AG-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
17-04-2019
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有効成分:
OLANZAPINE
から入手可能:
ANGITA PHARMA INC.
ATCコード:
N05AH03
INN（国際名）:
OLANZAPINE
投薬量:
20MG
医薬品形態:
TABLET (ORALLY DISINTEGRATING)
構図:
OLANZAPINE 20MG
投与経路:
ORAL
パッケージ内のユニット:
100
処方タイプ:
Prescription
治療領域:
ATYPICAL ANTIPSYCHOTICS
製品概要:
Active ingredient group (AIG) number: 0128783006; AHFS:
認証ステータス:
APPROVED
承認日:
2019-04-18
製品の特徴
PRODUCT MONOGRAPH
PR
AG-OLANZAPINE FC
OLANZAPINE TABLETS
2.5 mg, 5mg, 7.5 mg, 10 mg, 15 mg and 20 mg Film Coated Tablets
MANUFACTURER’S STANDARD
PR
AG-OLANZAPINE ODT
OLANZAPINE ORALLY DISINTEGRATING TABLETS
5 mg, 10 mg, 15 mg and 20 mg Orally Disintegrating Tablets
MANUFACTURER’S STANDARD
Antipsychotic Agent
Angita Pharma Inc. Date of Preparation
1310 rue Nobel April 17, 2019
Boucherville, Québec
J4B 5H3
Submission Control No.: 225530
2
AG-OLANZAPINE FC and AG-OLANZAPINE ODT Product Monograph
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
........................................................................................
14
DRUG INTERACTIONS
.........................................................................................
28
DOSAGE AND ADMINISTRATION
.....................................................................
29
OVERDOSAGE
....................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
................................................... 32
STORAGE AND STABILITY
..............................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................... 34
PART II: SCIENTIFIC INFORMATION
................................................................ 36
PHARMACEUTICAL INFORMATION
................................................................ 36
CLINICAL TRIALS
................................................................................................
37
DETAILED
PHARMACOL
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