INVIRASE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SAQUINAVIR (SAQUINAVIR MESYLATE)

から入手可能:

HOFFMANN-LA ROCHE LIMITED

ATCコード:

J05AE01

INN（国際名）:

SAQUINAVIR

投薬量:

500MG

医薬品形態:

TABLET

構図:

SAQUINAVIR (SAQUINAVIR MESYLATE) 500MG

投与経路:

ORAL

パッケージ内のユニット:

120

処方タイプ:

Prescription

治療領域:

HIV PROTEASE INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0128571002; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2021-01-06

製品の特徴

PRODUCT MONOGRAPH
Pr
INVIRASE
®
Saquinavir capsules 200 mg
(as saquinavir mesylate)
Saquinavir film-coated tablets 500mg
(as saquinavir mesylate)
Pharmaceutical standard professed
HIV Protease Inhibitor / Antiretroviral Agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
Date of Revision:
March 25, 2020
Submission Control No: 235283
®
INVIRASE is a registered trade-mark of Hoffmann-La Roche Limited
©
Copyright 1996–2020 Hoffmann-La Roche Limited
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_Page 2 of _59
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................31
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
....................................................