Land: Kanada
Sprache: Englisch
Quelle: Health Canada
ATAZANAVIR (ATAZANAVIR SULFATE)
APOTEX INC
J05AE08
ATAZANAVIR
200MG
CAPSULE
ATAZANAVIR (ATAZANAVIR SULFATE) 200MG
ORAL
30/60/500
Prescription
HIV PROTEASE INHIBITORS
Active ingredient group (AIG) number: 0149741003; AHFS:
APPROVED
2018-07-23
_APO-ATAZANAVIR PRODUCT MONOGRAPH _ _ _ _ _ _ PAGE 1 OF 84 _ PRODUCT MONOGRAPH PR APO-ATAZANAVIR Atazanavir capsules Apotex Standard 150 mg, 200 mg and 300 mg, Oral (as atazanavir sulfate) Azapeptide Inhibitor of HIV-1 Protease APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE AUGUST 21, 2020 TORONTO, ONTARIO M9L 1T9 CONTROL NUMBER: 242061 _APO-ATAZANAVIR PRODUCT MONOGRAPH _ _ _ _ _ _ PAGE 2 OF 84 _ Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 11 DRUG INTERACTIONS ......................................................................................................... 23 DOSAGE AND ADMINISTRATION ..................................................................................... 43 OVERDOSAGE ........................................................................................................................ 46 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 47 STORAGE AND STABILITY ................................................................................................. 51 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 51 PART II: SCIENTIFIC INFORMATION ............................................................................... 53 PHARMACEUTICAL INFORMATION ................................................................................. 53 Lesen Sie das vollständige Dokument