Country: Канада
Језик: Енглески
Извор: Health Canada
FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM)
VIIV HEALTHCARE ULC
J05AE07
FOSAMPRENAVIR
700MG
TABLET
FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) 700MG
ORAL
60
Prescription
HIV PROTEASE INHIBITORS
Active ingredient group (AIG) number: 0150429001; AHFS:
APPROVED
2009-12-08
_ _ _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 Прочитајте комплетан документ