JAMP ATOMOXETINE CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
19-10-2020
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:
JAMP PHARMA CORPORATION
ATC númer:
N06BA09
INN (Alþjóðlegt nafn):
ATOMOXETINE
Skammtar:
40MG
Lyfjaform:
CAPSULE
Samsetning:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 40MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0150434004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2020-10-20
Vara einkenni
JAMP ATOMOXETINE
Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
JAMP ATOMOXETINE
Atomoxetine Capsules
10, 18, 25, 40, 60, 80 and 100 mg atomoxetine (as atomoxetine
hydrochloride)
House standard
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Approval:
October 19, 2020
Submission Control No 235031
JAMP ATOMOXETINE
Product Monograph
Page 2
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
.............................................................................................
12
DRUG ABUSE AND DEPENDENCE
.........................................................................
22
DRUG INTERACTIONS
..............................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................
24
OVERDOSAGE
............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND STABILITY
.....................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 33
PART II: SCIENTIFIC INFORMATION
.........................................................................
34
PHARMACEUTICAL INFORMATION
........................................................
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