NORVIR CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
29-05-2019
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Aktiva substanser:
RITONAVIR
Tillgänglig från:
ABBVIE CORPORATION
ATC-kod:
J05AE03
INN (International namn):
RITONAVIR
Dos:
100MG
Läkemedelsform:
CAPSULE
Sammansättning:
RITONAVIR 100MG
Administreringssätt:
ORAL
Enheter i paketet:
2X84
Receptbelagda typ:
Prescription
Terapiområde:
HIV PROTEASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0128780001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2012-11-08
Produktens egenskaper
_ _
_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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