AG-QUETIAPINE XR TABLET (EXTENDED-RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
20-09-2021
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:
QUETIAPINE (QUETIAPINE FUMARATE)
Fáanlegur frá:
ANGITA PHARMA INC.
ATC númer:
N05AH04
INN (Alþjóðlegt nafn):
QUETIAPINE
Skammtar:
200MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
QUETIAPINE (QUETIAPINE FUMARATE) 200MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ATYPICAL ANTIPSYCHOTICS
Vörulýsing:
Active ingredient group (AIG) number: 0131858003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-09-21
Vara einkenni
PRODUCT MONOGRAPH
PR
AG-QUETIAPINE XR
Quetiapine Fumarate Extended-Release Tablets
50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as quetiapine
fumarate)
House Standard
Antipsychotic / Antidepressant Agent
Angita Pharma Inc.
Date of Preparation:
1310 rue Nobel
September 20, 2021
Boucherville, Québec
J4B 5H3, Canada
Submission Control No: 255711
Product Monograph of AG-Quetiapine XR
Page 2 of 79
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
.........................................................................................................
17
DRUG INTERACTIONS
.........................................................................................................
37
DOSAGE AND ADMINISTRATION
.....................................................................................
39
OVERDOSAGE
........................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
44
STORAGE AND STABILITY
.................................................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 47
PART II: SCIENTIFIC INFORMATION
...............................................................................48
PHARMACEUTICAL INFORMATION
.................................................................................
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