TELZIR TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
05-07-2019
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Aktiv ingrediens:
FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM)
Tilgjengelig fra:
VIIV HEALTHCARE ULC
ATC-kode:
J05AE07
INN (International Name):
FOSAMPRENAVIR
Dosering :
700MG
Legemiddelform:
TABLET
Sammensetning:
FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) 700MG
Administreringsrute:
ORAL
Enheter i pakken:
60
Resept typen:
Prescription
Terapeutisk område:
HIV PROTEASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0150429001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2009-12-08
Preparatomtale
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_Page 1 of 55_
PRODUCT MONOGRAPH
PR
TELZIR
Fosamprenavir tablets 700 mg
(as fosamprenavir calcium)
Fosamprenavir oral suspension 50 mg/mL
(as fosamprenavir calcium)
Antiretroviral Agent
ViiV Healthcare ULC
245, boulevard Armand-Frappier
Laval, Quebec
H7V 4A7
Date of Revision:
July 5, 2019
Submission Control No.: 226294
© 2019 ViiV Healthcare group of companies or its licensor.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
_ _
_Page 2 of 55_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................36
PHARMACEUTICAL INFORM
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