 18 MG, 25 MG, 40 MG, 60 MG, 80 MG AND 100 MG*
*ATOMOXETINE AS ATOMOXETINE HYDROCHLORIDE
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF REVISION:
January 8, 2016
SUBMISSION CONTROL NO: 190898
Page 2 of 60
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 ABUSE AND DEPENDENCE
.........................................................................
23
DRUG INTERACTIONS
............................................................................................
24
DOSAGE AND ADMINISTRATION
........................................................................
26
OVERDOSAGE
............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 30
STORAGE AND STABILITY
.....................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 35
PART II: SCIENTIFIC INFORMATION
............................................................... 37
PHARMACEUTICAL INFORMATION
.....................................................................
37
CLINICAL TRIALS
...............................................................
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