INVIRASE - CAP 200MG CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
25-03-2020
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:
SAQUINAVIR (SAQUINAVIR MESYLATE)
Fáanlegur frá:
HOFFMANN-LA ROCHE LIMITED
ATC númer:
J05AE01
INN (Alþjóðlegt nafn):
SAQUINAVIR
Skammtar:
200MG
Lyfjaform:
CAPSULE
Samsetning:
SAQUINAVIR (SAQUINAVIR MESYLATE) 200MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
270
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HIV PROTEASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0128571001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2018-12-31
Vara einkenni
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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