NORVIR CAPSULE
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
29-05-2019
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Aktiv ingrediens:
RITONAVIR
Tilgjengelig fra:
ABBVIE CORPORATION
ATC-kode:
J05AE03
INN (International Name):
RITONAVIR
Dosering :
100MG
Legemiddelform:
CAPSULE
Sammensetning:
RITONAVIR 100MG
Administreringsrute:
ORAL
Enheter i pakken:
2X84
Resept typen:
Prescription
Terapeutisk område:
HIV PROTEASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0128780001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2012-11-08
Preparatomtale
_ _
_NORVIR Product Monograph _
_Page 1 of 64 _
PRODUCT MONOGRAPH
PR
NORVIR
®
Ritonavir
film-coated tablets (100 mg)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
AbbVie Corporation
Date of Revision:
8401 Trans-Canada Highway
May 29, 2019
St-Laurent, Qc H4S 1Z1
Submission Control No: 226180
_ _
_NORVIR Product Monograph _
_Page 2 of 64 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................42
OVERDOSAGE
................................................................................................................43
ACTION AND CLINICAL PHARMACOLOGY
............................................................44
STORAGE AND STABILITY
..........................................................................................48
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................48
PART II: SCIENTIFIC INFORMATION
................................................................................49
PHARMACEUTICAL INFORMATION
..........................................................................49
CLINICAL TRIALS
..........................................................................................................50
MICROBIOLOGY
...............
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