TELZIR TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM)

Dostupno od:

VIIV HEALTHCARE ULC

ATC koda:

J05AE07

INN (International ime):

FOSAMPRENAVIR

Doziranje:

700MG

Farmaceutski oblik:

TABLET

Sastav:

FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) 700MG

Administracija rute:

ORAL

Jedinice u paketu:

60

Tip recepta:

Prescription

Područje terapije:

HIV PROTEASE INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0150429001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2009-12-08

Svojstava lijeka

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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