APO-POSACONAZOLE TABLET (DELAYED-RELEASE)
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
28-01-2021
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有効成分:
POSACONAZOLE
から入手可能:
APOTEX INC
ATCコード:
J02AC04
INN（国際名）:
POSACONAZOLE
投薬量:
100MG
医薬品形態:
TABLET (DELAYED-RELEASE)
構図:
POSACONAZOLE 100MG
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:
AZOLES
製品概要:
Active ingredient group (AIG) number: 0152201002; AHFS:
認証ステータス:
APPROVED
承認日:
2021-01-29
製品の特徴
Page 1 of 41
PRODUCT MONOGRAPH
PR
APO-POSACONAZOLE
Posaconazole Delayed-Release Tablets
100 mg posaconazole
Antifungal Agent
APOTEX INC.
150 SIGNET DRIVE,
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
January 28, 2021
Submission Control No: 232111
Page 1 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................................
2
SUMMARY PRODUCT INFORMATION
...............................................................................................
2
INDICATIONS AND CLINICAL USE
.....................................................................................................
2
CONTRAINDICATIONS
..........................................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................................
3
ADVERSE REACTIONS
...........................................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................................
19
OVERDOSAGE
.......................................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
21
STORAGE AND STABILITY
.................................................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
..............................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
25
PART II: SCIENTIFIC INFORMATION
................
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