INVIRASE - CAP 200MG CAPSULE
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
25-03-2020
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Aktiv bestanddel:
SAQUINAVIR (SAQUINAVIR MESYLATE)
Tilgængelig fra:
HOFFMANN-LA ROCHE LIMITED
ATC-kode:
J05AE01
INN (International Name):
SAQUINAVIR
Dosering:
200MG
Lægemiddelform:
CAPSULE
Sammensætning:
SAQUINAVIR (SAQUINAVIR MESYLATE) 200MG
Indgivelsesvej:
ORAL
Enheder i pakken:
270
Recept type:
Prescription
Terapeutisk område:
HIV PROTEASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0128571001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2018-12-31
Produktets egenskaber
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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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
....................................................
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