AG-QUETIAPINE FUMARATE TABLET (IMMEDIATE RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
11-06-2021
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:
300MG
Lyfjaform:
TABLET (IMMEDIATE RELEASE)
Samsetning:
QUETIAPINE (QUETIAPINE FUMARATE) 300MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ATYPICAL ANTIPSYCHOTICS
Vörulýsing:
Active ingredient group (AIG) number: 0131858005; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-06-14
Vara einkenni
Page 1 of 59
PRODUCT MONOGRAPH
PR
AG-QUETIAPINE FUMARATE
Quetiapine Tablets USP
25 mg, 100 mg, 200 mg and 300 mg
quetiapine (as quetiapine fumarate)
Antipsychotic Agent
_ANGITA PHARMA INC. _
_DATE OF REVISION:_
1310 rue Nobel
June 11, 2021
Boucherville, Québec
J4B 5H3
Submission Control No.: 252148
Page 2 of 59
TABLE OF CONTENTS
PRODUCT MONOGRAPH
....................................................................................................
1
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
...............................................................................................
15
DRUG INTERACTIONS
...............................................................................................
31
DOSAGE AND ADMINISTRATION
...........................................................................
33
OVERDOSAGE
.............................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 36
STORAGE AND STABILITY
.......................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 38
PART II: SCIENTIFIC INFORMATION
.............................................................................
39
PHARMACEUTICAL INFORMATION
.......................................................................
39
CLINICAL TRIALS
..........................................................................
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